Riociguat in pulmonary hypertension and heart failure with preserved ejection fraction: The haemoDYNAMIC trial

Theresa Marie Dachs, Franz Duca, Rene Rettl, Christina Binder-Rodriguez, Daniel Dalos, Luciana Camuz Ligios, Andreas Kammerlander, Ekkehard Grünig, Ingrid Pretsch, Regina Steringer-Mascherbauer, Klemens Ablasser, Manfred Wargenau, Julia Mascherbauer, Irene M. Lang, Christian Hengstenberg, Roza Badr-Eslam, Johannes Kastner, Diana Bonderman*

*Corresponding author for this work

Research output: Journal article (peer-reviewed)Journal article

38 Citations (Scopus)

Abstract

Aims: The presence of pulmonary hypertension (PH) severely aggravates the clinical course of heart failure with preserved ejection fraction (HFpEF). To date, neither established heart failure therapies nor pulmonary vasodilators proved beneficial. This study investigated the efficacy of chronic treatment with the oral soluble guanylate cyclase stimulator riociguat in patients with PH-HFpEF. Methods and Results: The phase IIb, randomized, double-blind, placebo-controlled, parallel-group, multicentre DYNAMIC trial assessed riociguat in PH-HFpEF. Patients were recruited at five hospitals across Austria and Germany. Key eligibility criteria were mean pulmonary artery pressure ≥25mmHg, pulmonary arterial wedge pressure >15mmHg, and left ventricular ejection fraction ≥50%. Patients were randomized to oral treatment with riociguat or placebo (1:1). Patients started at 0.5mg three times daily (TID) and were up-Titrated to 1.5mg TID. The primary efficacy endpoint was change from baseline to week 26 in cardiac output (CO) at rest, measured by right heart catheterization. Primary efficacy analyses were performed on the full analysis set. Fifty-eight patients received riociguat and 56 patients placebo. After 26 weeks, CO increased by 0.37 ± 1.263L/min in the riociguat group and decreased by-0.11 ± 0.921L/min in the placebo group (least-squares mean difference: 0.54L/min, 95% confidence interval 0.112, 0.971; P = 0.0142). Five patients dropped out due to riociguat-related adverse events but no riociguat-related serious adverse event or death occurred. Conclusion: The vasodilator riociguat improved haemodynamics in PH-HFpEF. Riociguat was safe in most patients but led to more dropouts as compared to placebo and did not change clinical symptoms within the study period.

Original languageEnglish
Pages (from-to)3402-3413
Number of pages12
JournalEuropean Heart Journal
Volume43
Issue number36
DOIs
Publication statusPublished - 21 Sept 2022

Keywords

  • Heart failure with preserved ejection fraction
  • Pulmonary hypertension
  • Randomized controlled trial
  • Riociguat
  • Soluble guanylate cyclase stimulation

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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