Effect of valsartan on quality of life when added to usual therapy for heart failure: Results from the Valsartan Heart Failure Trial

Background: The effect on quality of life (QOL) of valsartan administered in addition to prescribed background heart failure therapy was assessed as a secondary endpoint in the Valsartan Heart Failure Trial (Val-HeFT). Methods and Results: QOL was assessed in 3010 patients receiving either valsartan (160 mg twice daily) or placebo in addition to prescribed background therapy (β-blockers or angiotensin-converting enzyme inhibitors), using the Minnesota Living with Heart Failure (MLWHF) questionnaire. Treatment differences were compared at intervals to 36 months after randomization and at endpoint (last observation) using analysis of covariance and repeated measures mixed-effects, and at endpoint using a Mantel-Haenszel chi-squared test. Scores lower than baseline were indicative of improved QOL. Valsartan had a significant beneficial effect on the least-square mean change in overall MLWHF score from baseline to study endpoint (± standard error) (average followup 23.0 months) compared with placebo (0.19 ± 0.47 versus 1.94 ± 0.48; P = .005 respectively). The placebo group was characterized by a deterioration in QOL as the trial progressed. More patients on valsartan reported a clinically meaningful improvement in MLWHF score (a decrease of ≥5 points) than on placebo (34.0% versus 30.2%). Conclusion: Valsartan compared to placebo added to prescribed therapy slows progressive worsening of QOL in patients with heart failure.