A Study to Compare the Effects of Coreg CR and Coreg IR on Heart Function in Subjects With Stable Chronic Heart Failure

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CTI-1, LLC
• Collaborators: CTI Clinical Trial and Consulting Services; GlaxoSmithKline
• Treatments: Carvedilol

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.