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Recruiting Phase 4 NCT06236022

The Effects of Sirolimus in Patients With Dilated Cardiomyopathy Infected With Kaposi Sarcoma-associated Virus

Trial Parameters

Condition Dilated Cardiomyopathy
Sponsor Tongji Hospital
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 276
Sex ALL
Min Age 18 Years
Max Age 70 Years
Start Date 2024-01-01
Completion 2028-12-31
Interventions
Sirolimus

Brief Summary

Evaluating the efficacy of sirolimus (compared to standard therapy alone) in the treatment of dilated cardiomyopathy infected with Kaposi Sarcoma-associated virus -- a multicenter randomized controlled study.

Eligibility Criteria

Inclusion Criteria: * 18 to 70 years of age; * Diagnosed as dilated cardiomyopathy. Specifically, (i) left ventricular ejection fraction \<45% (\>2 SD) and/or fractional shortening \<25% (\>2 SD), as ascertained by echocardiography, radionuclide scanning, or cardiac magnetic resonance imaging; (ii) left ventricular end-diastolic diameter \>117% of the predicted value corrected for age and body surface area (Henry's formula), which corresponds to 2 SD of the predicted normal limit +5%; and (iii) In the absence of severe coronary artery disease or valvular disease. * KSHV DNA seropositivity; * Patients are voluntary and signed informed consent. Exclusion Criteria: * Allergic to rapamycin or its derivatives; * The proportion of neutrophils less than 0.5\*10\^9/L or platelet less than 2.5\*10\^10/L; * Pregnant women or plan to; * Participate in any drug clinical trials within 3 months; * Serious neurological disease (Alzheimer's disease, Parkinson syndrome, progressive lower limbs or deaf

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