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ValHeFT TRIAL |
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| 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 ACS 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 Noncompliance 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 |