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

Last updated: January 24, 2024
Sponsor: Tongji Hospital
Overall Status: Active - Recruiting

Phase

4

Condition

Sarcoma

Heart Defect

Congestive Heart Failure

Treatment

Sirolimus

Clinical Study ID

NCT06236022
TJH-SDCMK
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 18 to 70 years of age;
  • Diagnosed as dilated cardiomyopathy. Specifically, (i) left ventricular ejectionfraction <45% (>2 SD) and/or fractional shortening <25% (>2 SD), as ascertained byechocardiography, radionuclide scanning, or cardiac magnetic resonance imaging; (ii)left ventricular end-diastolic diameter >117% of the predicted value corrected for ageand body surface area (Henry's formula), which corresponds to 2 SD of the predictednormal limit +5%; and (iii) In the absence of severe coronary artery disease orvalvular disease.
  • KSHV DNA seropositivity;
  • Patients are voluntary and signed informed consent.

Exclusion

Exclusion Criteria:

  • Allergic to rapamycin or its derivatives；
  • The proportion of neutrophils less than 0.510^9/L or platelet less than 2.510^10/L;
  • Pregnant women or plan to;
  • Participate in any drug clinical trials within 3 months;
  • Serious neurological disease (Alzheimer's disease, Parkinson syndrome, progressivelower limbs or deaf patients);
  • Previous history of cancer or tumor, or pathological examination confirmedprecancerous lesions;
  • Patients were not optimally managed.

Study Design

Total Participants: 276
Treatment Group(s): 1
Primary Treatment: Sirolimus
Phase: 4
Study Start date:
January 01, 2024
Estimated Completion Date:
December 31, 2028

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.

Connect with a study center

  • Tongji Hospital

    Wuhan, Hubei 430030
    China

    Active - Recruiting

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