NCT06236022RecruitingPhase 4
The Effects of Sirolimus in Patients With Dilated Cardiomyopathy Infected With Kaposi Sarcoma-associated Virus
Source: ClinicalTrials.gov · Last updated 1 Feb 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 276 (estimated)
- First submitted
- 24 Jan 2024
- Start date
- 1 Jan 2024
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Tongji Hospital
- Diseases
- Sarcoma
- NCT number
- NCT06236022
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 276
- From 1 Jan 2024 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participate in any drug clinical trials within 3 months;
Other illness
- Allergic to rapamycin or its derivatives;
- 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;
Lab values
- The proportion of neutrophils less than 0.5\*10\^9/L or platelet less than 2.5\*10\^10/L;
Other
- Pregnant women or plan to;
- Patients were not optimally managed.
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tongji Hospital Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.