The Effects of Sirolimus in Patients With Dilated Cardiomyopathy Infected With Kaposi Sarcoma-associated Virus
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-70
SponsorTongji Hospital
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Sirolimus
Treatment groups
276 Participants
are divided into 2 treatment groupsSponsors and collaborators
Tongji Hospital
Lead sponsor
Wuhan Central Hospital
Collaborator
Wuhan Fourth Hospital
Collaborator
Wuhan University
Collaborator
Source ClinicalTrials.gov