The Effect of Valsartan on the Systemic Right Ventricular Function: A Double-Blind Randomized Placebo-Controlled Pilot Trial
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 160mg twice daily compared with placebo in patients with a systemic right ventricle due to congenitally or surgically corrected transposition of the great arteries. The primary endpoint was change in right ventricular ejection fraction during three year follow-up, determined by cardiovascular magnetic resonance imaging or in patients with contraindication for MRI multirow detector computed tomography. Secondary endpoints were change in right ventricular volumes and mass, and V'O2 peak, and quality of life. Primary analyses were done by intention-to-treat. 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 three year valsartan therapy on systemic right ventricular ejection fraction (treatment effect 1.3%, 95%CI -1.3 to 3.9; p=0.34), maximum exercise capacity, and quality of life. There was a larger increase in right ventricular end-diastolic volume (15ml, 95%CI 3ml to 28ml, p<0.01) and mass (8g 95%CI 2g to 14g, 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 compared with placebo. Small but significant differences between valsartan and placebo were present for change in right ventricular volumes and mass.
Clinical Trial Registration Information—http://www.controlled-trials.com; Identifier: ISRCTN52352170.
- adult congenital heart disease
- magnetic resonance imaging
- renin angiotensin system
- transposition of great vessels
- angiotensin II receptor blocker
- Received August 13, 2012.
- Accepted November 19, 2012.
- Copyright © 2012, American Heart Association, Inc. All rights reserved. Unauthorized use prohibited