RecruitingNot ApplicableNCT04972656

Treatment With Ambrisentan in Patients With Borderline Pulmonary Arterial Hypertension

Treatment With Ambrisentan in Patients With Borderline Pulmonary Arterial Hypertension: a Multicenter, Randomized, Double-blind, Placebo-controlled Study


Sponsor

Nanjing First Hospital, Nanjing Medical University

Enrollment

420 participants

Start Date

Sep 5, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

An Investigator initiated trial (IIT) using a prospective, randomized, double-blind, parallel group, placebo-controlled, clinical study design.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether ambrisentan — a drug normally used for pulmonary arterial hypertension — can benefit people with borderline elevated pressure in the blood vessels of the lungs, before the condition progresses to full pulmonary arterial hypertension. **You may be eligible if...** - You are 18 years or older - Your mean pulmonary artery pressure (measured by right heart catheterisation) is between 21 and 24 mmHg, with normal wedge pressure (below 15 mmHg) - Your condition belongs to Group 1 pulmonary hypertension, which includes idiopathic, hereditary, connective tissue disease-related, HIV-related, portal hypertension-related, or congenital heart disease-related causes - You are willing to consent and comply with study procedures **You may NOT be eligible if...** - Your mean pulmonary artery pressure is above 25 mmHg (established pulmonary arterial hypertension) - Your elevated lung pressure is caused by heart failure or lung disease (Groups 2 or 3) - You have contraindications to ambrisentan Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGAmbrisentan

Titration: Monotherapy using ambrisentan will be initialized at a beginning dose of 5 mg (once daily). Drug intake is scheduled at the morning. After 4 weeks monitoring, the dose of ambrisentan will be uptitrated to 10 mg once daily. Otherwise, if intolerability is indicated, a dose of 5 mg (once daily) will be maintained through the study duration. Maximum dose allowed: not to exceed 10 mg/day. Administration: Ambrisentan will be administered orally with or without food intake.

DRUGPlacebo

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.


Locations(1)

Nanjing First Hospital

Nanjing, Jiangsu, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04972656


Related Trials