To hear about similar clinical trials, please enter your email below
Trial Title:
The Effects of Sirolimus in Patients With Dilated Cardiomyopathy Infected With Kaposi Sarcoma-associated Virus
NCT ID:
NCT06236022
Condition:
Dilated Cardiomyopathy
Kaposi's Sarcoma-Associated Herpesvirus Infection
Conditions: Official terms:
Sarcoma, Kaposi
Herpesviridae Infections
Sarcoma
Cardiomyopathies
Cardiomyopathy, Dilated
Sirolimus
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Sirolimus
Description:
at a dose of 2 mg once daily
Arm group label:
Sirolimus
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.
Detailed 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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Tongji Hospital
Address:
City:
Wuhan
Zip:
430030
Country:
China
Status:
Recruiting
Contact:
Last name:
Yanru Zhao, Doctor
Phone:
86-027-83663280
Email:
zyrecho@163.com
Start date:
January 1, 2024
Completion date:
December 31, 2028
Lead sponsor:
Agency:
Tongji Hospital
Agency class:
Other
Collaborator:
Agency:
Wuhan Central Hospital
Agency class:
Other
Collaborator:
Agency:
Wuhan Fourth Hospital
Agency class:
Other
Collaborator:
Agency:
Wuhan University
Agency class:
Other
Source:
Tongji Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06236022
