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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Sirolimus
Drugat a dose of 2 mg once daily
Treatment groups
276 Participants
are divided into 2 treatment groupsGroup A: ControlNo intervention 0 interventions
Group B: SirolimusExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Cardiac mortality
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
Time frame
up to 36 months2
Rate of heart transplantation
The rate of heart trans plantation on patients with DCM when other medical or surgical treatments have failed
Time frame
up to 36 monthsSecondary outcomes
1
Readmission rate for cardiovascular diseases
The readmission rate for cardiovascular diseases
Time frame
up to 36 months2
Recurrence rate of heart failure
The recurrence rate of heart failure
Time frame
up to 36 months3
All-cause mortality
Death from all diseases
Time frame
up to 36 months4
KCCQ score
The score of patients measured with the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time frame
up to 36 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Tongji Hospital
Lead sponsor
Wuhan Central Hospital
Collaborator
Wuhan Fourth Hospital
Collaborator
Wuhan University
Collaborator
Source ClinicalTrials.gov