A Study to Compare the Effects of Coreg CR and Coreg IR on Heart Function in Subjects With Stable Chronic Heart Failure
Condition: Congestive Heart Failure
MeSH terms: Heart Failure
Intervention: carvedilol controlled release; carvedilol immediate release
Intervention description: Carvedilol controlled release (10, 20, 40 or 80 mg) and placebo taken in the morning. Two placebos taken in the evening. A total of 4 pills will be taken PO daily.; Carvedilol immediate release (3.125, 6.25, 12.5 or 25 mg) and placebo, taken PO, twice-daily.
Intervention MeSH terms: Carvedilol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 318.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: heart failure

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.
    

Eligibility 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.