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)
The Heart Group
🇺🇸Mobile, Alabama, United States
Radiant Research
🇺🇸Santa Rosa, California, United States
Cardiology Consultants of Orange County
🇺🇸Anaheim, California, United States
Access Clinical Trials
🇺🇸Beverly Hills, California, United States
Cardiovascular Consultants Medical Group
🇺🇸Walnut Creek, California, United States
San Diego Cardiac Center
🇺🇸San Diego, California, United States
Northern California Medical Associates
🇺🇸Santa Rosa, California, United States
Heart Center of the Rockies
🇺🇸Fort Collins, Colorado, United States
St. Francis Hospital and Medical Center
🇺🇸Hartford, Connecticut, United States
NextPhase Clinical Trials
🇺🇸Miami, Florida, United States
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