A Study to Test the Effects of Riociguat in Patients With Pulmonary Hypertension Associated With Left Ventricular Systolic Dysfunction

Summary

The aim of this study is to assess whether increasing oral doses of Riociguat are safe and improve the well-being, symptoms and outcome in patients with pulmonary hypertension associated with left ventricular systolic dysfunction

Timeline

Start

2010-04-14

Primary completion

2012-06-06

Completion

2025-07-23

Outcome

Missed primary endpoint

paper Although the primary end point of the study was not met PMID 23775260 ↗

registry Riociguat (Adempas, BAY63-2521) up to 2 mg vs Placebo; p = 0.1044 NCT01065454 ↗

Publications

• Results Ghio S, Bonderman D, Felix SB, Ghofrani HA, Michelakis ED, Mitrovic V, Oudiz RJ, Frey R, Roessig L, Semigran MJ. Left ventricular systolic dysfunction associated with pulmonary hypertension riociguat trial (LEPHT): rationale and design. Eur J Heart Fail. 2012 Aug;14(8):946-53. doi: 10.1093/eurjhf/hfs071. Epub 2012 Jun 20.
• Results Bonderman D, Ghio S, Felix SB, Ghofrani HA, Michelakis E, Mitrovic V, Oudiz RJ, Boateng F, Scalise AV, Roessig L, Semigran MJ; Left Ventricular Systolic Dysfunction Associated With Pulmonary Hypertension Riociguat Trial (LEPHT) Study Group. Riociguat for patients with pulmonary hypertension caused by systolic left ventricular dysfunction: a phase IIb double-blind, randomized, placebo-controlled, dose-ranging hemodynamic study. Circulation. 2013 Jul 30;128(5):502-11. doi: 10.1161/CIRCULATIONAHA.113.001458. Epub 2013 Jun 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Riociguat	Other / unclassified	0.5 mg	Oral
Subject	Riociguat	Other / unclassified	1 mg	Oral
Subject	Riociguat	Other / unclassified	2 mg	Oral

Indications