Dilated Cardiomyopathy Clinical Trial
— SDCMKOfficial title:
The Effects of Sirolimus in Patients With Dilated Cardiomyopathy Infected With Kaposi Sarcoma-associated Virus
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.
Status | Recruiting |
Enrollment | 276 |
Est. completion date | December 31, 2028 |
Est. primary completion date | December 31, 2028 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Tongji Hospital | Wuhan | Hubei |
Lead Sponsor | Collaborator |
---|---|
Tongji Hospital | Wuhan Central Hospital, Wuhan Fourth Hospital, Wuhan University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | up to 36 months | |
Primary | Rate of heart transplantation | The rate of heart trans plantation on patients with DCM when other medical or surgical treatments have failed | up to 36 months | |
Secondary | Readmission rate for cardiovascular diseases | The readmission rate for cardiovascular diseases | up to 36 months | |
Secondary | Recurrence rate of heart failure | The recurrence rate of heart failure | up to 36 months | |
Secondary | All-cause mortality | Death from all diseases | up to 36 months | |
Secondary | KCCQ score | The score of patients measured with the Kansas City Cardiomyopathy Questionnaire (KCCQ) | up to 36 months |
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