Acquired pulmonary venous obstruction
Conditions
Interventions
losartan group:oral losartan
control group:Not taking losartan
Sponsors
Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
No minimum to 18 Years
Inclusion criteria
Inclusion criteria: 1. Provision of signed and dated informed consent form (Stated willingness to comply with all study procedures and availability for the duration of the study); 2. Children under 18 years old, regardless of gender; 3. After TAPVC surgery, echocardiography showed that the anastomotic or pulmonary vein branch flow rate> 1.8m/s was the population with postoperative PVS; 4. The preoperative color Doppler ultrasound indicated that the left ventricular ejection fraction (LVEF) was >= 50%; 5. Ability to take oral medication and be willing to adhere to the study intervention regimen 6. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 2 years after the end of the study intervention administration; 7. For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner; 8. Abstain from strenuous exercise for 2 years after surgery. Participants may participate in light recreational activities during studies (e.g., watching television, reading); 9. Abstain from caffeine-,nicotine-, or alcohol-containing products for 2 yeras after surgery.
Exclusion criteria
Exclusion criteria: 1. Patients who are using angiotensin receptor antagonist drugs; 2. Patients with contraindications to losartan; 3. History of angioedema or allergic reaction to angiotensin converting enzyme inhibitors; 4. Severe hepatic or renal dysfunction; 5. Patients in remote areas with low follow-up rates; 6. Pregnancy or lactation; 7. Current smoker.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relief of pulmonary vein stenosis;survival;adverse event rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| blood endothelin content;CT-based computational hemodynamic indexs (such as shear stress distribution, etc.);NYHA grade;ECG;blood routine;liver and kidney function;Blood B-type natriuretic peptide;Troponin;chest radiograph;cardiac ultrasound;heart rate;heart rhythm;blood pressure;blood oxygen saturation;blood gas analysis; | — |
Countries
China
Contacts
Public ContactHuiwen Chen
Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed