Clinical trial · Interventional
The Effects of Sirolimus in Patients With Dilated Cardiomyopathy Infected With Kaposi Sarcoma-associated Virus
NCT06236022CI-TRIAL-00073522SDCMKrecruitingPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Dilated Cardiomyopathy | — | UNRESOLVED | — |
| Kaposi's Sarcoma-Associated Herpesvirus Infection | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sirolimus | Drug | Sirolimus | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control
- description
- patients with dilated cardiomyopathy infected with Kaposi sarcoma-associated virus to receive standard DCM therapy
- type
- EXPERIMENTAL
- label
- Sirolimus
- description
- patients with dilated cardiomyopathy infected with Kaposi sarcoma-associated virus to receive sirolimus (at a dose of 2 mg once daily) in addition to standard DCM therapy
- interventionNames
- Drug: Sirolimus
Primary outcomes (2)
- measure
- Cardiac mortality
- timeFrame
- up to 36 months
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.