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

RECRUITINGPhase 4Sponsored by Tongji Hospital
Actively Recruiting
PhasePhase 4
SponsorTongji Hospital
Started2024-01-01
Est. completion2028-12-31
Eligibility
Age18 Years – 70 Years
Healthy vol.Accepted

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

Age: 18 Years – 70 YearsHealthy volunteers accepted
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.

Conditions3

Dilated CardiomyopathyHeart DiseaseKaposi's Sarcoma-Associated Herpesvirus Infection

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