Clinical Trial: Supramaximal Titrated Inhibition of RAAS in Dilated Cardiomyopathy
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Efficacy and Safety Study of Supramaximal Titrated Inhibition of RAAS in Idiopathic Dilated Cardiomyopathy
Brief 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.
Detailed Summary:
Sponsor: Xijing Hospital
Current Primary Outcome: All cause death or admission for heart failure [ Time Frame: 48 months after enrollment ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Changes in NYHA functional class [ Time Frame: 6,12, 24 and 36 months after enrollment ]
- Left-ventricular ejection fraction [ Time Frame: 6,12, 24 and 36 months after enrollment ]Left ventricular ejection fraction (LVEF) were calculated from measurements of left ventricular end diastolic and end systolic volumes in apical 4 and 2 chamber views using the modified Simpson's rule according to current guidelines
- Left-ventricular end-diastolic diameter [ Time Frame: 6, 12 , 24 and 36 months after enrollment ]
Original Secondary Outcome: Same as current
Information By: Xijing Hospital
Dates:
Date Received: July 30, 2013
Date Started: March 2005
Date Completion:
Last Updated: May 16, 2014
Last Verified: May 2014