Rationale and design of a trial on the effect of angiotensin II receptor blockers on the function of the systemic right ventricle

Am Heart J. 2010 Nov;160(5):812-8. doi: 10.1016/j.ahj.2010.08.005.

Abstract

Background: Angiotensin II receptor blockers have been proven to be beneficial in left ventricular failure. In patients with a morphologic right ventricle supporting the systemic circulation, its efficacy has not yet been established.

Methods: We designed a multicenter, prospective, randomized, double-blind, placebo-controlled trial studying the effect of valsartan in patients with a systemic right ventricle due to a congenitally or surgically corrected transposition of the great arteries. The primary end point is the change in right ventricular ejection fraction as measured by cardiovascular magnetic resonance or multidetector row cardiac computed tomography in case of pacemaker patients.

Conclusion: This large prospective, double-blind, randomized, placebo-controlled trial will establish the role of angiotensin II receptor blockers (valsartan) in the treatment of patients with a systemic right ventricle.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Angiotensin II Type 1 Receptor Blockers / administration & dosage*
  • Double-Blind Method
  • Female
  • Follow-Up Studies
  • Heart Atria / abnormalities*
  • Heart Atria / drug effects
  • Heart Atria / physiopathology
  • Humans
  • Magnetic Resonance Imaging
  • Male
  • Prospective Studies
  • Stroke Volume / drug effects*
  • Tetrazoles / administration & dosage*
  • Tomography, X-Ray Computed
  • Treatment Outcome
  • Valine / administration & dosage
  • Valine / analogs & derivatives*
  • Valsartan
  • Ventricular Dysfunction, Right / congenital
  • Ventricular Dysfunction, Right / drug therapy*
  • Ventricular Dysfunction, Right / physiopathology
  • Ventricular Function, Right / drug effects*

Substances

  • Angiotensin II Type 1 Receptor Blockers
  • Tetrazoles
  • Valsartan
  • Valine

Associated data

  • ISRCTN/ISRCTN52352170