title: Effect of valsartan on systemic right ventricular function: a double-blind, randomized, placebo-controlled pilot trial.
abstract: BACKGROUND
  The role of angiotensin II receptor blockers in patients with a systemic right ventricle has not been elucidated.
  
  
  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, Vo(2)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.
  
  
  BACKGROUND
  URL: http://www.controlled-trials.com. Unique identifier: ISRCTN52352170.
authors.affiliation: Department of Cardiology, Academic Medical Center, Amsterdam, Netherlands.
authors.forename: Teun
authors.initials: T
authors.lastname: van der Bom
authors.forename: Michiel M
authors.initials: MM
authors.lastname: Winter
authors.forename: Berto J
authors.initials: BJ
authors.lastname: Bouma
authors.forename: Maarten
authors.initials: M
authors.lastname: Groenink
authors.forename: Hubert W
authors.initials: HW
authors.lastname: Vliegen
authors.forename: Petronella G
authors.initials: PG
authors.lastname: Pieper
authors.forename: Arie P J
authors.initials: AP
authors.lastname: van Dijk
authors.forename: Gertjan T
authors.initials: GT
authors.lastname: Sieswerda
authors.forename: Jolien W
authors.initials: JW
authors.lastname: Roos-Hesselink
authors.forename: Aeilko H
authors.initials: AH
authors.lastname: Zwinderman
authors.forename: Barbara J M
authors.initials: BJ
authors.lastname: Mulder
mesh_terms: D000328:Adult; D047228:Angiotensin II Type 1 Receptor Blockers / Q000009:adverse effects / Q000494:pharmacology* / Q000627:therapeutic use; D004311:Double-Blind Method; D017079:Exercise Tolerance / Q000187:drug effects / Q000502:physiology; D005260:Female; D005500:Follow-Up Studies; D006330:Heart Defects, Congenital / Q000150:complications; D006352:Heart Ventricles / Q000187:drug effects* / Q000503:physiopathology*; D006801:Humans; D008279:Magnetic Resonance Imaging; D008297:Male; D061330:Multidetector Computed Tomography; D017063:Outcome Assessment, Health Care; D010865:Pilot Projects; D011788:Quality of Life; D013318:Stroke Volume / Q000187:drug effects* / Q000502:physiology*; D013777:Tetrazoles / Q000009:adverse effects / Q000494:pharmacology* / Q000627:therapeutic use; D014188:Transposition of Great Vessels / Q000150:complications; D014633:Valine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000494:pharmacology / Q000627:therapeutic use; D000068756:Valsartan; D018497:Ventricular Dysfunction, Right / Q000188:drug therapy / Q000209:etiology / Q000503:physiopathology
chemical_list: D047228:Angiotensin II Type 1 Receptor Blockers; D013777:Tetrazoles; D000068756:Valsartan; D014633:Valine