Effects of Sirolimus on Heart Disease in Patients with a Specific Virus

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

This study is testing if the drug sirolimus can help improve heart health in patients with dilated cardiomyopathy who are also infected with a specific virus.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 276 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Tongji Hospital (other)
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT06236022 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy of sirolimus, an mTOR inhibitor, in treating dilated cardiomyopathy (DCM) in patients infected with Kaposi Sarcoma-associated virus (KSHV). It is a multicenter randomized controlled trial comparing sirolimus treatment to standard therapy alone. DCM is characterized by poor cardiovascular outcomes, and KSHV infection is believed to exacerbate this condition through inflammatory mechanisms. The study aims to provide evidence for the clinical application of sirolimus in this patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 diagnosed with dilated cardiomyopathy and KSHV DNA seropositivity.

Not a fit: Patients with severe coronary artery disease, valvular disease, or those allergic to rapamycin or its derivatives may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve heart function and overall health outcomes for patients with DCM infected by KSHV.

How similar studies have performed: While the specific combination of sirolimus for DCM and KSHV is novel, mTOR inhibitors have shown promise in treating other viral infections and related conditions.

Eligibility criteria

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.

Where this trial is running

Wuhan, Hubei

• Tongji Hospital — Wuhan, Hubei, China (RECRUITING)

Study contacts

• Principal investigator: Dao Wen Wang, Doctor — Tongji Hospital
• Study coordinator: Yanru Zhao, Doctor

Conditions: Dilated Cardiomyopathy, Kaposi's Sarcoma-Associated Herpesvirus Infection