A Study to Compare the Effects of Coreg CR and Coreg IR on Heart Function in Subjects With Stable⦠(NCT00323037) | Clinical Trial Compass
CompletedPhase 3
A Study to Compare the Effects of Coreg CR and Coreg IR on Heart Function in Subjects With Stable Chronic Heart Failure
United States318 participantsStarted 2006-03
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 blockersā¦
What they're measuring
1
Change From Baseline in Left Ventricular End Systolic Volume Index (LVESVI) Characterized by 2-D Echocardiography
Timeframe: 24 weeks after entry into the maintenance period