Comparison of Initial Dual Oral Combination Therapy to Monotherapy in Pulmonary Arterial Hypertension Patients With Cardiovascular Comorbidities

What this Trial Is About

Pulmonary arterial hypertension (PAH) is a rare and progressive condition that affects the blood vessels in the lungs and often leads to right heart failure and early death. This trial focuses on newly diagnosed PAH patients who have at least two cardiovascular health issues such as high blood pressure, diabetes, obesity, coronary artery disease, or atrial fibrillation. Researchers aim to compare two treatment approaches to better understand which may be more effective and safer for patients with these additional health concerns. Participants will be randomly assigned to one of two treatment groups. One group will receive a combination of two oral drugs: tadalafil and ambrisentan, while the other group will receive tadalafil with a placebo that looks like ambrisentan. Tadalafil starts at 20 mg daily for a week and may increase to 40 mg daily; ambrisentan starts at 5 mg daily for four weeks and may increase to 10 mg daily, with adjustments allowed if needed. The study will last about 37 months and is designed as a phase IV, open-label trial conducted in multiple centers. During the trial, participants will be followed for at least 24 weeks, with researchers monitoring their risk status using a noninvasive method based on European guidelines. Other assessments include lung blood vessel resistance, heart function measures, walking distance, quality of life surveys, and tracking any clinical worsening or death. Safety and treatment effects will be closely observed throughout the study to provide important information on how these therapies work in patients with PAH and cardiovascular comorbidities.

COMMODITIES Trial: Initial Dual Oral Therapy vs Monotherapy in PAH With Cardiovascular Comorbidities