NCT06236022

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
276

participants targeted

Target at P75+ for phase_4

Timeline
32mo left

Started Jan 2024

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress47%
Jan 2024Dec 2028

Study Start

First participant enrolled

January 1, 2024

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

January 24, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 1, 2024

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

February 1, 2024

Status Verified

January 1, 2024

Enrollment Period

5 years

First QC Date

January 24, 2024

Last Update Submit

January 24, 2024

Conditions

Dilated CardiomyopathyKaposi's Sarcoma-Associated Herpesvirus Infection

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    up to 36 months

Secondary Outcomes (4)

  • Readmission rate for cardiovascular diseases

    up to 36 months

  • Recurrence rate of heart failure

    up to 36 months

  • All-cause mortality

    up to 36 months

  • KCCQ score

    up to 36 months

Study Arms (2)

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

Drug: Sirolimus

Interventions

SirolimusDRUG

at a dose of 2 mg once daily

Sirolimus

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430030, China

RECRUITING

MeSH Terms

Conditions

Cardiomyopathy, Dilated

Interventions

Sirolimus

Condition Hierarchy (Ancestors)

CardiomegalyHeart DiseasesCardiovascular DiseasesCardiomyopathiesLaminopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • Dao Wen Wang, Doctor

    Tongji Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanru Zhao, Doctor

CONTACT

86-027-83663280zyrecho@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

January 24, 2024

First Posted

February 1, 2024

Study Start

January 1, 2024

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

February 1, 2024

Record last verified: 2024-01

Locations

CN(1)