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

Launched by TONGJI HOSPITAL · Jan 24, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called sirolimus in patients who have dilated cardiomyopathy and are infected with a virus known as Kaposi Sarcoma-associated herpesvirus. Dilated cardiomyopathy is a condition where the heart becomes enlarged and weakened, making it harder for it to pump blood. The trial aims to see if sirolimus can improve the heart's function better than the standard treatment alone.

To participate in this study, individuals need to be between 18 and 70 years old and have a confirmed diagnosis of dilated cardiomyopathy, along with a positive test for the Kaposi Sarcoma-associated virus. Participants will be randomly assigned to receive either sirolimus or standard therapy and will be monitored throughout the trial. It’s important to note that those who have certain allergies, serious health issues, or significant blood count problems cannot participate. This trial is currently looking for volunteers, so if you or someone you know fits the criteria and is interested, it could be a valuable opportunity to contribute to medical research.

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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 patients);
• • Previous history of cancer or tumor, or pathological examination confirmed precancerous lesions;
• • Patients were not optimally managed.