Potts-shunt for the Treatment of Pediatric Patients With Severe Pulmonary Hypertension

Pulmonary Artery Hypertension Clinical Trial

Official title:

Multicenter, Prospective, and Exploratory Study of Potts-shunt for the Treatment of Pediatric Patients With Severe Pulmonary Hypertension

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06429579
• Other study ID #: NCRC2024001
• Status: Recruiting
• Phase: N/A
• Start date: April 23, 2024
• Est. completion date: April 23, 2029

Study information

• Verified date: April 2024
• Source: China National Center for Cardiovascular Diseases
• Contact: Shoujun Li, MD
• Phone: +8613501071589
• Email: drlishoujunfw[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: April 23, 2029
• Est. primary completion date: April 23, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 18 Years

Eligibility

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Arterial Hypertension
• Pulmonary Artery Hypertension

Intervention

Procedure:
• Comprehensive therapy combined Potts-shunt procedure and conventional drug therapy
Potts-shunt procedure is the surgery that connect the descending aorta and the left/main pulmonary artery by direct anastomosis, a Gore-tex tube or a Gore-tex tube with flap.

Drug:
• Only conventional drug therapy
Only conventional drug therapy (i.e., Prostacyclin analogues, PDE-5 inhibitors, and Endothelin receptor antagonists)

Locations

Country	Name	City	State
China	Pediatric cardic surgical center, Fuwai Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality or Lung transplantation	The incidence rates of death or lung transplantation 3 years after Potts-shunt, accessed by in-patient, out-patient, or telephone follow-up	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
Secondary	Number and incidence rate of postoperative complications in patients undergoing Potts-shunt procedure	Postoperative complications include hemoptysis, syncope, pulmonary hypertension crisis, low blood oxygen in the lower extremities etc. accessed by pediatric ICU doctors.	From the date of enrollment to the date of any postoperative complications, whichever came first, accessed up to 3 years
Secondary	World Health Organization functional class (WHO-FC) after Potts-shunt procedure	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.	From the date of enrollment to the date of every view-point, assessed up to 3 years
Secondary	NT-ProBNP levels after Potts-shunt procedure	NT-ProBNP (pg/ml) accessed by laboratory test	From the date of enrollment to the date of every view-point, assessed up to 3 years
Secondary	Right ventricular function on cardiac magnetic resonance imaging after Potts-shunt procedure	The RVEF (%) accessed by cardiac MRI	From the date of enrollment to the date of every view-point, assessed up to 3 years
Secondary	Right ventricular function on echocardiography after Potts-shunt procedure	The RVFAC (%) accessed by echocardiography	From the date of enrollment to the date of every view-point, assessed up to 3 years
Secondary	Pulmonary circulation pressure measured by right heart catheterization or Swan-Ganz catheterization after Potts-shunt procedure	SPAP, DPAP, MPAP (mmHg) etc. accessed by right heart catheterization or Swan-Ganz catheterization	From the date of enrollment to the date of every view-point, assessed up to 3 years
Secondary	Mortality or lung transplantation incidence rates after only conventional drug therapy	The incidence rates of death or lung transplantation 3 years after enrollment	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
Secondary	The 6-minutes distance after Potts-shunt procedure	The 6-minutes distance (meter) was designed to measure activity tolerance, accessed by pediatric doctors or parents of participants.	From the date of enrollment to the date of every view-point, assessed up to 3 years