RecruitingPhase 3NCT05844462

Tadalafil for Severe Pulmonary Hypertension Due to Chronic Obstructive Pulmonary Disease

Efficacy of Phosphodiesterase Type 5 Inhibitors in Severe Pulmonary Hypertension Due to Chronic Obstructive Pulmonary Disease


Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

200 participants

Start Date

Feb 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

ERASE PH-COPD is a randomized double-blind study, with 2 parallel groups. Patients with severe pulmonary hypertension due to chronic obstructive pulmonary disease, will be randomly assigned to receive Tadalafil orally or placebo.


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether tadalafil — a drug used for pulmonary arterial hypertension and other conditions — can help people with severe pulmonary hypertension caused by chronic obstructive pulmonary disease (COPD). In COPD, damaged lungs can cause dangerously high blood pressure in the lung blood vessels, making breathing and physical activity very difficult. **You may be eligible if...** - You are 18 to 84 years old - You have COPD confirmed by breathing tests - You have been diagnosed with severe precapillary pulmonary hypertension through a heart catheterization test - Your shortness of breath is classified as WHO functional class II to IV - You have never previously taken a PDE5 inhibitor (such as sildenafil or tadalafil) for pulmonary hypertension **You may NOT be eligible if...** - You have a different cause of pulmonary hypertension (not COPD-related) - You have already been treated with pulmonary vasodilator medications - You have severe heart failure with low pumping function - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGTadalafil

Oral Tadalafil

DRUGPlacebo

Oral Placebo


Locations(1)

Kremlin Bicêtre

Le Kremlin-Bicêtre, France, France

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05844462


Related Trials