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 ]

Admission for heart failure was defined as a minimum of 24 h inpatient admission to any health-care facility, with the primary cause being treated for worsening heart failure and during which an additional diuretic drug, intravenous or oral nitrate, or intravenous inotropic agent was given.


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