drugset / Trial / NCT01917149

Supramaximal Titrated Inhibition of RAAS in Dilated Cardiomyopathy

NCT01917149

Phase 4 Completed 480 enrolled Xijing Hospital
RandomizedParallel-groupSingle-blindTreatment

Summary

Dilated cardiomyopathy (DCM) is a poorly understood cause of systolic heart failure and is the most common indication for heart transplantation worldwide. Despite advances in medical and device therapy, the 5-year mortality of patients with DCM remains high. Patients diagnosed of dilated cardiomyopathy with a NYHA functional class of II to IV and left ventricular ejection fraction(LVEF) \<35% were selected for randomized controlled study of the efficacy and safety of high dose Renin-angiotensin system (RAS) inhibitor (benazepril or valsartan), in comparison with low dose RAS inhibitor(benazepril or valsartan) and standard beta-adrenergic blocker therapy (metoprolol). The primary endpoint was all cause death or admission for heart failure. Additional prespecified outcomes included all-cause death, cardiovascular death, all-cause admission, heart failure admission. Secondary cardiovascular outcomes included the changes from baseline to the last available observation after treatment in NYHA functional class, quality-of-life scores, LVEF, LVEDD, mitral regurgitation and wall-motion score index assessed by ECG. Adverse events were reported during in-hospital observation and follow-ups.

Timeline

Start
2005-03
Primary completion
2013-07
Completion
2013-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Benazepril Unknown 10 mg
Subject Benazepril Unknown 40 mg
Subject Benazepril Unknown 60 mg
Subject Benazepril Unknown 80 mg
Subject Metoprolol Other / unclassified 190 mg
Subject Valsartan Small molecule 80 mg
Subject Valsartan Small molecule 320 mg
Subject Valsartan Small molecule 480 mg
Subject Valsartan Small molecule 640 mg