Riociguat for patients with pulmonary hypertension caused by systolic left ventricular dysfunction: A phase IIb double-blind, randomized, placebo-controlled, dose-ranging hemodynamic study

Diana Bonderman, Stefano Ghio, Stephan B. Felix, Hossein Ardeschir Ghofrani, Evangelos Michelakis, Veselin Mitrovic, Ronald J. Oudiz, Francis Boateng, Andrea Viviana Scalise, Lothar Roessig, Marc J. Semigran

Research output: Contribution to journalArticlepeer-review

Abstract

BACKGROUND - : Pulmonary hypertension caused by systolic left ventricular dysfunction is associated with significant morbidity and mortality; however, no treatment is approved for this indication. We hypothesized that riociguat, a novel soluble guanylate cyclase stimulator, would have beneficial hemodynamic effects in patients with pulmonary hypertension caused by systolic left ventricular dysfunction. METHODS AND RESULTS - : Overall, 201 patients with heart failure resulting from pulmonary hypertension caused by systolic left ventricular dysfunction were randomized to double-blind treatment with oral placebo or riociguat (0.5, 1, or 2 mg 3 times daily) for 16 weeks in 4 parallel arms. The primary outcome was the placebo-corrected change from baseline at week 16 in mean pulmonary artery pressure. Although the decrease in mean pulmonary artery pressure in the riociguat 2 mg group (-6.1±1.3 mm Hg; P

Original languageEnglish
Pages (from-to)502-511
Number of pages10
JournalCirculation
Volume128
Issue number5
DOIs
Publication statusPublished - Jul 30 2013

Keywords

  • clinical trial
  • heart failure, systolic
  • hypertension, pulmonary
  • riociguat
  • soluble guanylate cyclase

ASJC Scopus subject areas

  • Physiology (medical)
  • Cardiology and Cardiovascular Medicine

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