The Effects of Sirolimus in Patients With Dilated Cardiomyopathy Infected With Kaposi Sarcoma-associated Virus

Dilated Cardiomyopathy Clinical Trial

— SDCMK  

Official title:

The Effects of Sirolimus in Patients With Dilated Cardiomyopathy Infected With Kaposi Sarcoma-associated Virus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06236022
• Other study ID #: TJH-SDCMK
• Status: Recruiting
• Phase: Phase 4
• 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
• 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.

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Dilated
• Dilated Cardiomyopathy
• Herpesviridae Infections
• Sarcoma
• Sarcoma, Kaposi

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