Effect of Valsartan on Systemic Right Ventricular Function

Author:

van der Bom Teun1,Winter Michiel M.1,Bouma Berto J.1,Groenink Maarten1,Vliegen Hubert W.1,Pieper Petronella G.1,van Dijk Arie P.J.1,Sieswerda Gertjan T.1,Roos-Hesselink Jolien W.1,Zwinderman Aeilko H.1,Mulder Barbara J.M.1

Affiliation:

1. From the Department of Cardiology (T.v.d.B., M.M.W., B.J.B., M.G., B.J.M.M.), Department of Radiology (M.G.), and Department of Clinical Epidemiology and Biostatistics (A.H.Z.), Academic Medical Center, Amsterdam, Netherlands The Netherlands Heart Institute, Utrecht, Netherlands (T.v.d.B., M.M.W., B.J.M.M.); Department of Cardiology, Leiden University Medical Center, Leiden, Netherlands (H.W.V.); Department of Cardiology, University Medical Center Groningen, Groningen, Netherlands (P.G.P.);...

Abstract

Background— The role of angiotensin II receptor blockers in patients with a systemic right ventricle has not been elucidated. Methods and Results— We conducted a multicenter, double-blind, parallel, randomized controlled trial of angiotensin II receptor blocker valsartan 160 mg twice daily compared with placebo in patients with a systemic right ventricle caused by congenitally or surgically corrected transposition of the great arteries. The primary end point was change in right ventricular ejection fraction during 3-year follow-up, determined by cardiovascular magnetic resonance imaging or, in patients with contraindication for magnetic resonance imaging, multirow detector computed tomography. Secondary end points were change in right ventricular volumes and mass, peak, and quality of life. Primary analyses were performed on an intention-to-treat basis. A total of 88 patients (valsartan, n=44; placebo, n=44) were enrolled in the trial. No serious adverse effects occurred in either group. There was no significant effect of 3-year valsartan therapy on systemic right ventricular ejection fraction (treatment effect, 1.3%; 95% confidence interval, −1.3% to 3.9%; P =0.34), maximum exercise capacity, or quality of life. There was a larger increase in right ventricular end-diastolic volume (15 mL; 95% confidence interval, 3–28 mL; P <0.01) and mass (8 g; 95% confidence interval, 2–14 g; P =0.01) in the placebo group than in the valsartan group. Conclusions— There was no significant treatment effect of valsartan on right ventricular ejection fraction, exercise capacity, or quality of life. Valsartan was associated with a similar frequency of significant clinical events as placebo. Small but significant differences between valsartan and placebo were present for change in right ventricular volumes and mass. Clinical Trial Registration— URL: http://www.controlled-trials.com . Unique identifier: ISRCTN52352170.

Publisher

Ovid Technologies (Wolters Kluwer Health)

Subject

Physiology (medical),Cardiology and Cardiovascular Medicine

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