Clinical Trials in China / NCT06236022
Recruiting
Phase 4
The Effects of Sirolimus in Patients With Dilated Cardiomyopathy Infected With Kaposi Sarcoma-associated Virus
NCT06236022 · tracked via the Priya Life Science China tracker
Condition(s) studied
Dilated CardiomyopathyKaposi's Sarcoma-Associated Herpesvirus Infection
Study 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
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 patients);
* Previous history of cancer or tumor, or pathological examination confirmed precancerous lesions;
* Patients were not optimally managed.
Primary outcome measure(s)
- Cardiac mortality — up to 36 months
Death from cardiovascular disease which includes coronary artery diseases, stroke, heart failure, hypertensive heart disease, rheumatic heart disease, cardiomyopathy, heart arrhythmia, congenital heart disease, valvular heart disease and carditis - Rate of heart transplantation — up to 36 months
The rate of heart trans plantation on patients with DCM when other medical or surgical treatments have failed
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Tongji Hospital | Wuhan | Hubei | Recruiting |
More Tongji Hospital trials in China
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06236022 on ClinicalTrials.gov ↗ ← All trials in China