Riociguat for Pulmonary Hypertension Due to Heart Failure

(LEPHT Trial)

Recruiting at 91 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

202 Participants Needed

What You Need to Know Before You Apply

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

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.

How does the drug Riociguat differ from other treatments for pulmonary hypertension due to heart failure?

Riociguat is unique because it works by stimulating an enzyme called soluble guanylate cyclase, which helps relax blood vessels and improve blood flow, unlike other treatments that may focus on different pathways. This mechanism can be particularly beneficial for patients with pulmonary hypertension due to heart failure, offering a novel approach compared to standard therapies. ^{1 2 3 4 5}

What data supports the effectiveness of the drug Riociguat for treating pulmonary hypertension due to heart failure?

Riociguat has been shown to be effective in treating pulmonary arterial hypertension (a type of high blood pressure affecting the lungs) and chronic thromboembolic pulmonary hypertension (a condition where blood clots block the blood vessels in the lungs), improving exercise capacity and lung function. Although it is not specifically approved for heart failure-related pulmonary hypertension, its success in similar conditions suggests potential benefits. ^{6 7 8 9 10}

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. United States pubmed.ncbi.nlm.nih.gov

Riociguat (adempas): a novel agent for the treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

An Unlikely Trio: Profound Anemia, Elevated Lactate, and Riociguat. [2022]

3. Spain pubmed.ncbi.nlm.nih.gov

Riociguat for the management of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension. [2017]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Riociguat: a review of its use in patients with chronic thromboembolic pulmonary hypertension or pulmonary arterial hypertension. [2018]

5. France pubmed.ncbi.nlm.nih.gov

Riociguat real-world use in patients with chronic thromboembolic pulmonary hypertension: A retrospective, observational cohort study in France. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Cardiovascular events associated with rofecoxib: final analysis of the APPROVe trial. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Rofecoxib and cardiovascular adverse events in adjuvant treatment of colorectal cancer. [2014]

8. United States pubmed.ncbi.nlm.nih.gov

Thromboembolic cardiovascular risk among arthritis patients using cyclooxygenase-2-selective inhibitor or nonselective cyclooxygenase inhibitor nonsteroidal anti-inflammatory drugs. [2015]

9. Poland pubmed.ncbi.nlm.nih.gov

Effect of nimesulide-a preferential COX-2 inhibitor on arterial blood pressure, compared to ketoprofen. [2015]

10. England pubmed.ncbi.nlm.nih.gov

Non-steroidal anti-inflammatory drug (NSAID) related inhibition of aldosterone glucuronidation and arterial dysfunction in patients with rheumatoid arthritis: a cross-sectional clinical study. [2021]