Riociguat for Pulmonary Hypertension Due to Heart Failure
(LEPHT Trial)

Recruiting in Palo Alto (17 mi)

+91 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Bayer

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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

Research Team

Bayer Study Director

Principal Investigator

Bayer

Eligibility Criteria

This trial is for men and women who have pulmonary hypertension due to weak heart pumping (left ventricular systolic dysfunction) despite being on the best treatment for heart failure. It's not open to those with other types of high blood pressure in the lungs besides group 2.1 as classified at Dana Point.

Inclusion Criteria

I have high blood pressure in my lungs due to heart issues, despite treatment.

Exclusion Criteria

My pulmonary hypertension is not classified as group 2.1.

Treatment Details

Interventions

Placebo (Drug)
Riociguat (Adempas, BAY63-2521) (Soluble Guanylate Cyclase Stimulator)

Trial OverviewThe study is testing Riociguat, a medication that might improve symptoms and overall health in patients with certain kinds of lung-related high blood pressure linked to heart issues. Participants will either receive Riociguat or a placebo without knowing which one they're getting.

Participant Groups

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Riociguat (Adempas, BAY63-2521) up to 2 mgExperimental Treatment1 Intervention

Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).

Group II: Riociguat (Adempas, BAY63-2521) up to 1 mgExperimental Treatment1 Intervention

Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).

Group III: Riociguat (Adempas, BAY63-2521) fixed 0.5 mgExperimental Treatment1 Intervention

Participants received riociguat 0.5 mg tid (fixed dose).

Group IV: PlaceboPlacebo Group1 Intervention

Participants received placebo tid.