Congenital Heart DiseaseNCT06196801
Efficacy of Triple-Combination Therapy in Severe PAH-CHD
An observational study of Congenital Heart Disease and Pulmonary Arterial Hypertension, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial 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 hemodynamic impact. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Congenital Heart Disease, Pulmonary Arterial Hypertension
- What is being tested?
- Triple-combination therapy
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 17 Jun 2022to 1 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patints diagnosed of congenital heart diseases with severe pulmonary arterial hypertension
Who may be able to join
- 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
Who cannot join
- 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.
Show all 12Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
China1 site
Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University
Guangzhou, Guangdong, 510080
About this study
Official title: Efficacy of Triple-Combination Therapy in Severe Pulmonary Arterial Hypertension Associated Congenital Heart Diseases
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.
- Being tested
- Triple-combination therapy
- Medical subject headings
- Heart Defects, Congenital, Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triple-combination therapyDrug
phosphodiesterase 5 inhibitors, endothelin receptor antagonist, and parenteral prostacyclin
| Study group | Role | What they receive |
|---|---|---|
| Triple Combination therapy | Not described Receives: Drug: Triple-combination therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary hemodynamics
comparison of hemodynamics at baseline, before and after surgery/intervention, assessed by RHC
Measured: 6 months,12 months
Secondary outcomes (5)
Pulmonary hemodynamics
Measured: perioperative period
Vasodilators average usage and compliance
Measured: 6 months, 12 months
Surgery success rate and adverse event
Measured: surgery perioperative period
Other monitoring data
Measured: surgery perioperative period
Other examination results
Measured: surgery perioperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2024
- Study start17 Jun 2022
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Caojin, MD, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06196801
- Sponsor's protocol ID
- Triple CHD PAH 2021
- Status last verified
- Mar 2025
- First submitted
- 26 Dec 2023
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Triple-Combination Therapy in Severe Pulmonary Arterial Hypertension Associated Congenital Heart Diseases
- ClinicalTrials.gov ID
- NCT06196801
- Acronym / sponsor ID
- Triple CHD PAH 2021
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- 17 Jun 2022 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 9 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Triple Combination therapy | – | Drug: Triple-combination therapy |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patints diagnosed of congenital heart diseases with severe pulmonary arterial hypertension
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Triple-combination therapyphosphodiesterase 5 inhibitors, endothelin receptor antagonist, and parenteral prostacyclin | Drug | Triple Combination therapy |
Primary outcome
Pulmonary hemodynamics
Time frame: 6 months,12 months
comparison of hemodynamics at baseline, before and after surgery/intervention, assessed by RHC
5 secondary outcomes
Pulmonary hemodynamics
Time frame: perioperative period
Vasodilators average usage and compliance
Time frame: 6 months, 12 months
Surgery success rate and adverse event
Time frame: surgery perioperative period
Other monitoring data
Time frame: surgery perioperative period
Other examination results
Time frame: surgery perioperative period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease and Pulmonary Arterial Hypertension, run by Guangdong Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary hemodynamics (time frame: 6 months,12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.