Problem Heart failure (NYHA II-IV)
Format Multicenter, double-blinded, parallel-group, randomized, placebo-controlled trial
Treatment Valsartan
Control Placebo
Population 5010 patients
Inclusion criteria Age >18 years
History and exam findings of CHF >3 months prior to screening
NYHA class II-IV with compensated heart failure
Receipt of medical therapy for >2 weeks prior
EF <40% and LV dilatation
Exclusion criteria Pregnancy, nursing mothers, or women of child-bearing potential not using contraception, postpartum cardiomyopathy
Cor pulmonale
Decompensated CHF
Cardiac surgery or PCTA within past 3 months
History of heart transplant or listed for heart transplant
CAD likely to require intervention
Sustained VT with syncope within past 3 months
Hemodynamically significant valvular disease
Hypertrophic cardiomyopathy
Stroke within 3 months
Clinically significant renal failure (Cr >2.5), hepatic failure, or hematologic disorder
Malignancies limiting 5 year survival
<5 year life expectancy
Contraindication to ARBs
Prior double-blind treatment in a valsartan CHF trial
Any investigational drug trial within 30 days
Treatment with class 1C agents, IV inotropes or vasodilators, or AII antagonists in past 3 months.
Follow-up Mean 23 months
Primary endpoint All-cause mortality
Secondary endpoint(s) Combined endpoint of mortality and morbidity
Details -
Brief summary: Valsartan improved symptoms & mortality in NYHA2+; no benefit added to ACEi
PAPER: A randomized trial of the angiotensin-receptor blocker valsartan in chronic heart failure.
Date 6 Dec 2001
Journal N Engl J Med. 2001 Dec 6;345(23):1667-75.
Information Significantly
-Reduced mortality and morbidity
-Improved signs and symptoms
Adverse effects for those Valsartan, ACEi and Beta-blocker
-Increased mortality and morbidity