Status:
COMPLETED
A Study to Compare the Effects of Coreg CR and Coreg IR on Heart Function in Subjects With Stable Chronic Heart Failure
Lead Sponsor:
CTI-1, LLC
Collaborating Sponsors:
CTI Clinical Trial and Consulting Services
GlaxoSmithKline
Conditions:
Congestive Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine if Coreg CR is as effective as Coreg IR in improving heart function in subjects with stable chronic heart failure.
Detailed Description
Results of clinical trials have shown beta-blockers improve symptoms and left ventricular function, reduce hospitalizations and death in heart failure, and prolong survival \[MERIT-HF, CIBIS-II, Packe...
Eligibility Criteria
Inclusion
- Male or non-pregnant female
- At least 18 years of age at the time informed consent is signed
- Stable, chronic, mild to severe heart failure as defined as subjects with symptoms of heart failure who do not require IV diuretics, inotropes, or vasodilators or those that require support with a left ventricular assist device
- Angiotensin converting enzyme inhibitors or angiotensin receptor blockers should be prescribed to all patients with HF due to LV systolic dysfunction with reduced LVEF unless contraindicated or intolerant to use
- At screening, subject has an LVEF \< 40 as measured by 2-D echocardiography
- Willing to provide written informed consent
Exclusion
- On beta-blocker therapy for greater than 42 days prior to consent
- Acute ischemic coronary event or coronary revascularization (PTCA, CABG, thrombolysis) within 1 week of screening echocardiography
- Scheduled or expected to be scheduled coronary revascularization within 4 weeks
- Unstable angina (angina characterized by sudden changes in the severity or length of angina attacks or a decrease in level of exertion that precipitates an episode
- Uncorrected primary obstructive or severe regurgitant valvular disease, nondilated (restrictive) or hypertrophic cardiomyopathies
- Uncontrolled ventricular arrhythmias (symptomatic or sustained ventricular arrhythmias not controlled with antiarrhythmic therapy or an implantable defibrillator)
- Current treatment of calcium channel blockers except for long acting dihydropyridines
- Current treatment on any Class I or III antiarrhythmic, except amiodarone
- History of sick sinus syndrome unless a pacemaker is in place
- Second or third degree heart block unless a pacemaker is in place
- Current clinical evidence of obstructive pulmonary disease (e.g., asthma or bronchitis) requiring inhaled or oral bronchodilator or steroid therapy; or having a history of bronchospastic disease not undergoing active therapy in whom, in the investigator's opinion, treatment with study medication could provoke bronchospasm
- Expected biventricular pacemaker placement within 8 months of enrollment
- Resting systolic blood pressure \<90 mmHg (based on the average of 3 readings
- Resting heart rate \<50 beats per minute (bpm) (based on the average of 3 readings)
- Current decompensated heart failure
- Elevated liver enzymes (i.e., ALT or AST levels greater than 3 times upper limit of normal)
- History of drug sensitivity or allergic reaction to alpha or beta-blockers
- Contraindication or intolerance to beta-blockers
- Pregnant or lactating women and women planning to become pregnant. NOTE: Female subjects must be post-menopausal (i.e., no menstrual period for a minimum of 6 months prior to screening), surgically sterilized, using a double barrier method contraceptive, or using Depo-Provera or implanted contraceptives for at least one month prior to screening and agree to continue to use the same contraceptive method throughout the study.
- Use of an investigational drug within 30 days of enrollment
- Participation in an investigational device trial within 30 days of enrollment
- Known drug or alcohol abuse 1 year prior to enrollment
- In the opinion of the investigator the subject is known to be noncompliant with prescribed medication regimen
- Has any systemic disease, including cancer, with reduced life expectancy (\<12 months)
- Has a history of psychological illness/condition that interferes with ability to understand or complete requirements of the study.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
318 Patients enrolled
Trial Details
Trial ID
NCT00323037
Start Date
March 1 2006
End Date
June 1 2008
Last Update
March 28 2023
Active Locations (75)
Enter a location and click search to find clinical trials sorted by distance.
1
Cardiology Associates
Mobile, Alabama, United States, 36608
2
Mobile Heart Specialists
Mobile, Alabama, United States, 36608
3
Mayo Clinic Arizona
Phoenix, Arizona, United States, 85054
4
Scottsdale Cardiovascular Research Institute
Scottsdale, Arizona, United States, 85251