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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Tongji Hospital
  Wuhan, Hubei, China Recruiting

Study contacts

• Principal investigator: Dao Wen Wang, Doctor — Tongji Hospital
• Study coordinator: Yanru Zhao, Doctor
• Email: zyrecho@163.com
• Phone: 86-027-83663280

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.