The Effects of Sirolimus in Patients With Dilated Cardiomyopathy Infected With Kaposi Sarcoma-ass⦠(NCT06236022) | Clinical Trial Compass
RecruitingPhase 4
The Effects of Sirolimus in Patients With Dilated Cardiomyopathy Infected With Kaposi Sarcoma-associated Virus
China276 participantsStarted 2024-01-01
Plain-language 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.
Who can participate
Age range18 Years ā 70 Years
SexALL
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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 derivativesļ¼
* 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.