Ambrisentan for Early Low-Risk Pulmonary Arterial Hypertension

NANot yet recruitingINTERVENTIONAL
Enrollment

410

Participants

Timeline

Start Date

May 15, 2025

Primary Completion Date

February 28, 2028

Study Completion Date

March 1, 2029

Conditions
Pulmonary Arterial Hypertension (PAH)
Interventions
DRUG

Ambrisentan

After two weeks of initial treatment, the study drugs' dose will be increased to two tablets per day (10 mg/day). If the patient cannot tolerate the increased dose (e.g., experiencing headache, dizziness, palpitations, hypotension, or other drug-related symptoms or signs), the dose will be reduced to 5 mg/day. If the study drug has reached the maximum allowable dose (two tablets/day) and the patient shows signs of worsening PAH or right heart failure, the clinician may decide to add diuretics (with the type and dosage left at the referring physician's discretion). The number and percentage of patients requiring diuretic combination therapy in both groups will be recorded. Other baseline treatment medications will remain unchanged through follow-up duration.

DRUG

Placebo

Placebo tablet (one to two tablets corresponding to one to two verum tablets). Administration: Placebo will be administrated orally with or without food intake in the morning.

All Listed Sponsors
lead

Nanjing First Hospital, Nanjing Medical University

OTHER