Supramaximal Titrated Inhibition of RAAS in Dilated Cardiomyopathy
Status:
Completed
Trial end date:
2013-12-01
Target enrollment:
Participant gender:
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.