Dilated CardiomyopathyPhase 4SDCMKNCT06236022
The Effects of Sirolimus in Patients With Dilated Cardiomyopathy Infected With Kaposi Sarcoma-associated Virus
A Phase 4 study testing Sirolimus in people with Dilated Cardiomyopathy and Kaposi's Sarcoma-Associated Herpesvirus Infection, run by Tongji Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Dilated Cardiomyopathy, Kaposi's Sarcoma-Associated Herpesvirus Infection
- What is being tested?
- Sirolimus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 31 Dec 2028
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital
Wuhan, Hubei, 430030
Yanru Zhao, Doctor, 86-027-83663280, zyrecho@163.com
About this study
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.
Read the 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.
- Being tested
- Sirolimus
- Medical subject headings
- Cardiomyopathy, Dilated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SirolimusDrug
at a dose of 2 mg once daily
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | patients with dilated cardiomyopathy infected with Kaposi sarcoma-associated virus to receive standard DCM therapy |
| Sirolimus | Experimental | 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 Receives: Drug: Sirolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac mortality
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
Measured: up to 36 months
Rate of heart transplantation
The rate of heart trans plantation on patients with DCM when other medical or surgical treatments have failed
Measured: up to 36 months
Secondary outcomes (4)
Readmission rate for cardiovascular diseases
The readmission rate for cardiovascular diseases
Measured: up to 36 months
Recurrence rate of heart failure
The recurrence rate of heart failure
Measured: up to 36 months
All-cause mortality
Death from all diseases
Measured: up to 36 months
KCCQ score
The score of patients measured with the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start1 Jan 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dilated CardiomyopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 276 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Wuhan Central Hospital, Wuhan Fourth Hospital, Wuhan University
- Responsible party
- Principal investigator, Dao Wen Wang, Tongji Hospital
- Investigators
- Dao Wen Wang, Doctor, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06236022
- Sponsor's protocol ID
- TJH-SDCMK
- Acronym
- SDCMK
- Status last verified
- Jan 2024
- First submitted
- 24 Jan 2024
- Last updated
- 1 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No