Status:
ACTIVE_NOT_RECRUITING
Efficacy of Triple-Combination Therapy in Severe PAH-CHD
Lead Sponsor:
Guangdong Provincial People's Hospital
Conditions:
Congenital Heart Disease
Pulmonary Arterial Hypertension
Eligibility:
All Genders
14+ years
Brief Summary
Congenital heart disease (CHD) is a leading cause of pulmonary arterial hypertension (PAH) worldwide. Treatment for PAH associated with CHD (PAH-CHD) depends on the defect's type, size, and hemodynami...
Eligibility Criteria
Inclusion
- Subject is diagnosed with congenital heart diseases (CHD) and associated pulmonary arterial hypertension (PAH)
- Subject is under borderline hemodynamics status and ineligible for congenital heart diseases closure, confirmed by RHC: Qp/Qs：\< 1.5, Rp/Rs \> 0.3 and PVR \> 5 Wood units
- Subject signs an informed Consent Form and is willing to participate in follow-up visits
Exclusion
- Subject is diagnosed with other etiology of pulmonary arterial hypertension, e.g. left heart diseases associated pulmonary arterial hypertension.
- Subject is diagnosed with other types of PAH-CHD, e.g. Eisenmenger syndrome, PAH with small/coincidentalb defects
- Subject had cerebral hemorrhage, bleeding events in other organs within 3 months or was in high risk of bleeding.
- Subject is diagnosed of hepatic insufficiency: ALT or AST\>3×ULN at the screening visit.
- Subject is diagnosed of moderate to severe renal insufficiency: eGFR\<30ml/min/1.73m2 at the screening visit.
- Subject has uncontrolled arrhythmia with clinical significance within 90 days.
- Subject is diagnosed of the following diseases or received following medical interventions with 90 days: unstable angina, severe coronary atherosclerosis or myocardial infarction, cerebrovascular disease, deep vein thrombosis, pulmonary embolism, percutaneous coronary intervention, coronary artery bypass grafting, carotid artery intervention, peripheral artery intervention.
- Subject is diagnosed of malignant tumor (exception: tumors that have been cured and have not recurred in the last 5 years, basal cell and squamous cell skin cancers that have been completely resected, and cancers of any type in situ that have been completely resected)
- Subject cannot follow the study procedure due to other acute or chronic diseases.
- Subject is under other RCT.
- Subject has a life expectancy \<1 year.
- Subject cannot follow the study procedure due to other reasons in the opinion of the investigators. (alcoholic, drug abuse, lack of compliance)
Key Trial Info
Start Date :
June 17 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06196801
Start Date
June 17 2022
End Date
December 1 2025
Last Update
March 12 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University
Guangzhou, Guangdong, China, 510080