A coalition of hospitals in Spain is launching a new study to assess the mortality risk profile and characteristics of patients with pulmonary arterial hypertension (PAH) who underwent treatment with selexipag between 2017 and 2021.
Selexipag is an IP prostacyclin receptor agonist that will not be administered during the study period.
The study is currently recruiting adult patients (over 18 years of age) with PAH who have been treated with prostacyclin receptor agonists as they are at an intermediate risk of death at 1 year. Patients with active malignant tumors are not eligible to participate.
PAH is a rare, progressive disease characterized by narrowing and thickening of the pulmonary arteries. This thickening leads to reduced blood flow and increased pulmonary and cardiac blood pressure, which over time can lead to right ventricular heart failure.
Read more about PAH therapies
Treatment for PAH can include vasodilators such as prostacyclin receptor agonists, which help the pulmonary vessels relax and improve blood flow. Selexipag was approved by the US Food and Drug Administration in 2018 to reduce exercise-associated symptoms in patients with PAH, to delay disease progression, and to reduce their risk of hospitalization.
The primary outcome measure of this new study is clinical improvement as defined by the percentage of patients with a reduced annual mortality risk profile. Secondary outcome measures are the percentage of clinical tests used, including the study treatment, and the incidence of disease progression events such as hospitalization for pulmonary hypertension or for any cause, the need for systemic prostacyclins, deaths due to PAH, and all-cause mortality.
The study was initiated on June 1, 2021, and the primary completion date is estimated to be December 2023. The estimated study completion date is December 31, 2024.
RWD patients with pulmonary arterial hypertension treated with IP prostacyclin receptor agonists (RAMPHA). ClinicalTrials.gov. October 31, 2022. Updated November 7, 2022. Accessed November 9, 2022.