Hemodynamic-GUIDEd Management of Heart Failure
- Conditions
- Heart Failure, SystolicHeart Failure NYHA Class IIHeart FailureHeart Failure, DiastolicHeart Failure NYHA Class IIIHeart Failure With Reduced Ejection FractionHeart Failure，CongestiveHeart Failure; With DecompensationHeart Failure NYHA Class IVHeart Failure With Normal Ejection Fraction
- Interventions
- Device: CardioMEMS™ HF System
- Registration Number
- NCT03387813
- Lead Sponsor
- Abbott Medical Devices
- Brief Summary
The GUIDE-HF IDE clinical trial is intended to demonstrate the effectiveness of the CardioMEMS™ HF System in an expanded patient population including heart failure (HF) patients outside of the present indication, but at risk for future HF events or mortality.
- Detailed Description
The GUIDE-HF IDE clinical trial is intended to demonstrate the effectiveness of the CardioMEMS™ HF System in an expanded patient population including HF patients outside of the present indication, but at risk for future HF events or mortality.
The trial includes patients with New York Heart Association (NYHA) Class II, III, or IV HF who have an elevated N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) (or an elevated Brain Natriuretic Peptide (BNP)) and/or a prior HF hospitalization (HFH).
The GUIDE-HF IDE trial will include approximately 3600 subjects at approximately 140 North American sites and consists of two arms: a Randomized Arm and a Single Arm.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2358
-
Diagnosis and treatment for heart failure (HF) (regardless of left ventricular ejection fraction (LVEF)) for > 90 days prior to the date of consent:
a. Subjects should be on stable, optimally titrated medical therapy for at least 30 days, as recommended according to current American Heart Association (AHA)/American College of Cardiology (ACC) guidelines as standard-of-care for HF therapy in the United States, with any intolerance documented.
-
GUIDE-HF Randomized Arm Only: NYHA Class II, III or IV HF symptoms documented within 30 days prior to consent.
-
GUIDE-HF Single Arm Only: NYHA Class III HF symptoms documented within 30 days prior to consent.
-
HF hospitalization (HFH) within 12 months prior to consent and/or elevated N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) (or Brain Natriuretic Peptide (BNP)) within 30 days prior to consent defined as:
- Subjects with LVEF ≤ 40%: NT-proBNP ≥ 1000 pg/mL (or BNP ≥ 250 pg/mL).
- Subjects with LVEF > 40%: NT-proBNP ≥ 700 pg/mL (or BNP ≥ 175 pg/mL).
- Thresholds for NT-proBNP and BNP (for both LVEF ≤ 40% and LVEF > 40%) will be corrected for body mass index (BMI) using a 4% reduction per BMI unit over 25 kg/m2
-
≥ 18 years of age
-
Chest circumference of < 65 inches, if BMI is > 35 kg/m2
-
Written informed consent obtained from subject
-
Willing and able to upload pulmonary artery (PA) pressure information and comply with the follow-up requirements
-
Intolerance to all neuro-hormonal antagonists (i.e., intolerance to angiotensin converting enzyme-inhibitors (ACE-I), angiotensin receptor blockers (ARB), angiotensin-neprilysin inhibitors (ARNi), hydralazine/isosorbide dinitrate and beta-blockers)
-
ACC/AHA Stage D refractory HF (including having received or currently receiving pharmacologic circulatory support with inotropes)
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Received or are likely to receive an advanced therapy (e.g., mechanical circulatory support or cardiac transplant) in the next 12 months
-
NYHA Class IV HF patients with:
- Continuous or chronic use of scheduled intermittent inotropic therapy for HF and an INTERMACS level of ≤ 4, OR
- Persistence of fluid overload with maximum (or dose equivalent) diuretic intervention
-
Glomerular Filtration Rate (eGFR) < 25 mL/min and non-responsive to diuretic therapy, or receiving chronic dialysis
-
Inability to tolerate or receive dual antiplatelet therapy or anticoagulation therapy for one month post-implantation
-
Significant congenital heart disease that has not been repaired and would prevent implantation of the CardioMEMS™ PA Sensor
-
Implanted with mechanical right heart valve(s)
-
Unrepaired severe valvular disease
-
Pregnant or planning to become pregnant in the next 12 months
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An active, ongoing infection, defined as being febrile, an elevated white blood cell count, on intravenous antibiotics, and/or positive cultures (blood, sputum or urine).
-
History of current or recurrent (≥ 2 episodes within 5 years prior to consent) pulmonary emboli and/or deep vein thrombosis
-
Major cardiovascular event (e.g., unstable angina, myocardial infarction, percutaneous coronary intervention, open heart surgery, or stroke, etc.) within 90 days prior to consent
-
Implanted with Cardiac Resynchronization Therapy (CRT)-Pacemaker (CRT-P) or CRT-Defibrillator (CRT-D) for less than 90 days prior to consent
-
Enrollment into another trial with an active treatment arm
-
Anticipated life expectancy of < 12 months
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Any condition that, in the opinion of the Investigator, would not allow for utilization of the CardioMEMS™ HF System to manage the subject using information gained from hemodynamic measurements to adjust medications, including the presence of unexpectedly severe pulmonary hypertension (e.g., trans-pulmonary gradient >15) at implant right heart catheterization (RHC), a history of non-compliance, or any condition that would preclude CardioMEMS™ PA Sensor implantation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Single Arm CardioMEMS™ HF System Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. Randomized Arm - Treatment Group CardioMEMS™ HF System Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. Randomized Arm - Control Group CardioMEMS™ HF System Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System.
- Primary Outcome Measures
Name Time Method (Randomized Arm) Composite outcome of (1) HFHs, (2) intravenous diuretic visits, and (3) all-cause mortality 12 months post-implantation The composite of:
1. The number of recurrent HFHs
2. The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy
3. The number of deaths of any cause
added together with equal weighting into a total number of events(Single Arm) Composite outcome of (1) HFHs, (2) intravenous diuretic visits, and (3) all-cause mortality 12 months post-implantation The composite outcome of:
1. The number of recurrent HFHs
2. The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy
3. The number of deaths of any cause
added together with equal weighting into a total number of events
- Secondary Outcome Measures
Name Time Method (Single Arm) HFHs post- vs. pre-implantation 12 months post-implantation The number of HFHs at 12 months post-implantation compared to the number of HFHs in the 12 months prior to implantation
(Randomized Arm) Composite outcome of (1) HFHs and (2) intravenous diuretic visits 12 months post-implantation The composite outcome of:
1. The number of recurrent HFHs
2. The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy
added together with equal weighting into a total number of events(Randomized Arm) EQ-5D-5L Baseline, 6, and 12 months post-implantation Health status as assessed by the EuroQol 5-Dimension, 5-Level (EQ-5D-5L) Questionnaire
(Randomized Arm) 6MHW Test Baseline, 6, and 12 months post-implantation Six Minute Hall Walk (6MHW) Test Distance
(Randomized Arm) Intravenous diuretic visits 12 months post-implantation The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy
(Randomized Arm) All-cause mortality 12 months post-implantation The number of deaths of any cause
(Single Arm) Intravenous diuretic visits 12 months post-implantation The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy
(Single Arm) All-cause mortality 12 months post-implantation The number of deaths of any cause
(Single Arm) Safety: Freedom from DSRCs 12 months post-implantation Freedom from DSRCs
(Randomized Arm) HFHs 12 months post-implantation The number of recurrent HFHs
(Single Arm) Composite outcome of (1) HFHs and (2) intravenous diuretic visits 12 months post-implantation The composite outcome of:
1. The number of recurrent HFHs
2. The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy
added together with equal weighting into a total number of events(Randomized Arm) KCCQ-12 Baseline, 6, and 12 months post-implantation Health status as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
(Randomized Arm) Safety: Freedom from DSRCs 12 months post-implantation Freedom from device/system related complications (DSRCs)
(Single Arm) HFHs 12 months post-implantation The number of HFHs
Trial Locations
- Locations (134)
Baylor University Hospital
🇺🇸Dallas, Texas, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Ronald Reagan UCLA Medical Center
🇺🇸Los Angeles, California, United States
The Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
John Muir Medical Center
🇺🇸Concord, California, United States
Memorial Hermann Hospital
🇺🇸Houston, Texas, United States
The Methodist Hospital
🇺🇸Houston, Texas, United States
University of Washington Medical Center
🇺🇸Seattle, Washington, United States
Providence Hospital
🇺🇸Southfield, Michigan, United States
Iowa Heart Center
🇺🇸West Des Moines, Iowa, United States
John Peter Smith Hospital
🇺🇸Fort Worth, Texas, United States
St. Francis Hospital
🇺🇸Roslyn, New York, United States
Akron City Hospital
🇺🇸Akron, Ohio, United States
San Diego Cardiac Center
🇺🇸San Diego, California, United States
Mercy Hospital
🇺🇸Miami, Florida, United States
St. Vincent Hospital
🇺🇸Indianapolis, Indiana, United States
Minneapolis Heart Institute
🇺🇸Minneapolis, Minnesota, United States
Kansas University Medical Center
🇺🇸Kansas City, Kansas, United States
Prisma Health-Midlands
🇺🇸Columbia, South Carolina, United States
Advocate Health and Hospitals Corporation
🇺🇸Oakbrook Terrace, Illinois, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
Lancaster General Hospital
🇺🇸Lancaster, Pennsylvania, United States
University of Arizona
🇺🇸Tucson, Arizona, United States
Abington Memorial Hospital
🇺🇸Abington, Pennsylvania, United States
Saint Barnabas Medical Center
🇺🇸Livingston, New Jersey, United States
North Colorado Medical Center
🇺🇸Greeley, Colorado, United States
Methodist Healthcare System of San Antonio
🇺🇸San Antonio, Texas, United States
Sentara Norfolk General Hospital
🇺🇸Norfolk, Virginia, United States
Waukesha Memorial Hospital
🇺🇸Waukesha, Wisconsin, United States
Vancouver General Hospital (U of BC)
🇨🇦Vancouver, British Columbia, Canada
Swedish Medical Center - Heart & Vascular
🇺🇸Seattle, Washington, United States
Virginia Heart - The Cardiovascular Group, P.C.
🇺🇸Falls Church, Virginia, United States
Winchester Medical Center
🇺🇸Winchester, Virginia, United States
Providence Everett Medical Center
🇺🇸Everett, Washington, United States
Foothills Medical Centre
🇨🇦Calgary, Alberta, Canada
Southlake Regional Health Centre
🇨🇦Newmarket, Ontario, Canada
Toronto General Hospital
🇨🇦Toronto, Ontario, Canada
Banner-University Medical Center Phoenix
🇺🇸Phoenix, Arizona, United States
Phoenix Cardiovascular Research Group
🇺🇸Phoenix, Arizona, United States
California Pacific Medical Center - Van Ness Campus
🇺🇸San Francisco, California, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Integris Baptist Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
Oklahoma Heart Hospital South
🇺🇸Oklahoma City, Oklahoma, United States
Providence Heart and Vascular
🇺🇸Portland, Oregon, United States
Aurora Medical Group
🇺🇸Milwaukee, Wisconsin, United States
University of Colorado Hospital
🇺🇸Aurora, Colorado, United States
Arizona Cardiovascular Research Center
🇺🇸Phoenix, Arizona, United States
Baptist Health Medical Center
🇺🇸Little Rock, Arkansas, United States
Washington Regional Medical Center
🇺🇸Fayetteville, Arkansas, United States
Arkansas Heart Hospital
🇺🇸Little Rock, Arkansas, United States
USC University Hospital
🇺🇸Los Angeles, California, United States
University of California at San Diego (UCSD) Medical Center
🇺🇸La Jolla, California, United States
Scripps Health
🇺🇸La Jolla, California, United States
Adventist Health St. Helena
🇺🇸Deer Park, California, United States
Ventura Cardiology Consultants
🇺🇸Ventura, California, United States
South Denver Cardiology Associates PC
🇺🇸Littleton, Colorado, United States
George Washington University Hospital
🇺🇸Washington, District of Columbia, United States
Bethesda Memorial Hospital
🇺🇸Boynton Beach, Florida, United States
Morton Plant Hospital
🇺🇸Clearwater, Florida, United States
Memorial Regional Hospital
🇺🇸Hollywood, Florida, United States
Tampa General Hospital
🇺🇸Tampa, Florida, United States
First Coast Cardiovascular Institute
🇺🇸Jacksonville, Florida, United States
Memorial Hospital Jacksonville
🇺🇸Jacksonville, Florida, United States
Piedmont Athens Regional Medical Center
🇺🇸Athens, Georgia, United States
University Hospital
🇺🇸Augusta, Georgia, United States
Northshore University HealthSystem
🇺🇸Evanston, Illinois, United States
Midwest Cardiovascular Institute
🇺🇸Naperville, Illinois, United States
Cardiovascular Research Institute of Kansas
🇺🇸Wichita, Kansas, United States
Cardiovascular Institute of the South
🇺🇸Houma, Louisiana, United States
Advanced Cardiovascular Specialists
🇺🇸Shreveport, Louisiana, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
University of Massachusetts
🇺🇸Worcester, Massachusetts, United States
MidMichigan Medical Center-Midland
🇺🇸Midland, Michigan, United States
McLaren Health Care Corporation
🇺🇸Auburn Hills, Michigan, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
University of Minnesota Medical Center Fairview
🇺🇸Minneapolis, Minnesota, United States
North Kansas City Hospital
🇺🇸North Kansas City, Missouri, United States
St. Cloud Hospital
🇺🇸Saint Cloud, Minnesota, United States
Mercy Hospital St. Louis
🇺🇸Saint Louis, Missouri, United States
BryanLGH Heart Institute
🇺🇸Lincoln, Nebraska, United States
Renown Regional Medical Center
🇺🇸Reno, Nevada, United States
Catholic Medical Center
🇺🇸Manchester, New Hampshire, United States
Lourdes Cardiology Services
🇺🇸Voorhees, New Jersey, United States
New York University Hospital
🇺🇸New York, New York, United States
Mount Sinai Hospital
🇺🇸New York, New York, United States
New York-Presbyterian/Columbia University
🇺🇸New York, New York, United States
Hudson Valley Cardiovascular Practice, P.C.
🇺🇸Poughkeepsie, New York, United States
Rochester General Hospital
🇺🇸Rochester, New York, United States
Vidant Medical Center
🇺🇸Greenville, North Carolina, United States
WakeMed Hospital
🇺🇸Raleigh, North Carolina, United States
Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
Ohio Health Research Institute
🇺🇸Columbus, Ohio, United States
St. Elizabeth Health Center
🇺🇸Youngstown, Ohio, United States
Tennova Healthcare - Turkey Creek Medical Center
🇺🇸Knoxville, Tennessee, United States
Pinnacle Health System
🇺🇸Harrisburg, Pennsylvania, United States
Albert Einstein Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
The Reading Hospital and Medical Center
🇺🇸West Reading, Pennsylvania, United States
Main Line Health Center/Lankenau Hospital
🇺🇸Wynnewood, Pennsylvania, United States
Methodist University Hospital
🇺🇸Memphis, Tennessee, United States
Allegheny General Hospital - ASRI
🇺🇸Pittsburgh, Pennsylvania, United States
Greenville Health System
🇺🇸Greenville, South Carolina, United States
Sanford USD Medical Center
🇺🇸Sioux Falls, South Dakota, United States
St Thomas Hospital
🇺🇸Nashville, Tennessee, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
CHI St. Luke's Health Baylor College of Medicine Med. Ctr.
🇺🇸Houston, Texas, United States
Park Plaza Hospital
🇺🇸Houston, Texas, United States
Sparrow Clinical Research Institute
🇺🇸Lansing, Michigan, United States
Eisenhower Medical Center
🇺🇸Rancho Mirage, California, United States
WellStar Kennestone Hospital
🇺🇸Marietta, Georgia, United States
Heart Center of Lake County
🇺🇸Merrillville, Indiana, United States
Aspirus Wausau Hospital
🇺🇸Wausau, Wisconsin, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Our Lady of the Lake Hospital
🇺🇸Baton Rouge, Louisiana, United States
Deborah Heart and Lung Center
🇺🇸Browns Mills, New Jersey, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
NC Heart and Vascular Research
🇺🇸Raleigh, North Carolina, United States
Oklahoma Heart Institute at Utica
🇺🇸Tulsa, Oklahoma, United States
Penn State Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Sutter Medical Center, Sacramento
🇺🇸Sacramento, California, United States
Mercy Medical Group - Cardiology
🇺🇸Sacramento, California, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
St. Luke's Hospital
🇺🇸Kansas City, Missouri, United States
Yale New Haven Hospital
🇺🇸New Haven, Connecticut, United States
Advent Health Orlando
🇺🇸Orlando, Florida, United States
Orlando Regional Medical Center
🇺🇸Orlando, Florida, United States
Louisiana State University Health Sciences Center
🇺🇸New Orleans, Louisiana, United States
Ochsner Medical Center
🇺🇸New Orleans, Louisiana, United States
Acension Texas Cardiovascular
🇺🇸Austin, Texas, United States
Austin Heart
🇺🇸Austin, Texas, United States
Bon Secours Heart & Vascular Institute
🇺🇸Richmond, Virginia, United States
New Mexico Heart Institute
🇺🇸Albuquerque, New Mexico, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States