Comparing Sequential and Initial Combination Therapy Using Ambrisentan and Tadalafil for Pulmonary Arterial Hypertension Patients

What this Trial Is About

Researchers are conducting a multicenter, randomized, controlled, double-blind trial to compare the effects of sequential versus initial combination therapy in patients with pulmonary arterial hypertension PAH. The study focuses on symptomatic patients classified as low or moderate risk by 2022 guidelines, who have not received chronic PAH treatments recently. The primary goal is to determine if the sequential combination therapy is not less effective than starting with combination therapy, measured by changes in walking distance after 12 months. Participants will receive treatments involving Ambrisentan and Tadalafil. One group receives both drugs immediately after randomization, while two other groups start with one drug and add the other sequentially if low-risk status is not achieved at 4, 8, or 12 months. Risk assessments occur every four months, and treatment may be escalated based on clinical failure or risk status, including options to add other therapies or switch medications. During the study, participants will undergo regular risk evaluations, walking distance tests, blood tests, and assessments of heart and lung function at baseline and multiple time points up to 12 months. Researchers will monitor safety continuously with an independent board. The study duration is about four years, focusing on exercise capacity changes and clinical event timing as key outcomes.

Comparison of Sequential to Initial Combination Therapy in PAH