Tadalafil for Severe Pulmonary Hypertension Due to Chronic Obstructive Pulmonary Disease (NCT05844462) | Clinical Trial Compass
RecruitingPhase 3
Tadalafil for Severe Pulmonary Hypertension Due to Chronic Obstructive Pulmonary Disease
France200 participantsStarted 2024-02-01
Plain-language 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.
Who can participate
Age range18 Years – 85 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients ≥ 18 and \<85 years at inclusion,
* Dyspnea WHO functional class II to IV,
* Severe precapillary pulmonary hypertension defined by :
* a mean pulmonary artery pressure (mPAP) \>20
* associated with normal pulmonary artery wedge pressure (PawP ≤15 mmHg)
* and pulmonary vascular resistance (PVR) \>5 WU
* COPD diagnosed according to current international recommendation with persistent airflow limitation defined by post-bronchodilatator Forced expiratory volume in 1 second (FEV1) / forced vital capacity (FVC): FEV1/FVC \< 0.70,
* Naive patients from PDE5i (sildenafil, tadalafil) PH treatments and who did not receive other specific PH treatment in the last 3 months (bosentan, ambrisentan, macitentan, riociguat, epoprostenol, treprostinil, iloprost),
* Treatments for COPD need to be stable for at least 1 month before screening visit,
* Patients who fulfill criteria for a supplemental long-term oxygen therapy need to be supplied sufficiently before study entry. The amount of supplemental oxygen and the delivery method need to be stable for at least 1 month before screening visit,
* Patients who are able to understand and follow instructions and who are able to participate in the study for the entire period,
* Patients must have given their written informed consent to participate in the study after having received adequate previous information and prior to any study-specific procedures,
* Affiliation to a social security regime,
Exclusion Crite…