Status:
NOT_YET_RECRUITING
Ambrisentan for Early Low-Risk Pulmonary Arterial Hypertension
Lead Sponsor:
Nanjing First Hospital, Nanjing Medical University
Conditions:
Pulmonary Arterial Hypertension (PAH)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is an investigator-initiated, multicenter, randomized, double-blind, placebo-controlled clinical trial.
Detailed Description
Early-stage low-risk PAH is defined as mean pulmonary arterial pressure (mPAP) between 20 and 25 mmHg at rest, measured by right heart catheterization, and classified as low-risk based on the 2022 ESC...
Eligibility Criteria
Inclusion
- Age ≥ 18 years;
- mPAP \> 20 mmHg and \< 25 mmHg, pulmonary vascular resistance (PVR) \> 2 WUs and ≤ 3 WUs, and pulmonary arterial wedge pressure (PAWP) ≤ 15 mmHg via right heart catheterization (RHC); RHC measurement will be accepted if it was done within 7 days before enrollment;
- Group I PAH, including idiopathic PAH (IPAH), heritable PAH (HPAH), Drug- and toxin-induced PAH, associated with connective tissue disease (connective tissue disease at good control), associated with portal hypertension, associated with congenital heart disease;
- At low risk based on the 2022 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension three-strata risk-assessment model;
- The subject or a legally authorized representative must understand the study requirements, agree to the treatment procedures, and provide written informed consent before any study-specific procedures are performed;
- The subject must demonstrate a willingness and ability to comply with all protocol requirements.
Exclusion
- Patients currently receiving PAH specific medications, regardless of whether mPAP is between 20-25 mmHg. PAH specific medications include endothelin receptor antagonists (ERAs; e.g., bosentan, ambrisentan, macitentan), phosphodiesterase type 5 inhibitors (PDE5i; e.g., sildenafil, tadalafil, vardenafil), prostacyclin analogs (e.g., iloprost, epoprostenol, treprostinil, beraprost), soluble guanylate cyclase stimulators (e.g., riociguat). Intermittent use of PDE5 inhibitors for the treatment of male erectile dysfunction is permitted;
- Intolerance to ambrisentan or its excipients;
- Pulmonary veno-occlusive disease (PVOD);
- Pulmonary capillary hemangiomatosis (PCH);
- Within 6 months after congenital heart disease surgical repair or percutaneous closure procedure;
- Group II-V PH;
- Clinically significant anemia, defined as hemoglobin concentration below 75% of the lower limit of normal;
- Renal insufficiency, defined as estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m² within 3 months prior to enrollment;
- Elevated Alanine Aminotransferase （ALT） and/or Aspartate Aminotransferase （AST） exceeding 3 times the upper limit of normal (ULN);
- Systolic blood pressure \< 85 mmHg;
- Uncontrolled hypertension, defined as blood pressure \> 160/90 mmHg at rest and/or \> 220/120 mmHg under stress conditions;
- Participation in any clinical drug trial within 4 weeks prior to screening and/or planned participation in another clinical drug trial during this study;
- Expected life expectancy of less than 1 year;
- Pregnant or breastfeeding women.
Key Trial Info
Start Date :
May 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2029
Estimated Enrollment :
410 Patients enrolled
Trial Details
Trial ID
NCT06987097
Start Date
May 15 2025
End Date
March 1 2029
Last Update
May 23 2025
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