A randomized, double-blind, placebo-controlled study to determine the effects of valsartan on exercise time in patients with symptomatic heart failure with preserved ejection fraction
1 Department of Cardiology, Papworth Hospital, Cambridge CB23 3RE, UK
2 Department of Cardiology, University of Goettingen, Goettingen, Germany
3 Department of Cardiology, Medical University of Graz, Auenbruggerplatz 15, 8036 Graz, Austria
4 Novartis Pharma AG, Fabrikstrasse 4, CH-4056 Basel, Switzerland
5 Medical Department, Novartis Pharmaceuticals UK Ltd, Frimley Business Park, Camberley, Surrey GU16 7SR, UK
6 Division of Medicine and Therapeutics, Ninewells Hospital and Medical School, University of Dundee, Dundee DD1 9SY, UK
* Corresponding author. Tel: +44 1382 632575, Fax: +44 1382 642637, Email: tom{at}memo.dundee.ac.uk
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Abstract |
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Aims: To determine whether valsartan improves treadmill exercise time, in patients with symptomatic heart failure with a preserved ejection fraction (HFPEF), compared with placebo.
Methods and results: In this multicentred, double-blind, 14-week study, patients were randomized to receive valsartan (V) 80 mg or placebo (P) once daily on top of background medications. The dose of valsartan was force-titrated up to 320 mg. A total of 152 patients were randomized (V = 70, P = 82). Most patients had well-controlled hypertension (V = 91.2%, P = 89.0%) (mean baseline systolic BP 
130 mmHg) and >50% were receiving an angiotensin-converting enzyme inhibitor and/or beta-blocker (V = 57.4%, P = 54.9%). The mean ejection fraction at baseline was 70.48% in the placebo group (n = 64) and 71.52% in the valsartan group (n = 79). Valsartan had no significant effect on exercise time (primary variable), gas exchange variables, 6 min walk test distance, exertion-related symptoms, brain natriuretic peptide levels, echocardiographic parameters, or quality-of-life scores. Valsartan significantly lowered peak exercise systolic BP (–13.1 mmHg vs. placebo; P < 0.001) and improved ratings of perceived exertion (Borg score) (–0.69 vs. placebo; P = 0.008).
Conclusion: In this population, which predominantly included patients with well-controlled hypertension and symptomatic HFPEF, addition of valsartan did not increase exercise time within 14 weeks. However, valsartan 320 mg reduced blood pressure and improved symptoms of perceived exertion (Borg score) during exercise and was generally well-tolerated.
Key Words: Heart failure with preserved ejection fraction • Echocardiography • Exercise time • Placebo • Quality of life • Valsartan
Received June 4, 2009; Revised July 12, 2009; Accepted July 23, 2009
These authors contributed equally to the work.