Potts-shunt for the Treatment of Pediatric Patients With Severe Pulmonary Hypertension
- Conditions
- Pulmonary Artery Hypertension
- Interventions
- Procedure: Comprehensive therapy combined Potts-shunt procedure and conventional drug therapyDrug: Only conventional drug therapy
- Registration Number
- NCT06429579
- Lead Sponsor
- China National Center for Cardiovascular Diseases
- Brief Summary
This is a multi-center, perspective, and exploratory study aimed at evaluating the 3-years clinical outcome of Potts-shunt procedure for pediatric patients with severe pulmonary artery hypertension (PAH). The included criteria are as followed: 1)6 months \< age ≤ 18 years; 2) ESC 2022 Group I PAH; 3) Have received standardized drug therapy for at least 6-9 months and still remain at intermediate to high/high-risk status of the criteria of ESC2022; 4) Presenting with significant clinical manifestations (i.e., progressive symptoms/syncope history/growth and development restriction, etc); 5) Informed consent form signed by the patient and their guardian. The excluded criteria are as followed: 1) ESC 2022 Group II-V PAH; 2) Poor right ventricular function: RVEF \< 25% or RVFAC \< 20%; 3) Deteriorated general condition: requiring ICU resuscitation or ECMO assistance; 4) Pulmonary artery pressure/main arterial pressure ratio \< 0.7; 5) Six-minute walk distance \< 150 meters (only applicable to patients aged 8 and above); 6) No significant improvement in RVEF under triple drug therapy. All of the pediatric patients with severe PAH who attend to pediatric cardiac outpatient clinic and meet the designed included criteria and excluded criteria will be enrolled in this study. All of the participants will be divided into two groups (Potts-shunt combined with conventional drug therapy group and only conventional drug therapy group) according to their individual health status (i.e., some contraindications of surgery) and their (or their parents') aspiration for Potts-shunts procedure. Follow-up is designed (eight-times follow-up) at the time of Potts-shunt procedure, post-operative ICU period, one month, three months, six months, one year, two years, and three years after Potts-shunt procedure or the rejection of Potts-shunt procedure. The items of follow-up include state of survival, whether or not have the lung transplantation (LTx), clinical manifestation, laboratory examination, function of right ventricle (detected by echocardiogram and cardiac magnetic resonance imaging), and the pulmonary circulation pressure (detected by right heart catheterization or Swan-Ganz catheterization). Primary outcome is the incidence rates of death or LTx three-years after Potts-shunt. Secondary outcomes are as followed: 1) Number and incidence rate of postoperative complications in patients undergoing Potts-shunt procedure; 2) Three-year WHO cardiac functional and 6-minute walk distance after Potts-shunt procedure; 3) the NT-ProBNP levels three-years after Potts-shunt procedure; 4) Right ventricular function on echocardiography three years after Potts-shunt procedure; 5) Right ventricular function on cardiac magnetic resonance imaging three years after Potts-shunt procedure; 6) Pulmonary circulation pressure measured by right heart catheterization or Swan-Ganz catheterization three years after Potts-shunt procedure; 7) Three-year mortality or LTx incidence rates after only conventional drug therapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
- 6 months < age ≤ 18 years;
- ESC 2022 Group I PAH;
- Have received standardized drug therapy for at least 6-9 months and still remain at intermediate to high/high-risk status of the criteria of ESC2022;
- Presenting with significant clinical manifestations (i.e., progressive symptoms/syncope history/growth and development restriction, etc);
- Informed consent form signed by the patient and their guardian.
- ESC 2022 Group II-V PAH;
- Poor right ventricular function: RVEF < 25% or RVFAC < 20%;
- Deteriorated general condition: requiring ICU resuscitation or ECMO assistance;
- Pulmonary artery pressure/main arterial pressure ratio < 0.7;
- Six-minute walk distance < 150 meters (only applicable to patients aged 8 and above);
- No significant improvement in RVEF under triple drug therapy.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Potts-shunt combined with conventional drug therapy group Comprehensive therapy combined Potts-shunt procedure and conventional drug therapy The comprehensive therapy included Potts-shunt procedure and conventional drug therapy (i.e., Prostacyclin analogues, PDE-5 inhibitors, and Endothelin receptor antagonists) Only conventional drug therapy group Only conventional drug therapy Only admitted with conventional drug therapy (i.e., Prostacyclin analogues, PDE-5 inhibitors, and Endothelin receptor antagonists)
- Primary Outcome Measures
Name Time Method Mortality or Lung transplantation From the date of enrollment until the date of dear from any cause or lung transplantation, which ever came first, accessed up to 3 years The incidence rates of death or lung transplantation 3 years after Potts-shunt, accessed by in-patient, out-patient, or telephone follow-up
- Secondary Outcome Measures
Name Time Method NT-ProBNP levels after Potts-shunt procedure From the date of enrollment to the date of every view-point, assessed up to 3 years NT-ProBNP (pg/ml) accessed by laboratory test
The 6-minutes distance after Potts-shunt procedure From the date of enrollment to the date of every view-point, assessed up to 3 years The 6-minutes distance (meter) was designed to measure activity tolerance, accessed by pediatric doctors or parents of participants.
Number and incidence rate of postoperative complications in patients undergoing Potts-shunt procedure From the date of enrollment to the date of any postoperative complications, whichever came first, accessed up to 3 years Postoperative complications include hemoptysis, syncope, pulmonary hypertension crisis, low blood oxygen in the lower extremities etc. accessed by pediatric ICU doctors.
Right ventricular function on echocardiography after Potts-shunt procedure From the date of enrollment to the date of every view-point, assessed up to 3 years The RVFAC (%) accessed by echocardiography
Pulmonary circulation pressure measured by right heart catheterization or Swan-Ganz catheterization after Potts-shunt procedure From the date of enrollment to the date of every view-point, assessed up to 3 years SPAP, DPAP, MPAP (mmHg) etc. accessed by right heart catheterization or Swan-Ganz catheterization
Mortality or lung transplantation incidence rates after only conventional drug therapy From the date of enrollment until the date of dear from any cause or lung transplantation, which ever came first, accessed up to 3 years The incidence rates of death or lung transplantation 3 years after enrollment
World Health Organization functional class (WHO-FC) after Potts-shunt procedure From the date of enrollment to the date of every view-point, assessed up to 3 years WHO-FC was designed to measure the severity of pulmonary hypertension based on symptoms of dyspnea, fatigue, chest pain, and related syncope, accessed by the pediatric doctors.
Right ventricular function on cardiac magnetic resonance imaging after Potts-shunt procedure From the date of enrollment to the date of every view-point, assessed up to 3 years The RVEF (%) accessed by cardiac MRI
Trial Locations
- Locations (1)
Pediatric cardic surgical center, Fuwai Hospital
🇨🇳Beijing, Beijing, China