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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
Phase
Phase 4
Started
2024-01-01
Last updated
2024-02-01

Condition(s) studied

Dilated CardiomyopathyKaposi's Sarcoma-Associated Herpesvirus Infection

Investigational drug(s) / intervention(s)

Sirolimus →

Sirolimus: at a dose of 2 mg once daily

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

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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)

FacilityCityRegionStatus
Tongji Hospital Wuhan Hubei Recruiting
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