NCT06196801Active, not recruiting
Efficacy of Triple-Combination Therapy in Severe PAH-CHD
Efficacy of Triple-Combination Therapy in Severe Pulmonary Arterial Hypertension Associated Congenital Heart Diseases
Source: ClinicalTrials.gov · Last updated 12 Mar 2025
Brief summary (registry, in English)
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 hemodynamic impact. For those with CHD correction indications, early defect repair or interventional closure is crucial to prevent irreversible pulmonary vascular remodeling due to prolonged exposure to a left-to-right shunt. Current guidelines recommend triple-combination therapy, including phosphodiesterase 5 inhibitors, endothelin receptor antagonist, and parenteral prostacyclin, for patients with intermediate-high or high risk. Recent studies suggest that patients with PAH-CHD and borderline hemodynamics might regain eligibility for surgery after targeted vasodilatory treatment. Consequently, early initiation of triple-combination therapy may be critical for severe PAH-CHD patients to restore their surgical or interventional closure eligibility. Therefore, we conducted this prospective study to assess the effectiveness of triple-combination therapy in severe PAH-CHD cases.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 80 (estimated)
- First submitted
- 26 Dec 2023
- Start date
- 17 Jun 2022
- Primary completion date
- 1 Dec 2025
- Lead sponsor
- Guangdong Provincial People's Hospital
- NCT number
- NCT06196801
What you commit to
- Study type: Observational
- Planned participants: 80
- From 17 Jun 2022 to the primary completion date, 1 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 cannot follow the study procedure due to other reasons in the opinion of the investigators. (alcoholic, drug abuse, lack of compliance)
Other illness
- 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 has uncontrolled arrhythmia with clinical significance within 90 days.
- 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.
Lab values
- 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.
Other
- Subject is under other RCT.
- Subject has a life expectancy \<1 year.
Who the study is looking for
- 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
Age in the registry: 14 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.