Drug Compliance and Quality of Life in Patients With Heart Failure Dosed With Either Once-daily or Twice-daily Coreg
- Conditions
- Chronic Heart Failure
- Registration Number
- NCT00272805
- Lead Sponsor
- Cardiovascular Clinical Studies
- Brief Summary
The purpose of this study is to compare dosing compliance between study patients taking controlled release carvedilol once a day, and study patients taking immediate release carvedilol (Coreg) twice a day.
- Detailed Description
Study Further Study Details:
Primary outcome: pill-taking compliance (total doses taken versus total doses prescribed)
Expected Total Enrollment: 400 subjects at 56 study sites in the U.S.
Study Start: October 2005
This is a 5-month double-blind treatment study of male and female subjects with stable mild-to-severe chronic heart failure and with left ventricular dysfunction with symptoms of heart failure.
Eligibility:
Must be stable on treatment with Coreg IR at a standard dose: 6.25, 12.5, 25 mg twice a day.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 400
- Ability to read English
- Stable symptoms of mild to severe heart failure
- Stable medical regimen for heart failure
- On a stable dose of Coreg for at least 2 months
- LVEF ≤40% within the previous 24 months
- Uncorrected obstructive or regurgitant valve disease
- Complex congenital heart disease
- Recent ICD or pacemaker placement
- Recent coronary artery bypass surgery or stroke
- Candidate for heart transplanct within 5 months of study start
- Present or planned use of MAO inhibitors, alfpha-blockers, combined alpha-beta blockers, any Class I/II anti-arrythmnic agents, (amiodarone may be used if ≤ 200mg/day). Use of intravenous vasodilator/inotropic agents.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Dosing compliance: pill taking total taken vs number prescribed
- Secondary Outcome Measures
Name Time Method quality of life
Trial Locations
- Locations (51)
Idaho Cardiology Associates
🇺🇸Boise, Idaho, United States
St. Francis Hospital and Medical Center
🇺🇸Hartford, Connecticut, United States
Charlotte Heart Group Research Center
🇺🇸Port Charlotte, Florida, United States
CVMS Research Institute of Augusta
🇺🇸Augusta, Georgia, United States
Cardiovascular Consultants of Maine
🇺🇸Scarborough, Maine, United States
The Heart and Vascular Institute of Florida
🇺🇸St. Petersburg, Florida, United States
Cardiac Disease Specialists
🇺🇸Atlanta, Georgia, United States
Pentucket Medical Associates
🇺🇸Haverhill, Massachusetts, United States
Associated Cardiovascular Consultants
🇺🇸Cherry Hill, New Jersey, United States
South Bay Cardiovascular Associates
🇺🇸West Islip, New York, United States
New York University Medical School
🇺🇸New York, New York, United States
Lahey Clinic Cardiology
🇺🇸Burlington, Massachusetts, United States
Bryan LGH Heart Institute
🇺🇸Lincoln, Nebraska, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Albany Associates in Cardiology
🇺🇸Albany, New York, United States
Akron General Medical Center
🇺🇸Akron, Ohio, United States
The Care Group
🇺🇸Indianapolis, Indiana, United States
NextPhase Clinical Trials
🇺🇸Miami, Florida, United States
San Diego Cardiac Center
🇺🇸San Diego, California, United States
Lovelace Scientific Resources
🇺🇸Las Vegas, Nevada, United States
The Lindner Clinical Trial Center
🇺🇸Cincinnati, Ohio, United States
New Horizons Clinical Research
🇺🇸Cincinnati, Ohio, United States
Cardiovascular Consultants of Oregon
🇺🇸Corvallis, Oregon, United States
The Heart Group
🇺🇸Mobile, Alabama, United States
Cardiology Consultants of Orange County
🇺🇸Anaheim, California, United States
Cardiovascular Consultants Medical Group
🇺🇸Walnut Creek, California, United States
Access Clinical Trials
🇺🇸Beverly Hills, California, United States
Northern California Medical Associates
🇺🇸Santa Rosa, California, United States
Heart Center of the Rockies
🇺🇸Fort Collins, Colorado, United States
Georgia Heart Specialists
🇺🇸Covington, Georgia, United States
Androscoggin Cardiology Associates-Research
🇺🇸Auburn, Maine, United States
Illinois Heart and Lung Research Center
🇺🇸Normal, Illinois, United States
North Shore Cardiologists
🇺🇸Bannockburn, Illinois, United States
Maine Cardiology Associates
🇺🇸S.Portland, Maine, United States
Midwest Heart Foundation
🇺🇸Lombard, Illinois, United States
Clinical Trials Management
🇺🇸Metairie, Louisiana, United States
Primary Care Cardiology Research
🇺🇸Ayer, Massachusetts, United States
MidValley Cardiology
🇺🇸Kingston, New York, United States
University of New Mexico Health Science Center
🇺🇸Albuquerque, New Mexico, United States
Cardiovascular Medical Associates
🇺🇸Garden City, New York, United States
Alamance Regional Medical Center
🇺🇸Burlington, North Carolina, United States
North Ohio Research Ltd.
🇺🇸Sandusky, Ohio, United States
The Dayton Heart Center
🇺🇸Dayton, Ohio, United States
Blue Stem Cardiology
🇺🇸Bartlesville, Oklahoma, United States
Oregon Medical Group Clinical Research
🇺🇸Eugene, Oregon, United States
Guthrie Clinic Ltd.
🇺🇸Sayre, Pennsylvania, United States
Rhode Island Heart Failure Center
🇺🇸Providence, Rhode Island, United States
Arrythmia Center for Southern Wisconsin
🇺🇸Elkhorn, Wisconsin, United States
LDS Hospital Cardiovascular Research
🇺🇸Salt Lake City, Utah, United States
DCOL Center for Clinical Research
🇺🇸Longview, Texas, United States
Radiant Research
🇺🇸Santa Rosa, California, United States