Supramaximal Titrated Inhibition of RAAS in Dilated Cardiomyopathy
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | — |