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01.12.2016 | original article | Ausgabe 23-24/2016 Open Access

Wiener klinische Wochenschrift 23-24/2016

Evaluation of the pharmacoDYNAMIC effects of riociguat in subjects with pulmonary hypertension and heart failure with preserved ejection fraction

Study protocol for a randomized controlled trial

Zeitschrift:
Wiener klinische Wochenschrift > Ausgabe 23-24/2016
Autoren:
MD Julia Mascherbauer, MD Ekkehard Grünig, MD Michael Halank, MD Wolfgang Hohenforst-Schmidt, MD Andreas A. Kammerlander, MD Ingrid Pretsch, MD Regina Steringer-Mascherbauer, MD Silvia Ulrich, MD Irene M. Lang, PhD Manfred Wargenau, MD Reiner Frey, MD Diana Bonderman
Wichtige Hinweise
Author contributions JM and DB were responsible for conception and design of the research and drafting as well as supervision. EG, MH, WH, AAK, IP, RS, SU, IML and MW critically revised the manuscript for important intellectual content. RF was involved in the conception and design of the protocol. All authors have read and approved the final manuscript.

Summary

Background

The presence of pulmonary hypertension (PH) severely aggravates the clinical course of heart failure with preserved ejection fraction (HFPEF) resulting in substantial morbidity and mortality. So far, neither established heart failure therapies nor pulmonary vasodilators have proven to be effective for this condition. Riociguat (Adempas®, BAY 63-2521), a stimulator of soluble guanylate cyclase, is a novel pulmonary and systemic vasodilator that has been approved for the treatment of precapillary forms of PH. With regard to postcapillary PH, the DILATE-1 study was a multicenter, double-blind, randomized, placebo-controlled single-dose study in subjects with PH associated with HFPEF. Although there was no significant change in the primary outcome measure, peak decrease in mean pulmonary artery pressure with riociguat versus placebo, riociguat significantly increased stroke volume without changing heart rate, pulmonary artery wedge pressure, transpulmonary pressure gradient or pulmonary vascular resistance. The present study is designed to test the efficacy of long-term treatment with riociguat in patients with PH associated with HFPEF.

Methods/study design

The DYNAMIC study is a randomized, double-blind, placebo-controlled, parallel-group, multicenter clinical phase IIb trial evaluating the efficacy, safety and kinetics of riociguat in PH-HFPEF patients. The drug will be given over 26 weeks to evaluate the effects of riociguat versus placebo. The primary efficacy variable will be the change from baseline in cardiac output at rest, measured by right heart catheter after 26 weeks of study drug treatment. Additional efficacy variables will be changes from baseline in further hemodynamic parameters, changes in left and right atrial area, right ventricular volume, as well as right ventricular ejection fraction measured by cardiac magnetic resonance imaging, and changes from baseline in World Health Organization (WHO) class and N‑terminal prohormone B‑type natriuretic peptide (NT-proBNP).
The trial was registered on 25 August 2014 (EudraCT Number: 2014-003055-60; www.​clinicaltrialsre​gister.​eu).
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