Phase 3 Pulmonary Hypertension Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 18 to 84 years old at the time of joining the trial
• People experiencing shortness of breath classified as moderate to very severe (WHO functional class II to IV)
• People who have been diagnosed with severe pulmonary hypertension (high blood pressure in the lungs) confirmed by specific pressure and resistance measurements taken during a heart catheter procedure
• People who have been diagnosed with COPD (chronic obstructive pulmonary disease) confirmed by a breathing test showing a specific pattern of airflow limitation
• People who have not previously been treated with certain pulmonary hypertension medications called PDE5 inhibitors (such as sildenafil or tadalafil), and have not received other specific pulmonary hypertension treatments in the last 3 months
• People whose COPD treatments have been stable for at least 1 month before the screening visit
• People who require long-term supplemental oxygen and whose oxygen supply type and amount have been stable for at least 1 month before the screening visit
• People who are able to understand instructions and participate in the study for its full duration
• People who have given written consent to participate after being fully informed about the study
• People who are affiliated with a social security scheme (confirm with trial site — this appears to relate to French social security)

Who may not be able to join:

• People with a medical condition that, in the opinion of the investigating doctor, would prevent them from completing the study
• People with a serious underlying illness, such as active cancer, where life expectancy is expected to be less than 12 months
• People whose pulmonary hypertension is caused by conditions other than chronic respiratory disease (for example, certain heart or blood clot-related causes of lung high blood pressure)
• People with other significant lung conditions such as interstitial lung disease, sarcoidosis, or untreated severe sleep apnea
• People who are unable to walk at least 50 metres during a standard 6-minute walk test, or who are unable to perform this test at all
• People who have been hospitalised for a COPD flare-up in the 8 weeks before the screening visit
• People whose COPD airflow limitation is either very mild (above 80% of the predicted normal value) or very severe (below 30% of the predicted normal value)
• People who are already on a waiting list for a lung transplant at the time of joining
• People whose heart's left pumping chamber is significantly weakened, as shown on an echocardiogram (heart ultrasound)
• People receiving state medical aid (AME) (confirm with trial site — this appears to relate to a specific French social assistance programme)
• People who have participated in another clinical trial in the 3 months before this study, or who are participating in another trial at the same time
• Women who are pregnant, breastfeeding, or who could become pregnant and are not using a specific combination of contraception methods as outlined by the trial (confirm with trial site for full details)
• People under legal guardianship or a curatorship arrangement

People may also not be able to join due to the specific trial medication (tadalafil), including those who have:

• Severe kidney failure
• Severe liver disease (Child-Pugh class C cirrhosis)
• Very low blood pressure (below 90/50 mmHg)
• Had a heart attack within the last 90 days
• A history of a specific type of vision nerve damage (anterior ischemic optic neuropathy)
• A known allergy or sensitivity to tadalafil or its ingredients
• Currently taking certain other medications that interact with tadalafil, including specific antifungal or antibiotic drugs, riociguat, other PDE5 inhibitor medicines, nitrate medications, or doxazosin
• Certain serious heart conditions, including significant heart valve disease, constrictive pericarditis, certain types of heart muscle disease, dangerous heart rhythm problems, symptomatic coronary artery disease, or uncontrolled high blood pressure
• Certain penile conditions including angulation, cavernosal fibrosis, Peyronie's disease, or a history of prolonged painful erection (priapism)
• A lung or upper airway infection requiring antibiotics, or a blood clot in the lung, in the 4 weeks before screening
• Participated in a pulmonary rehabilitation programme in the 4 weeks before screening, or have one planned during the study
• Required urgent medication to support heart function due to right heart failure in the 4 weeks before screening

Important: Always verify eligibility with the trial site directly before applying.