Congenital Heart Disease, Pulmonary HypertensionNCT07844213
Early Postoperative Triple Targeted Therapy in Patients With CHD-PAH in the "Grey Zone"
A study testing Treatment group (ambrisentan plus tadalafil plus treprostinil or macitentan plus tadalafil plus treprostinil) in people with Congenital Heart Disease, Pulmonary Hypertension, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial summary
The purpose of this study is to observe the efficacy of early application of triple targeted drug therapy, including trilostane, in patients with congenital heart disease who are in the "gray zone" of preoperative evaluation, have surgical repair indications after evaluation, and have undergone defect repair. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Congenital Heart Disease, Pulmonary Hypertension
- What is being tested?
- Treatment group (ambrisentan plus tadalafil plus treprostinil or macitentan plus tadalafil plus treprostinil)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 25 Aug 2022to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged 18 to 65
- Patients with congenital heart disease and pulmonary hypertension with clear diagnosis
- Pulmonary vascular resistance index (PVR) in hemodynamics of right heart catheterization before surgical repair: hemodynamics of right heartcatheterization before surgery conforms to "gray zone standard" (PVR: 4-8 Wood* m2, QP/QS > 1.5), acute vascular reaction test meets the positive standard (PVR: < 4 Wood* m2)
- Successfully performed surgical repair of congenital heart disease to close the defect
- Sign informed consent form
Who cannot join
- Other causes of PAH include pulmonary hypertension associated with left heart disease (valve disease)
- Other types of CHD-PAH, including Eisenmenger syndrome, PAH with small defects, etc.
- After evaluating the acute pulmonary vasodilation test by right heart catheterization, the result shows that the surgical prognosis is poor, and those who are not suitable for surgical treatment should not undergo surgical treatment.
- There are other surgical contraindications, including severe systemic diseases, severe mental disorders, severe cognitive dysfunction, and physical conditions that cannot tolerate surgery.
- Cannot provide informed consent
Trial locations and contacts
1 site in 1 country.
China1 site
Fuwai Hospital, National Center for Cardiovascular Diseases
Beijing, 100037
About this study
The purpose of this study is to observe the efficacy of early application of triple targeted drug therapy, including trilostane, in patients with congenital heart disease who are in the "gray zone" of preoperative evaluation, have surgical repair indications after evaluation, and have undergone defect repair.
Read the detailed description
This study is a prospective randomized controlled study. Including congenital heart disease combined with pulmonary hypertension, the hemodynamics in the right heart catheter before surgery conform to the "gray zone standard" (PVRi: 6-8 Wood * m2) in the 2018 Cologne Consensus.PVR/SVR 0.3-05), acute vascular reaction test met the positive standard (PVRi: < 6 Wood*m 2, PVR/SVR < 0.3), and CHD patients (including VSD, PDA, ASD) who underwent surgical repair, patients were randomly assigned to different treatment groups, The specific grouping is as follows: 1) 15 patients in the standard dual therapy group received dual therapy for 12 months, consisting of a phosphodiesterase type 5 inhibitor (tadalafil 20 mg qd or sildenafil 20~25 mg tid) combined with a phosphodiesterase 5 receptor antagonist (amlodipine 5 mg qd or macitentan 10 mg qd). 2) 15 patients in the early triple therapy group received the combination of a phosphodiesterase type 5 inhibitor (tadalafil 20 mg qd or sildenafil 20~25 mg tid), a phosphodiesterase-5 receptor antagonist (amlodipine 5 mg qd or maropitant 10 mg qd), and treprostinil. The dosage of pralatrexate needs to be titrated gradually, starting from 1.25 ng/min/kg, and titrated gradually to the patient's maximum tolerated dose (guideline dose of 15-20 ng/min/kg), and the duration of triple targeted drug therapy is at least 6 months. After 6 months, it can be adjusted to the standard dual therapy group to 12 months. Observation indexes The main observation indices are as follows:(1) Pulmonary vascular resistance measured by right heart catheterization one year after surgical repair and closure of defects. Secondary observation indicators: (1) Right atrial pressure, pulmonary artery pressure, PVR/SVR, cardiac index, mixed blood oxygen saturation, and systemic arterial blood oxygen saturation measured in right heart catheterization 12 months after surgery. (2) NT-proBNP level (3) 6-minute walk distance (4) WHO functional class (5) SF-36 self-assessment quality of life score (6) rehospitalization due to worsening heart failure, atrial septal defect shunt, lung transplant or heart-lung transplant, and other adverse events; (7) Drug-related adverse reaction events, including but not limited to hypotension, headache, muscle pain, injection site pain, injection site infection, bleeding, etc.
- Being tested
- Control group (ambrisentan plus tadalafil or macitentan plus tadalafil), Treatment group (ambrisentan plus tadalafil plus treprostinil or macitentan plus tadalafil plus treprostinil)
- Keywords
- Pulmonary hypertension, Congenital heart disease, Surgical repair, Targeted drug therapy, Prognosis
- Medical subject headings
- Heart Defects, Congenital, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control group (ambrisentan plus tadalafil or macitentan plus tadalafil)Drug
The control group received dual drug therapy: endothelin receptor antagonists (Ambrisentan 10mg qd, or Macitentan 10mg qd) combined with phosphodiesterase type 5 inhibitors (Tadalafil 20-40mg qd).
Treatment group (ambrisentan plus tadalafil plus treprostinil or macitentan plus tadalafil plus treprostinil)Drug
The treatment group received early triple therapy: endothelin receptor antagonist (Ambrisentan 10 mg qd or Macitentan 10 mg qd), a phosphodiesterase type 5 inhibitor ( Tadalafil 20-40 mg qd), and treprostinil. The Treprostinil dose was titrated gradually, starting at 1.25 ng/min/kg and escalated to the patient's maximum tolerated dose (target dose range: 15-20 ng/min/kg).
| Study group | Role | What they receive |
|---|---|---|
| Dual therapy group | Active comparator | Ambrisentan 10mg qd or Macitentan 10mg qd combined with Tadalafil 20-40mg qd Receives: Drug: Control group (ambrisentan plus tadalafil or macitentan plus tadalafil) |
| Early triple therapy group | Experimental | Ambrisentan 10mg qd or Macitentan 10mg qd combined with Tadalafil 20-40mg qd and Treprostinil Receives: Drug: Treatment group (ambrisentan plus tadalafil plus treprostinil or macitentan plus tadalafil plus treprostinil) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary vascular resistance
Pulmonary vascular resistance measured by right heart catheterization
Measured: 12 months after surgical closure of the defect
Secondary outcomes (12)
Right atrial pressure
The right atrial pressure was measured by the right heart catheterization
Measured: 12 months after surgery
Pulmonary artery pressure
Pulmonary artery pressure measured by the right heart catheterization
Measured: 12 months after surgical closure of the defect
Ratio of pulmonary vascular resistance to systemic vascular resistance
Pulmonary vascular resistance (PVR) and systemic vascular resistance (SVR) were calculated from hemodynamic parameters obtained during right heart catheterization (RHC). PVR was calculated as (mean pulmonary artery pressure - pulmonary artery wedge pressure) divided by cardiac output. SVR was calculated as 80 × (mean arterial pressure - right atrial pressure) divided by cardiac output.
Measured: 12 months after surgical closure of the defect
Cardiac index
Cardiac index was calculated as cardiac output divided by body surface area. Cardiac output was measured during right heart catheterization.
Measured: 12 months after surgical closure of the defect
Mixed venous oxygen saturation
Mixed venous oxygen saturation was sampled and measured from the main pulmonary artery during right heart catheterization.
Measured: 12 months after surgical closure of the defect
Systemic arterial blood oxygen saturation
Systemic arterial blood oxygen saturation was determined from arterial blood samples obtained during right heart catheterization.
Measured: 12 months after surgical closure of the defect
NT-proBNP
Laboratory examination
Measured: 12 months after surgery
6 minutes walking distance
On a flat, hard surface, the maximum distance walked by the subject at their own pace in 6 minutes
Measured: 12 months after surgery
WHO heart function grading
The standard set by the World Health Organization to assess the functional status of patients with heart disease:
Grade I: No limitation in physical activity, no symptoms in daily activities Grade II: Mild limitation of activity, nothing happens when resting, but there will be shortness of breath and fatigue during daily activities.
Level III: Activities are significantly limited, there is no problem when resting, but symptoms will be triggered by slight activities (below daily intensity).
Grade IV: The most severe, symptoms are present at rest and worsen with any activity, and there may be signs of right heart failure.
Measured: 12 months after surgery
The MOS 36-Item Short Form Health Survey (SF-36)
The MOS 36-Item Short Form Health Survey (SF-36) was used to assess health-related quality of life. Each of its eight domains, as well as the physical component summary (PCS) and mental component summary (MCS), ranges from 0 to 100, with higher scores indicating better health status.
Measured: 12 months after surgery
All kinds of adverse events
Rehospitalization due to worsening heart failure, ventricular septal defect repair, lung transplantation or heart-lung transplantation, and other adverse events
Measured: 12 months after surgery
Adverse drug reaction events
Not limited to low blood pressure, headache, muscle soreness, injection site pain,Injection site infection, bleeding, etc.
Measured: 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study start25 Aug 2022
- Primary completion30 Jul 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart Disease, Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yan Wu, China National Center for Cardiovascular Diseases
- Investigators
- Wu Yan, Study director, Fuwai Hospital, National Center for Cardiovascular Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07844213
- Sponsor's protocol ID
- 2021-1639
- Other IDs
- 2021-ZX60
- Status last verified
- Aug 2022
- First submitted
- 30 Aug 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Ethically, raw data contains sensitive personal information, and initial informed consent is often not authorized for external sharing, which may infringe on privacy and violate the trust of participants. From a legal perspective, strict compliance with relevant data protection regulations is required, and there are compliance risks and contractual constraints when transferring data across borders or to third parties. In practice, the establishment of a secure sharing platform is costly, and the degree of data standardization is inconsistent, which may lead to misunderstandings or misuses and affect the credibility of research.
Publications
Baumgartner H, De Backer J, Babu-Narayan SV, Budts W, Chessa M, Diller GP, Lung B, Kluin J, Lang IM, Meijboom F, Moons P, Mulder BJM, Oechslin E, Roos-Hesselink JW, Schwerzmann M, Sondergaard L, Zeppenfeld K; ESC Scientific Document Group. 2020 ESC Guidelines for the management of adult congenital heart disease. Eur Heart J. 2021 Feb 11;42(6):563-645. doi: 10.1093/eurheartj/ehaa554. No abstract available.
PubMed 32860028Skoro-Sajer N, Gerges C, Balint OH, Kohalmi D, Kaldararova M, Simkova I, Jakowitsch J, Gabriel H, Baumgartner H, Gerges M, Sadushi-Kolici R, Celermajer DS, Lang IM. Subcutaneous treprostinil in congenital heart disease-related pulmonary arterial hypertension. Heart. 2018 Jul;104(14):1195-1199. doi: 10.1136/heartjnl-2017-312143. Epub 2018 Feb 7.
PubMed 29436381Thomas IC, Glassner-Kolmin C, Gomberg-Maitland M. Long-term effects of continuous prostacyclin therapy in adults with pulmonary hypertension associated with congenital heart disease. Int J Cardiol. 2013 Oct 9;168(4):4117-21. doi: 10.1016/j.ijcard.2013.07.072. Epub 2013 Jul 25.
PubMed 23890862Rosenzweig EB, Kerstein D, Barst RJ. Long-term prostacyclin for pulmonary hypertension with associated congenital heart defects. Circulation. 1999 Apr 13;99(14):1858-65. doi: 10.1161/01.cir.99.14.1858.
PubMed 10199883Kozlik-Feldmann R, Hansmann G, Bonnet D, Schranz D, Apitz C, Michel-Behnke I. Pulmonary hypertension in children with congenital heart disease (PAH-CHD, PPHVD-CHD). Expert consensus statement on the diagnosis and treatment of paediatric pulmonary hypertension. The European Paediatric Pulmonary Vascular Disease Network, endorsed by ISHLT and DGPK. Heart. 2016 May;102 Suppl 2:ii42-8. doi: 10.1136/heartjnl-2015-308378.
PubMed 27053697Stout KK, Daniels CJ, Aboulhosn JA, Bozkurt B, Broberg CS, Colman JM, Crumb SR, Dearani JA, Fuller S, Gurvitz M, Khairy P, Landzberg MJ, Saidi A, Valente AM, Van Hare GF. 2018 AHA/ACC Guideline for the Management of Adults With Congenital Heart Disease: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019 Apr 2;139(14):e637-e697. doi: 10.1161/CIR.0000000000000602. No abstract available.
PubMed 30586768
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Postoperative Triple Targeted Therapy in Patients With CHD-PAH in the "Grey Zone"
- ClinicalTrials.gov ID
- NCT07844213
- Acronym / sponsor ID
- 2021-1639
- Keywords
- Pulmonary hypertension, Congenital heart disease, Surgical repair, Targeted drug therapy, Prognosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 25 Aug 2022 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 28 Sep 2026 (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.
The purpose of this study is to observe the efficacy of early application of triple targeted drug therapy, including trilostane, in patients with congenital heart disease who are in the "gray zone" of preoperative evaluation, have surgical repair indications after evaluation, and have undergone defect repair.
Detailed description
This study is a prospective randomized controlled study. Including congenital heart disease combined with pulmonary hypertension, the hemodynamics in the right heart catheter before surgery conform to the "gray zone standard" (PVRi: 6-8 Wood * m2) in the 2018 Cologne Consensus.PVR/SVR 0.3-05), acute vascular reaction test met the positive standard (PVRi: < 6 Wood*m 2, PVR/SVR < 0.3), and CHD patients (including VSD, PDA, ASD) who underwent surgical repair, patients were randomly assigned to different treatment groups, The specific grouping is as follows: 1) 15 patients in the standard dual therapy group received dual therapy for 12 months, consisting of a phosphodiesterase type 5 inhibitor (tadalafil 20 mg qd or sildenafil 20~25 mg tid) combined with a phosphodiesterase 5 receptor antagonist (amlodipine 5 mg qd or macitentan 10 mg qd). 2) 15 patients in the early triple therapy group received the combination of a phosphodiesterase type 5 inhibitor (tadalafil 20 mg qd or sildenafil 20~25 mg tid), a phosphodiesterase-5 receptor antagonist (amlodipine 5 mg qd or maropitant 10 mg qd), and treprostinil. The dosage of pralatrexate needs to be titrated gradually, starting from 1.25 ng/min/kg, and titrated gradually to the patient's maximum tolerated dose (guideline dose of 15-20 ng/min/kg), and the duration of triple targeted drug therapy is at least 6 months. After 6 months, it can be adjusted to the standard dual therapy group to 12 months. Observation indexes The main observation indices are as follows:(1) Pulmonary vascular resistance measured by right heart catheterization one year after surgical repair and closure of defects. Secondary observation indicators: (1) Right atrial pressure, pulmonary artery pressure, PVR/SVR, cardiac index, mixed blood oxygen saturation, and systemic arterial blood oxygen saturation measured in right heart catheterization 12 months after surgery. (2) NT-proBNP level (3) 6-minute walk distance (4) WHO functional class (5) SF-36 self-assessment quality of life score (6) rehospitalization due to worsening heart failure, atrial septal defect shunt, lung transplant or heart-lung transplant, and other adverse events; (7) Drug-related adverse reaction events, including but not limited to hypotension, headache, muscle pain, injection site pain, injection site infection, bleeding, etc.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dual therapy group | Active comparator | Drug: Control group (ambrisentan plus tadalafil or macitentan plus tadalafil)Ambrisentan 10mg qd or Macitentan 10mg qd combined with Tadalafil 20-40mg qd |
| Early triple therapy group | Experimental | Drug: Treatment group (ambrisentan plus tadalafil plus treprostinil or macitentan plus tadalafil plus treprostinil)Ambrisentan 10mg qd or Macitentan 10mg qd combined with Tadalafil 20-40mg qd and Treprostinil |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female aged 18 to 65
- Patients with congenital heart disease and pulmonary hypertension with clear diagnosis
- Pulmonary vascular resistance index (PVR) in hemodynamics of right heart catheterization before surgical repair: hemodynamics of right heartcatheterization before surgery conforms to "gray zone standard" (PVR: 4-8 Wood* m2, QP/QS > 1.5), acute vascular reaction test meets the positive standard (PVR: < 4 Wood* m2)
- Successfully performed surgical repair of congenital heart disease to close the defect
- Sign informed consent form
Key exclusion criteria (5 listed)
- Other causes of PAH include pulmonary hypertension associated with left heart disease (valve disease)
- Other types of CHD-PAH, including Eisenmenger syndrome, PAH with small defects, etc.
- After evaluating the acute pulmonary vasodilation test by right heart catheterization, the result shows that the surgical prognosis is poor, and those who are not suitable for surgical treatment should not undergo surgical treatment.
- There are other surgical contraindications, including severe systemic diseases, severe mental disorders, severe cognitive dysfunction, and physical conditions that cannot tolerate surgery.
- Cannot provide informed consent
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 |
|---|---|---|
| Control group (ambrisentan plus tadalafil or macitentan plus tadalafil)The control group received dual drug therapy: endothelin receptor antagonists (Ambrisentan 10mg qd, or Macitentan 10mg qd) combined with phosphodiesterase type 5 inhibitors (Tadalafil 20-40mg qd). | Drug | Dual therapy group |
| Treatment group (ambrisentan plus tadalafil plus treprostinil or macitentan plus tadalafil plus treprostinil)The treatment group received early triple therapy: endothelin receptor antagonist (Ambrisentan 10 mg qd or Macitentan 10 mg qd), a phosphodiesterase type 5 inhibitor ( Tadalafil 20-40 mg qd), and treprostinil. The Treprostinil dose was titrated gradually, starting at 1.25 ng/min/kg and escalated to the patient's maximum tolerated dose (target dose range: 15-20 ng/min/kg). | Drug | Early triple therapy group |
Primary outcome
Pulmonary vascular resistance
Time frame: 12 months after surgical closure of the defect
Pulmonary vascular resistance measured by right heart catheterization
12 secondary outcomes
Right atrial pressure
Time frame: 12 months after surgery
Pulmonary artery pressure
Time frame: 12 months after surgical closure of the defect
Ratio of pulmonary vascular resistance to systemic vascular resistance
Time frame: 12 months after surgical closure of the defect
Cardiac index
Time frame: 12 months after surgical closure of the defect
Mixed venous oxygen saturation
Time frame: 12 months after surgical closure of the defect
Systemic arterial blood oxygen saturation
Time frame: 12 months after surgical closure of the defect
NT-proBNP
Time frame: 12 months after surgery
6 minutes walking distance
Time frame: 12 months after surgery
WHO heart function grading
Time frame: 12 months after surgery
The MOS 36-Item Short Form Health Survey (SF-36)
Time frame: 12 months after surgery
All kinds of adverse events
Time frame: 12 months after surgery
Adverse drug reaction events
Time frame: 12 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Background: PubMed 32860028Baumgartner H, De Backer J, Babu-Narayan SV, Budts W, Chessa M, Diller GP, Lung B, Kluin J, Lang IM, Meijboom F, Moons P, Mulder BJM, Oechslin E, Roos-Hesselink JW, Schwerzmann M, Sondergaard L, Zeppenfeld K; ESC Scientific Document Group. 2020 ESC Guidelines for the management of adult congenital heart disease. Eur Heart J. 2021 Feb 11;42(6):563-645. doi: 10.1093/eurheartj/ehaa554. No abstract available.
- Background: PubMed 29436381Skoro-Sajer N, Gerges C, Balint OH, Kohalmi D, Kaldararova M, Simkova I, Jakowitsch J, Gabriel H, Baumgartner H, Gerges M, Sadushi-Kolici R, Celermajer DS, Lang IM. Subcutaneous treprostinil in congenital heart disease-related pulmonary arterial hypertension. Heart. 2018 Jul;104(14):1195-1199. doi: 10.1136/heartjnl-2017-312143. Epub 2018 Feb 7.
- Background: PubMed 23890862Thomas IC, Glassner-Kolmin C, Gomberg-Maitland M. Long-term effects of continuous prostacyclin therapy in adults with pulmonary hypertension associated with congenital heart disease. Int J Cardiol. 2013 Oct 9;168(4):4117-21. doi: 10.1016/j.ijcard.2013.07.072. Epub 2013 Jul 25.
- Background: PubMed 10199883Rosenzweig EB, Kerstein D, Barst RJ. Long-term prostacyclin for pulmonary hypertension with associated congenital heart defects. Circulation. 1999 Apr 13;99(14):1858-65. doi: 10.1161/01.cir.99.14.1858.
- Background: PubMed 27053697Kozlik-Feldmann R, Hansmann G, Bonnet D, Schranz D, Apitz C, Michel-Behnke I. Pulmonary hypertension in children with congenital heart disease (PAH-CHD, PPHVD-CHD). Expert consensus statement on the diagnosis and treatment of paediatric pulmonary hypertension. The European Paediatric Pulmonary Vascular Disease Network, endorsed by ISHLT and DGPK. Heart. 2016 May;102 Suppl 2:ii42-8. doi: 10.1136/heartjnl-2015-308378.
- Background: PubMed 30586768Stout KK, Daniels CJ, Aboulhosn JA, Bozkurt B, Broberg CS, Colman JM, Crumb SR, Dearani JA, Fuller S, Gurvitz M, Khairy P, Landzberg MJ, Saidi A, Valente AM, Van Hare GF. 2018 AHA/ACC Guideline for the Management of Adults With Congenital Heart Disease: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019 Apr 2;139(14):e637-e697. doi: 10.1161/CIR.0000000000000602. No abstract available.
- Individual participant dataSharing planned: No. Ethically, raw data contains sensitive personal information, and initial informed consent is often not authorized for external sharing, which may infringe on privacy and violate the trust of participants. From a legal perspective, strict compliance with relevant data protection regulations is required, and there are compliance risks and contractual constraints when transferring data across borders or to third parties. In practice, the establishment of a secure sharing platform is costly, and the degree of data standardization is inconsistent, which may lead to misunderstandings or misuses and affect the credibility of research.
Related trials for Congenital Heart Disease, Pulmonary Hypertension
RecruitingObservational study
Natural History of Noncirrhotic Portal Hypertension
Cystic Fibrosis, Immunologic Deficiency Syndrome
Recruiting
Ventilator Pressure and Optimization of Compliance and Hemodynamics
Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia
RecruitingObservational study
Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)
Coronavirus Infection (COVID-19), Pulmonary Arterial Hypertension
Enrolling by invitation
Feasibility of Non-invasive Hemodynamic Assessment by 5D Flow in Congenital Heart Disease
Pulmonary Hypertension, Right Ventricular Outflow Tract Dysfunction
Not yet recruitingObservational study
Measuring Heart Health in Both Term, Preterm and Unwell Newborn Babies With an Advanced Ultrasound Method: Speckle Tracking Echocardiography
Premature Baby, Pulmonary Hypertension of Newborn
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.
Wu Yan study director
Fuwai Hospital, National Center for Cardiovascular Diseases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment group (ambrisentan plus tadalafil plus treprostinil or macitentan plus tadalafil plus treprostinil) in people with Congenital Heart Disease, Pulmonary Hypertension, run by China National Center for Cardiovascular Diseases 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 28 Sep 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 vascular resistance (time frame: 12 months after surgical closure of the defect). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07844213, which also lists 6 linked publications.
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 28 Sep 2026.