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RECRUITINGPhase 4INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

Sirolimus

at a dose of 2 mg once daily

Locations (1)

Tongji Hospital
Wuhan, Hubei, China