MedPath

Aldosterone Antagonist Therapy for Adults With Heart Failure and Preserved Systolic Function

Phase 3
Completed
Conditions
Heart Diseases
Heart Failure, Congestive
Cardiovascular Diseases
Interventions
Registration Number
NCT00094302
Lead Sponsor
Carelon Research
Brief Summary

The purpose of this study is to evaluate the effectiveness of aldosterone antagonist therapy in reducing cardiovascular mortality, aborted cardiac arrest, and heart failure hospitalization in patients who have heart failure with preserved systolic function.

Detailed Description

BACKGROUND:

Heart failure (HF) is a major cause of morbidity and mortality, particularly in older people. Indeed, it is the most common discharge diagnosis in patients older than 65 years. As the United States population ages, heart failure will continue to grow as a public health concern. Therapeutic trials of heart failure have dealt almost exclusively with patients who have systolic dysfunction. However, there is now an emerging awareness that nearly half of the patients with heart failure have preserved systolic function and that the survival of these patients is adversely affected. This study is a randomized clinical trial of a novel therapeutic approach, specifically the use of spironolactone, an aldosterone antagonist, in treating these patients. While this treatment has been shown to be useful in treating heart failure with reduced systolic function, it has not been studied in patients with preserved systolic function.

Patients with heart failure and preserved systolic function have a poor prognosis. The annual mortality rate is intermediate between the prognosis for those without heart failure and for those with heart failure and reduced systolic function. For instance, Family Health Study participants with heart failure and preserved systolic function had a mortality rate of 9% compared to 3% for their age- and gender-matched controls. The mortality rate was 19% in heart failure patients with reduced systolic function heart failure compared to 4% for their matched controls.

As heart failure develops, neurohormones are released that initially improve cardiac output but ultimately contribute to progression of left ventricular dysfunction. The renin-angiotensin-aldosterone system is an important part of this compensatory response. Aldosterone levels may rise to 20 times normal levels in heart failure and aldosterone contributes to the development of myocardial fibrosis. Spironolactone is a potassium-sparing diuretic that acts on the distal tubule, inhibiting sodium and potassium ion exchange. There are several potential beneficial actions, including prevention of cardiac fibrosis. A recent trial evaluated spironolactone in patients with systolic dysfunction heart failure. Spironolactone treatment caused a 30% reduction in mortality compared to placebo (p\< 0.001). The improvement resulted from a reduction in all cause mortality. More recently, the Eplerenone Post-Myocardial Infarction (MI) study showed that this aldosterone antagonist significantly reduces mortality despite background treatment with an angiotensin-converting enzyme (ACE) inhibitor and beta-blocker. Advantages of using spironolactone in this study are that it is commercially available, inexpensive, and no longer under patent (therefore this study will not be done by industry). Also, there is a clear physiologic rationale for its use, and the side effect profile is well understood. The study enrolled subjects who had preserved systolic function with heart failure and who met clearly defined eligibility criteria that were selected to make the results widely generalizable to clinical practice.

DESIGN NARRATIVE:

This is a randomized, double-blinded, placebo-controlled trial of aldosterone antagonist therapy (15 mg dose spironolactone or placebo; titrated up to 30 or 45 mg/day) in 3,445 adult patients with heart failure and preserved systolic function. Patients were recruited from August 2006 through January 2012, treated, and will be followed through June 2013. Approximately 270 clinical sites in six countries were subcontracted by the clinical trial coordinating center. Subject visits to a clinical center will occur every four or six months. Data collected include demographic and clinical data, including the results of history and physical exams, laboratory and imaging data, repository specimens for special physiology studies, and genetic studies. Additionally, data regarding quality of life and compliance with assigned treatment will also be collected and assessed.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
3445
Inclusion Criteria

Not provided

Read More
Exclusion Criteria

Not provided

Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PlaceboPlaceboPlacebo of spironolactone
SpironolactoneSpironolactoneSpironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
Primary Outcome Measures
NameTimeMethod
Composite Outcome of Cardiovascular Mortality, Aborted Cardiac Arrest, or Hospitalization for the Management of Heart Failure, Whichever Occurred FirstRandomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.
Secondary Outcome Measures
NameTimeMethod
Cardiovascular MortalityRandomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.
Total Hospitalizations (Including Repeat Hospitalizations) for the Management of Heart FailureRandomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.
Deterioration of Renal FunctionRandomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

First incidence of a deterioration of renal function. The TOPCAT protocol defines deterioration of renal function as occurring if a subject has a serum creatinine value which is at least double the baseline value for that subject, and is also above the upper limit of normal (assumed to be 1.0 mg/dL for females and 1.2 mg/dL for males.)

Composite Outcome of Sudden Death, Aborted Cardiac Arrest, or Hospitalization for the Management of Ventricular Tachycardia, Whichever Occurred FirstRandomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.
Aborted Cardiac ArrestRandomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

First incidence of aborted cardiac arrest

All-cause MortalityRandomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.
Composite Outcome of Cardiovascular Mortality or Cardiovascular-related Hospitalization (i.e., Hospitalization for Myocardial Infarction(MI), Stroke, or the Management of Heart Failure), Whichever Occurred FirstRandomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.
Composite Outcome of Sudden Death or Aborted Cardiac Arrest, Whichever Occurred FirstRandomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.
Hospitalization for Any ReasonRandomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

First incidence of a hospitalization for any reason

Serum CreatinineRandomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Average post-baseline serum creatinine, taking into consideration baseline serum creatinine, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.

Hospitalization for the Management of Heart FailureRandomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

First incidence of a hospitalization for the management of heart failure

Myocardial InfarctionRandomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

First incidence of myocardial infarction

Quality of Life, as Measured by the EuroQOL Visual Analog Scale.Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Average post-baseline quality of life, taking into consideration baseline quality of life, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.

The EuroQOL visual analog scale (EQ5D) is a single-item, self-administered instrument that quantifies current health status. Scores can range from 0-100, in which higher scores reflect better health status. The EQ5D was administered at the following study visits: baseline, month 4, month 12 and annually thereafter.

Quality of Life, as Measured by McMaster Overall Treatment Evaluation Questionnaire.Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Average post-baseline quality of life, taking into consideration baseline quality of life and treatment group.

The McMaster Overall Treatment Evaluation questionnaire is a self-administered 3-item instrument that measures a patient's perception of change in their health-related quality of life since the start of therapy. The questionnaire consists of a single question - "Since treatment started, has there been any change in your activity limitation, symptoms and/or feelings related to your heart condition?" Scores can range from -7 to +7, and higher scores reflect better health status. The questionnaire was administered at the following study visits: month 4 and month 12. Valid translations of this questionnaire were only available for subjects enrolled in the United States, Canada and Argentina.

PotassiumRandomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Average post-baseline Potassium, taking into consideration baseline Potassium, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.

Quality of Life, as Measured by the Kansas City Cardiomyopathy Questionnaire.Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Average post-baseline quality of life, taking into consideration baseline quality of life, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.

The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. The KCCQ was administered at the following study visits: baseline, month 4, month 12 and annually thereafter.

Depression Symptoms, as Measured by Patient Health Questionnaire.Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Average post-baseline depression, taking into consideration baseline depression, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.

The Patient Health Questionnaire (PHQ) is a 10-item, self-administered instrument for screening, diagnosing, monitoring and measuring the severity of depression. Scores can range from 0-27, in which lower scores reflect better mental health status. The PH-Q was administered at the following study visits: baseline, month 12 and annually thereafter. Valid translations of this questionnaire were only available for subjects enrolled in the United States and Canada.

SodiumRandomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Average post-baseline Sodium, taking into consideration baseline Sodium, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.

Estimated Glomerular Filtration Rate (GFR)Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Average post-baseline GFR, taking into consideration baseline GFR, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.

Cardiovascular-related HospitalizationRandomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Hospitalization for MI, stroke or the management of heart failure, whichever occurred first

New Onset Diabetes Mellitus, Among Subjects Without a History of Diabetes Mellitus at Baseline.Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

First incidence of new onset diabetes mellitus among subjects without a history of diabetes mellitus at baseline.

Development of Atrial Fibrillation, Among Subjects Without a History of Atrial Fibrillation at Baseline.Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

First incidence of atrial fibrillation among subjects without a history of atrial fibrillation at baseline

StrokeRandomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

First incidence of stroke

ChlorideRandomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Average post-baseline Chloride, taking into consideration baseline Chloride, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.

Trial Locations

Locations (269)

Drexel University College of Medicine

🇺🇸

Philadelphia, Pennsylvania, United States

University of Pennsylvania

🇺🇸

Philadelphia, Pennsylvania, United States

Cardiovascular Research Institute of Dallas

🇺🇸

Dallas, Texas, United States

Aspirus Heart and Vascular Institute

🇺🇸

Wausau, Wisconsin, United States

Mount Sinai Hospital

🇨🇦

Toronto, Ontario, Canada

Morehouse School of Medicine

🇺🇸

Atlanta, Georgia, United States

Boston University Medical Center

🇺🇸

Boston, Massachusetts, United States

University Hospitals of Cleveland/Case Western Reserve University

🇺🇸

Cleveland, Ohio, United States

Ohio State University Hospital East

🇺🇸

Columbus, Ohio, United States

Michael E. DeBakey VA Medical Cntr.

🇺🇸

Houston, Texas, United States

The Methodist Hospital Research Institute

🇺🇸

Houston, Texas, United States

LDS Hospital

🇺🇸

Murray, Utah, United States

Santa Casa de Misericordia do Rio de Janeiro

🇧🇷

Rio de Janeiro, Brazil

Instituto de Cardiologia de Santa Catarina

🇧🇷

Santa Catarina, Brazil

Clinique Cardiologie Levis

🇨🇦

Levis, Quebec, Canada

Hopital Du Sacre Coeur de Montreal

🇨🇦

Montreal, Quebec, Canada

CHUM - Hotel Dieu

🇨🇦

Montreal, Quebec, Canada

Chair of Nephrology and Dialysis of St Petersburg State Medical University

🇷🇺

Saint Petersburg, Russian Federation

The Care Group, LLC

🇺🇸

Indianapolis, Indiana, United States

Minneapolis VA Medical Center

🇺🇸

Minneapolis, Minnesota, United States

Cardiology Clinic of San Antonio

🇺🇸

San Antonio, Texas, United States

Clinica IMA

🇦🇷

Buenos Aires, Argentina

Clinica Privada Del Prado

🇦🇷

Cordoba, Argentina

PROCAPE

🇧🇷

Pernambuco, Brazil

Vanderbilt Heart and Vascular Institute

🇺🇸

Nashville, Tennessee, United States

University of Utah

🇺🇸

Salt Lake City, Utah, United States

St. Boniface General Hospital

🇨🇦

Winnipeg, Manitoba, Canada

Ochsner Clinic Foundation

🇺🇸

New Orleans, Louisiana, United States

Detroit VA Medical Center

🇺🇸

Detroit, Michigan, United States

Henry Ford Hospital

🇺🇸

Detroit, Michigan, United States

Central Arkansas Veterans Healthcare System

🇺🇸

Little Rock, Arkansas, United States

Heart Clinic Arkansas

🇺🇸

Little Rock, Arkansas, United States

Cardiovascular Consultants, Ltd.

🇺🇸

Glendale, Arizona, United States

Washington DC VA Hospital

🇺🇸

Washington, District of Columbia, United States

Washington Hospital Center

🇺🇸

Washington, District of Columbia, United States

Sinai Hospital of Baltimore

🇺🇸

Baltimore, Maryland, United States

Memphis Heart Clinic

🇺🇸

Memphis, Tennessee, United States

Deborah Heart and Lung Center

🇺🇸

Browns Mills, New Jersey, United States

University of Cincinnati

🇺🇸

Cincinnati, Ohio, United States

The Stern Cardiovascular Center

🇺🇸

Germantown, Tennessee, United States

Bryan LGH Heart Institute

🇺🇸

Lincoln, Nebraska, United States

MetroHealth Medical Center

🇺🇸

Cleveland, Ohio, United States

NJ Heart

🇺🇸

Linden, New Jersey, United States

Sanatorio Mayo S.A.

🇦🇷

Santa Fe, Argentina

Instituto de Cardiologia SRL

🇦🇷

Tucuman, Argentina

CHUS - Hopital Fleurimont

🇨🇦

Fleurimont, Quebec, Canada

Baystate Medical Center

🇺🇸

Springfield, Massachusetts, United States

Glacier View Cardiology

🇺🇸

Kalispell, Montana, United States

St. Joseph's Regional Medical Center

🇺🇸

Paterson, New Jersey, United States

The Valley Hospital

🇺🇸

Ridgewood, New Jersey, United States

Memphis VA Medical Center

🇺🇸

Memphis, Tennessee, United States

Cardiovascular Associates of the Delaware Valley

🇺🇸

Haddon Heights, New Jersey, United States

CAMC Health Education and Research Institute

🇺🇸

Charleston, West Virginia, United States

University of Tennessee Health Science Center

🇺🇸

Memphis, Tennessee, United States

University of Wisconsin-Madison

🇺🇸

Madison, Wisconsin, United States

Centro de Investigaciones Clinicas del Litoral SRL

🇦🇷

Santa Fe, Argentina

Centro Modelo de Cardiología

🇦🇷

Tucuman, Argentina

Instituto de Investigaciones Clinicas de Bahia Blanca

🇦🇷

Bahia Blanca, Buenos Aires, Argentina

Fraser Clinical Trials Inc.

🇨🇦

New Westminster, British Columbia, Canada

University of Washington

🇺🇸

Seattle, Washington, United States

Montreal Heart Institute

🇨🇦

Montreal, Quebec, Canada

Kaliningrad Region Hospital

🇷🇺

Kaliningrad, Russian Federation

Instituto de Investigaciones Clinicas de Quilmes

🇦🇷

Quilmes, Buenos Aires, Argentina

IMAI Research

🇦🇷

Buenos Aires, Argentina

CIPREC

🇦🇷

Buenos Aires, Argentina

Montreal General Hospital

🇨🇦

Montreal, Quebec, Canada

Centre Hosp Regional de Lanaudiere

🇨🇦

Sainte Charles Borromee, Quebec, Canada

Cardiology Clinic

🇬🇪

Tibilisi, Georgia

Municipal Health Care Institution "City Hospital #1"

🇷🇺

Barnaul, Russian Federation

Saint-Petersburg State Healthcare Institution "City Alexander's Hospital"

🇷🇺

Saint Petersburg, Russian Federation

Capital District Health Authority

🇨🇦

Halifax, Nova Scotia, Canada

Health Science Centre

🇨🇦

St. John's, Newfoundland and Labrador, Canada

Hospital Italiano de La Plata

🇦🇷

La Plata, Buenos Aires, Argentina

Policlinico Modelo de Cipoletti

🇦🇷

Cipolletti, Rio Negro, Argentina

University of Calgary

🇨🇦

Calgary, Alberta, Canada

Cite de la Sante de Laval

🇨🇦

Laval, Quebec, Canada

Hopital Laval

🇨🇦

Ste-Foy, Quebec, Canada

Tbilisi State Medical University Clinic #1

🇬🇪

Tbilisi, Georgia

Multiprofile Clinical Hospital of Tbilisi #2

🇬🇪

Tbilisi, Georgia

Diagnostic Services Clinic

🇬🇪

Tbilisi, Georgia

Medico- Military Academy, Navy Therapy Dept

🇷🇺

Saint-Petersburg, Russian Federation

Saint-Petersburg State Health Care Institution "City Hospital of Saint George the Martyr"

🇷🇺

St. Petersburg, Russian Federation

City Hospital #26

🇷🇺

St. Petersburg, Russian Federation

National Research Center for Preventitive Medicine

🇷🇺

Moscow, Russian Federation

Non State Health Care Institution Central Hospital #6 of Russian Railways JSC

🇷🇺

Moscow, Russian Federation

State Education High Professional Education Russian State Medical University

🇷🇺

Moscow, Russian Federation

Centre de recherche clinique de Quebec

🇨🇦

Quebec City, Quebec, Canada

C.S.S.S.B.

🇨🇦

St. George, Quebec, Canada

Municipal Healthcare Institution <>

🇷🇺

Gatchina, Leningrad Region, Russian Federation

Kemerovo Cadiologiy Dispensary, Kemerovo Medical Academy

🇷🇺

Kemerovo, Russian Federation

Nonstate Healthcare Institution

🇷🇺

Kemerovo, Russian Federation

State Institution Saint-Petersburg Dzhanelidze Scientific

🇷🇺

St. Petersburg, Russian Federation

Centre De Sante et De Services Sociaux De Thetford

🇨🇦

Thetford-Mines, Quebec, Canada

Royal Victoria Hospital

🇨🇦

Montreal, Quebec, Canada

Saint-Petersburg State Institution of Health Protection, "City Hosptial # 15"

🇷🇺

Saint Petersburg, Russian Federation

Federal State Health Care Institution

🇷🇺

Saint-Petersburg, Russian Federation

Non-state Health Care Institution

🇷🇺

St. Petersburg, Russian Federation

City Hospital No 26

🇷🇺

St. Petersburg, Russian Federation

Saint-Petersburg Clinical Hospital of RAMS, policlinic department

🇷🇺

St. Petersburg, Russian Federation

Hospital Sao Vicente de Paulo

🇧🇷

Passo Fundo, Brazil

University of Colorado Health Sciences Center

🇺🇸

Aurora, Colorado, United States

The Creighton Cardiac Center

🇺🇸

Omaha, Nebraska, United States

L &J Clinic

🇬🇪

Kutaisi, Georgia

University of Alabama at Birmingham

🇺🇸

Birmingham, Alabama, United States

Carl T. Hayden VA Medical Center

🇺🇸

Phoenix, Arizona, United States

Cynthia Thaik

🇺🇸

Burbank, California, United States

Fresno VA Medical Center

🇺🇸

Fresno, California, United States

Clinica Medica San Miguel

🇺🇸

Los Angeles, California, United States

CAPRI

🇺🇸

Los Angeles, California, United States

VA Medical Center West Los Angeles

🇺🇸

Los Angeles, California, United States

Mehrdad Kevin Ariani, MD, Inc.

🇺🇸

Northridge, California, United States

UC Davis Medical Center

🇺🇸

Sacremento, California, United States

Central Coast Cardiology

🇺🇸

Salinas, California, United States

Naval Medical Center San Diego

🇺🇸

San Diego, California, United States

Olive View - UCLA Medial Center

🇺🇸

Sylmar, California, United States

Cardio-Vascular Institute

🇺🇸

Greeley, Colorado, United States

University of Connecticut Health Center

🇺🇸

Farmington, Connecticut, United States

Howard University Hospital

🇺🇸

Washington DC, District of Columbia, United States

M & O Clinical Research, LLC

🇺🇸

Ft. Lauderdale, Florida, United States

Daytona Heart Group

🇺🇸

Daytona Beach, Florida, United States

Florida Heart Center

🇺🇸

Ft. Pierce, Florida, United States

Emory University at Grady Health System

🇺🇸

Atlanta, Georgia, United States

Mayo Clinic Florida

🇺🇸

Jacksonville, Florida, United States

University of Florida

🇺🇸

Gainesville, Florida, United States

Tallahassee Research Institute

🇺🇸

Tallahassee, Florida, United States

Northside Cardiology Center

🇺🇸

Atlanta, Georgia, United States

InnovaMed Alliance

🇺🇸

Marietta, Georgia, United States

Northwestern University

🇺🇸

Chicago, Illinois, United States

Heart, Lung and Vascular Institute

🇺🇸

Peoria, Illinois, United States

HeartCare Midwest

🇺🇸

Peoria, Illinois, United States

Rush University Medical Center

🇺🇸

Chicago, Illinois, United States

Cardiovascular Research Foundation

🇺🇸

Elk Grove Village, Illinois, United States

University of Illinois at Chicago Medical Center

🇺🇸

Chicago, Illinois, United States

Cardiovascular Research of Northwest Indiana, LLC

🇺🇸

Munster, Indiana, United States

Baptist Healthcare System, Inc. d/b/a Baptist Hospital East

🇺🇸

Louisville, Kentucky, United States

University of Iowa Hospitals and Clinics

🇺🇸

Iowa City, Iowa, United States

Leonard J. Chabert Medical Center

🇺🇸

Houma, Louisiana, United States

Northeast Cardiology

🇺🇸

Bangor, Maine, United States

University of Maryland Medical Center

🇺🇸

Baltimore, Maryland, United States

Kaiser Permanente

🇺🇸

Largo, Maryland, United States

Delmarva Heart Research Foundation

🇺🇸

Salisbury, Maryland, United States

Brigham and Women's Hospital

🇺🇸

Boston, Massachusetts, United States

Caritas St. Elizabeth's Medical Center

🇺🇸

Boston, Massachusetts, United States

Merrimack Valley Cardiology Associates

🇺🇸

Chelmsford, Massachusetts, United States

Pentucket Medical Associates

🇺🇸

Haverhill, Massachusetts, United States

Compass Medical East Bridgewater

🇺🇸

East Bridgewater, Massachusetts, United States

Charles River Medical Associates

🇺🇸

Natick, Massachusetts, United States

Hawthorn Medical Associates

🇺🇸

North Dartmouth, Massachusetts, United States

Umass Memorial Medical Center

🇺🇸

Worcester, Massachusetts, United States

Veterans Affairs Ann Arbor Health Care System

🇺🇸

Ann Arbor, Michigan, United States

Oakwood Hospital and Medical Center

🇺🇸

Dearborn, Michigan, United States

Heartland Regional Medical Clinic

🇺🇸

St. Joseph, Missouri, United States

Electrophysiology Research Foundation

🇺🇸

Somerset, New Jersey, United States

Community Medical Center

🇺🇸

Toms River, New Jersey, United States

New Jersey Cardiology Associates

🇺🇸

West Orange, New Jersey, United States

Bronx-Lebanon Hospital Center

🇺🇸

Bronx, New York, United States

Research Foundation State University of New York at Buffalo

🇺🇸

Buffalo, New York, United States

Buffalo Heart Group, LLC

🇺🇸

Buffalo, New York, United States

Mid Valley Cardiology

🇺🇸

Kingston, New York, United States

Winthrop Cardiology Associates

🇺🇸

Mineola, New York, United States

NYU School of Medicine

🇺🇸

New York, New York, United States

Soundshore Medical Center of Westchester

🇺🇸

New Rochelle, New York, United States

St. Lukes Roosevelt

🇺🇸

New York, New York, United States

Northport VA Medical Center

🇺🇸

Northport, New York, United States

University of Rochester Medical Center

🇺🇸

Rochester, New York, United States

SUNY Upstate Medical Center

🇺🇸

Syracuse, New York, United States

Syracuse VA Medical Center

🇺🇸

Syracuse, New York, United States

Northeast Medical Center

🇺🇸

Concord, North Carolina, United States

Wake Forest University Health Sciences

🇺🇸

Winston-Salem, North Carolina, United States

The Lindner Clinical Trial Center

🇺🇸

Cincinnati, Ohio, United States

VAMC Dayton

🇺🇸

Dayton, Ohio, United States

COR Clinical Research

🇺🇸

Oklahoma City, Oklahoma, United States

CCHS Clinical Research Office/ Hillcrest Hospital

🇺🇸

Mayfield Heights, Ohio, United States

Oklahoma City VA Medical Center

🇺🇸

Oklahoma City, Oklahoma, United States

Oklahoma Foundation for Cardiovascular Research

🇺🇸

Oklahoma City, Oklahoma, United States

CCHS Clinical Research Office/Marymount Hospital

🇺🇸

Garfield Heights, Ohio, United States

St. Charles Health System

🇺🇸

Bend, Oregon, United States

Capital Area Research

🇺🇸

Camp Hill, Pennsylvania, United States

Providence Heart and Vascular Institute

🇺🇸

Portland, Oregon, United States

Medicor Associates, Inc

🇺🇸

Erie, Pennsylvania, United States

The Milton S. Hershey Medical Center

🇺🇸

Hershey, Pennsylvania, United States

Lancaster Heart and Stroke Foundation

🇺🇸

Lancaster, Pennsylvania, United States

Temple University Hospital

🇺🇸

Philadelphia, Pennsylvania, United States

Thomas Jefferson University Hospital- Dept. of Family and Community Health

🇺🇸

Philadelphia, Pennsylvania, United States

Eastwick Primary Care

🇺🇸

Philadelphia, Pennsylvania, United States

Pittsburgh VA Healthcare System

🇺🇸

Pittsburgh, Pennsylvania, United States

The Reading Hospital and Medical Center

🇺🇸

West Reading, Pennsylvania, United States

Memorial Hospital Rhode Island

🇺🇸

Pawtucket, Rhode Island, United States

VAMC - Charleston, SC

🇺🇸

Charleston, South Carolina, United States

Black Hills VA Health Care System

🇺🇸

Ft. Meade, South Dakota, United States

DCT - APHC, LLC dba Discovery Clinical Trials

🇺🇸

Arlington, Texas, United States

U.T. Southwestern Medical Center

🇺🇸

Dallas, Texas, United States

Wilford Hall Medical Center

🇺🇸

Lackland, Texas, United States

Tyler Cardiovascular Consultants

🇺🇸

Tyler, Texas, United States

Texas Tech University Health Sciences Center

🇺🇸

Odessa, Texas, United States

Sentara Cardiovascular Research Institute

🇺🇸

Norfolk, Virginia, United States

Cardiovascular Associates Ltd.

🇺🇸

Chesapeake, Virginia, United States

Evergreen Healthcare

🇺🇸

Kirkland, Washington, United States

Providence St. Peter Hospital

🇺🇸

Olympia, Washington, United States

Sound Health Research

🇺🇸

Port Orchard, Washington, United States

William S. Middleton Memorial VA Hospital

🇺🇸

Madison, Wisconsin, United States

Instituto de Investigaciones Clinicas de Mar Del Plata

🇦🇷

Mar del Plata, Buenos Aires, Argentina

Clinica Coronel Suarez

🇦🇷

Coronel Suarez, Buenos Aires, Argentina

Instituto Cardiologico Ezpecializado S.R.L

🇦🇷

Buenos Aires, Argentina

Instituto de Investigaciones Clinicas de Rosario

🇦🇷

Rosario Santa Fe, Argentina

Hospital San Bernardo

🇦🇷

Salta, Argentina

Centro Privado de Cardiologia

🇦🇷

Tucuman, Argentina

Santa Casa De Belo Horizonte

🇧🇷

Belo Horizonte, Brazil

Hospital Felicio Rocho

🇧🇷

Belo Horizonte, Brazil

Irmandade da Santa Casa de Misericordia de Curitiba

🇧🇷

Curitiba Parana, Brazil

Instituto do Coracao de Marilia

🇧🇷

Marilia Sao Paulo, Brazil

HMCP PUC Campinas

🇧🇷

Campinas, Brazil

Hospital das Clinicas da Universidade Federal de Goias

🇧🇷

Goias, Brazil

Hospital de Clinicas de Porto Alegre

🇧🇷

Porto Alegre, Brazil

Hospital Mae De Deus

🇧🇷

Porto Alegre, Brazil

Hospital Universitario Pedro Ernesto

🇧🇷

Rio de Janeiro, Brazil

Incor Fmusp

🇧🇷

Sao Paulo, Brazil

Instituto de Molestias Cardiosvaculares

🇧🇷

San Paulo, Brazil

Instituto do Coracao do Triangulo Mineiro

🇧🇷

Uberlandia, Brazil

UNIFESP/Hospital Sao Paulo

🇧🇷

Sao Paulo, Brazil

Dr. Saul Vizel Cardiac Research Office

🇨🇦

Cambridge, Ontario, Canada

Cornwall Clinical Trials

🇨🇦

Cornwall, Ontario, Canada

Dr. Gurcharan Syan (PP)

🇨🇦

Sudbury, Ontario, Canada

Hamilton Health Sciences - General Site

🇨🇦

Hamilton, Ontario, Canada

London Health Sciences Center

🇨🇦

London, Ontario, Canada

St. Michael's Hospital

🇨🇦

Toronto, Ontario, Canada

Ottawa Heart Institute

🇨🇦

Ottawa, Ontario, Canada

Service de la Recherche

🇨🇦

Granby, Quebec, Canada

Chum Hotel Dieu

🇨🇦

Montreal, Quebec, Canada

CSSS du Sud de Lanaudiere (Hopital Pierre-Le Gardeur)

🇨🇦

Terrebonne, Quebec, Canada

Misericordia Hospital - Cardiac Sciences

🇨🇦

Edmonton, Canada

CDRC Rive-Sud

🇨🇦

Longueuil, Canada

Saskatchewan Heart Centre

🇨🇦

Saskatoon, Canada

Cardiology Clinical Trials - Surrey Memorial Hospital

🇨🇦

Surrey, Canada

SMBD Jewish General Hospital

🇨🇦

Montreal, Canada

Centre Hospitalier de Trois-Rivieres

🇨🇦

Trois Rivieres, Canada

Cardio-Reanimation Centre

🇬🇪

Tbilisi, Georgia

National Center of Therapy

🇬🇪

Tbilisi, Georgia

Emergency Cardiology Centre

🇬🇪

Tbilisi, Georgia

Clinic of Angiocardiology "ADAPTI"

🇬🇪

Tbilisi, Georgia

Altay State Medical University of federal agency of public health and social progress RF

🇷🇺

Barnaul, Russian Federation

State Healthcare Institution "Region Clinical Hospital #1

🇷🇺

Krasnodar, Russian Federation

Research Institute of Physico-Chemical Medicine Center for Atheosclerosis and Laboratory

🇷🇺

Moscow, Russian Federation

Russian State Medical University, Hospital Therapy Department #1

🇷🇺

Moscow, Russian Federation

Federal State Institution "Outpatient clinic #3 of President's Management Department of Russian Fede

🇷🇺

Moscow, Russian Federation

Novosibirsk Municipal Clinical Emergency Hosp. # 2

🇷🇺

Novosibirsk, Russian Federation

Public Institution of Health City Hospital # 28

🇷🇺

Saint-Petersburg, Russian Federation

Saint-Petersburg State Health Institution "Pokrovskaya City Hospital"

🇷🇺

Saint-Petersburg, Russian Federation

State Educational Institution of High Professional Education Saratov State Medical University

🇷🇺

Saratov, Russian Federation

Federal State Institution

🇷🇺

Saratov, Russian Federation

Almasov research institute of Cardiology

🇷🇺

St. Petersberg, Russian Federation

Chair and Department of Hospital Therapy

🇷🇺

St. Petersburg, Russian Federation

State Health Care Institution "Voronezh Regional Clinical Consultative & Diagnostic Centre"

🇷🇺

Voronezh, Russian Federation

Yaroslavl Regional Clinical Hospital

🇷🇺

Yaroslavl, Russian Federation

City Healthcare Institution Clinical Hospital #8

🇷🇺

Yaroslavl, Russian Federation

State Institition Research Institution of Cardiology of Tomsk

🇷🇺

Tomsk, Russian Federation

State Educational institution of Higher Professional Education "Volgograd State Medical University o

🇷🇺

Volgograd, Russian Federation

Northwest Hospital

🇺🇸

Randallstown, Maryland, United States

Geisinger Medical Center

🇺🇸

Danville, Pennsylvania, United States

William Beaumont Health Center

🇺🇸

Royal Oak, Michigan, United States

New York Methodist Hospital

🇺🇸

Brooklyn, New York, United States

Lewin, Fagen, and Lown, MD, PC

🇺🇸

Smithtown, New York, United States

Oklahoma Heart Institute

🇺🇸

Tulsa, Oklahoma, United States

Durham VA Medical Center

🇺🇸

Durham, North Carolina, United States

Dallas VA Medical Center

🇺🇸

Dallas, Texas, United States

Associates in Cardiology, PA

🇺🇸

Silver Spring, Maryland, United States

Jamaica Hospital Medical Center

🇺🇸

Jamaica, New York, United States

Brevard Cardiovascular Research Associates, Inc

🇺🇸

Rockledge, Florida, United States

Thomas Jefferson University

🇺🇸

Philadelphia, Pennsylvania, United States

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