Valsartan in Systemic RV

Circulation. 2013; 127: 322-330
Effect of Valsartan on Systemic Right Ventricular Function

A Double-Blind, Randomized, Placebo-Controlled Pilot Trial

Teun van der Bom, MD et al. Netherland.
Methods and Results—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 MRI or CT. 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="" 2="" 95="" and="" confidence="" g="" group.="" group="" in="" interval="" mass="" p="0.01)" placebo="" than="" the="" valsartan="">
Conclusions—There was no significant treatment effect of valsartan on right ventricular ejection fraction, exercise capacity, or quality of life. Small but significant differences between valsartan and placebo were present for change in right ventricular volumes and mass.