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Completed NCT07844213

Early Postoperative Triple Targeted Therapy in Patients With CHD-PAH in the "Grey Zone"

Conditions: Congenital Heart Disease, Pulmonary Hypertension

Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 30
Sponsor: China National Center for Cardiovascular Diseases

Location: Fuwai Hospital, National Center for Cardiovascular Diseases Beijing

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.

Eligibility Criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07844213). StuddyBuddy aggregates publicly available trial information.