Riociguat for Pulmonary Hypertension Due to Heart Failure

(LEPHT Trial)

No longer recruiting at 104 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Bayer

Disqualifiers: Other pulmonary hypertension types

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a medication called Riociguat (Adempas, BAY63-2521) to determine its effectiveness for people with pulmonary hypertension linked to heart failure. Researchers aim to assess whether different doses of Riociguat are safe and can improve symptoms and overall well-being. Participants will receive either a placebo or varying doses of Riociguat. This trial may suit individuals with ongoing pulmonary hypertension symptoms despite current heart failure treatment. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that participants should have optimized heart failure therapy, which suggests you may need to continue your current treatment.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that Riociguat is generally safe for most patients. Research on lung-related high blood pressure caused by heart problems found that Riociguat was well tolerated and improved heart function. However, some patients discontinued the treatment more frequently than those on a placebo, a harmless pill used for comparison. This suggests that while many tolerate the treatment well, some might experience side effects that lead to discontinuation. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment for pulmonary hypertension?

Unlike the standard treatments for pulmonary hypertension due to heart failure, which often include medications like diuretics, beta-blockers, and ACE inhibitors, Riociguat (Adempas) offers a unique mechanism of action. Riociguat works by stimulating the soluble guanylate cyclase (sGC) enzyme, which plays a crucial role in the nitric oxide signaling pathway. This can help relax blood vessels and reduce blood pressure in the lungs more effectively. Researchers are excited about Riociguat because it targets the underlying pathways of pulmonary hypertension directly, potentially offering better outcomes for patients who don't respond well to current therapies.

What evidence suggests that Riociguat might be an effective treatment for pulmonary hypertension?

Research has shown that Riociguat may benefit people with pulmonary hypertension, which is high blood pressure in the lungs caused by heart failure. This trial will evaluate different dosages of Riociguat, including fixed and increasing doses, to determine its effectiveness. Studies have found that Riociguat can improve blood flow by widening blood vessels, which might help the heart pump more effectively. In patients with certain types of pulmonary hypertension, Riociguat improved symptoms and overall heart function. Some studies found it was generally safe, although some groups had more participants who stopped taking it. These findings suggest potential benefits for heart failure patients with pulmonary hypertension. ^{1 2 6 7 8}

Who Is on the Research Team?

Bayer Study Director

Principal Investigator

Bayer

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Riociguat or placebo for 16 weeks to assess safety and hemodynamic effects

16 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Riociguat (Adempas, BAY63-2521)

Trial Overview The 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.

How Is the Trial Designed?

Group I: Riociguat (Adempas, BAY63-2521) up to 2 mg Experimental Treatment 1 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 mg Experimental Treatment 1 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 mg Experimental Treatment 1 Intervention

Participants received riociguat 0.5 mg tid (fixed dose).

Group IV: Placebo Placebo Group 1 Intervention

Participants received placebo tid.

Who Is Running the Clinical Trial?

Bayer

Lead Sponsor

Trials

2,291

Recruited

25,560,000+

Founded

1863

Headquarters

Leverkusen, Germany

Known For

Pharmaceutical Innovations

Top Products

Aspirin, Aleve, Yaz, Nexavar

Bill Anderson

Bayer

Chief Executive Officer since 2023

BSc in Chemical Engineering from the University of Texas, MSc in Chemical Engineering and Management from MIT

Michael Devoy

Bayer

Chief Medical Officer since 2014

MD, PhD

Published Research Related to This Trial

Riociguat (Adempas) is an innovative medication specifically designed to treat pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH), conditions that cause high blood pressure in the lungs.

Clinical studies have demonstrated that riociguat effectively improves exercise capacity and overall functional status in patients with these types of pulmonary hypertension, making it a valuable treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Riociguat (adempas): a novel agent for the treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension. Khaybullina, D., Patel, A., Zerilli, T.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9492239/

Riociguat in pulmonary hypertension and heart failure with ... This study investigated the efficacy of chronic treatment with the oral soluble guanylate cyclase stimulator riociguat in patients with PH-HFpEF ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT00810693

A Study to Evaluate Efficacy and Safety of Oral BAY63- ... Riociguat for pulmonary arterial hypertension associated with congenital heart disease. ... outcomes in patients with pulmonary arterial hypertension in ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35909264/

Riociguat in pulmonary hypertension and heart failure with ... The vasodilator riociguat improved haemodynamics in PH-HFpEF. Riociguat was safe in most patients but led to more dropouts as compared to ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT00855465

NCT00855465 | A Study to Evaluate Efficacy and Safety of ... The aim of the study is to assess the efficacy and safety of different doses of BAY63-2521, given orally for 16 weeks, in patients with Chronic Thromboembolic ...

5. withpower.com withpower.com/trial/phase-3-hypertension-pulmonary-3-2010-e4409

Riociguat for Pulmonary Hypertension Due to Heart Failure 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 ...

6. jhltonline.org jhltonline.org/article/S1053-2498(24)01807-2/fulltext

Safety and efficacy of riociguat in patients with pulmonary ... To investigate the impact of riociguat treatment in this patient population we analyzed pooled data from randomized controlled trials of riociguat.

7. ahajournals.org ahajournals.org/doi/10.1161/circulationaha.113.001458

Riociguat for Patients With Pulmonary Hypertension ... Riociguat was well tolerated in patients with pulmonary hypertension caused by systolic left ventricular dysfunction and improved cardiac index and pulmonary ...

8. acc.org acc.org/Latest-in-Cardiology/Clinical-Trials/2022/08/10/14/55/DYNAMIC

Riociguat in Pulmonary Hypertension and Heart Failure ... The results of this trial show that, among patients with HFpEF and PH, riociguat improved cardiac output at rest compared to placebo.