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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06236022
Other study ID # TJH-SDCMK
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date January 1, 2024
Est. completion date December 31, 2028

Study information

Verified date January 2024
Source Tongji Hospital
Contact Yanru Zhao, Doctor
Phone 86-027-83663280
Email zyrecho@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Dilated cardiomyopathy (DCM), defined as left ventricular or biventricular dilation and systolic dysfunction in the absence of either pressure or volume overload or coronary artery disease sufficient to explain the dysfunction, is associated with poor cardiovascular outcome and poor prognosis. Inflammation, activated by viral persistence, was considered as a key trigger factor of cardiac remodeling and thereby the development of DCM. As a risk factor for DCM, Kaposi's sarcoma-associated herpes virus (KSHV) inhibits the type I IFN signaling pathway and thereby aggravates known cardiotropic viruses-induced cardiac dysfunction and inflammatory infiltration. Activated mTOR signaling pathway is a typical feature of KSHV-infected cells, which is the most effective therapeutic target of diseases caused by KSHV infection. Sirolimus, a mTOR inhibitor, is a drug that can effectively treat the KSHV-infected diseases and suppresses the replication of KSHV.Therefore, multicenter large randomized controlled trials are needed to verify the efficacy of sirolimus on patients with DCM infected with KSHV. This study aimed to evaluate the effiects of sirolimus on the clinical outcomes of patients with DCM infected with KSHV and provide theoretical evidence for the clinical application of sirolimus in these patients.


Recruitment information / eligibility

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.

Study Design


Intervention

Drug:
Sirolimus
at a dose of 2 mg once daily

Locations

Country Name City State
China Tongji Hospital Wuhan Hubei

Sponsors (4)

Lead Sponsor Collaborator
Tongji Hospital Wuhan Central Hospital, Wuhan Fourth Hospital, Wuhan University

Country where clinical trial is conducted

China, 

Outcome

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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