Trials
Search / Trial NCT06429579

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

Launched by CHINA NATIONAL CENTER FOR CARDIOVASCULAR DISEASES · May 23, 2024

Trial Information

Current as of February 19, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a procedure called the Potts-shunt, which is being explored as a treatment for children and teenagers with severe pulmonary artery hypertension (PAH). PAH is a serious condition where the blood pressure in the lungs is too high, which can cause significant health problems. The trial aims to see how effective the Potts-shunt procedure is over three years compared to standard drug therapy alone. To participate, patients must be between 6 months and 18 years old, have a specific type of PAH, and have already tried medication for at least 6 to 9 months without enough improvement.

Participants in the trial will be grouped based on their health status and preferences regarding the Potts-shunt procedure. They will receive regular follow-ups at various time points after the procedure, during which their health, including heart function and lung pressure, will be monitored. The main focus is on survival rates and whether participants need a lung transplant. This study is currently recruiting participants, and it offers a chance for young patients with severe PAH to explore a potential new treatment option while contributing to important medical research.

Gender

ALL

Eligibility criteria

  • 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.

About China National Center For Cardiovascular Diseases

The China National Center for Cardiovascular Diseases (NCCD) is a leading research and clinical trial sponsor dedicated to advancing cardiovascular health in China and globally. As a prominent institution, NCCD focuses on innovative research, clinical management, and education in cardiovascular medicine. The center plays a crucial role in conducting rigorous clinical trials aimed at developing new therapies and improving patient outcomes for cardiovascular diseases. Through collaboration with national and international partners, NCCD is committed to enhancing the understanding of cardiovascular conditions and translating research findings into practical applications for improved healthcare.

Locations

Beijing, Beijing, China

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0