HEMATOPLUS: Clonal Hematopoiesis of Indeterminate Potential and Accelerated Atherosclerosis in Systemic Lupus Erythematosus

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Completed
CT.gov ID
NCT05146414
Collaborator
Pr Nathalie COSTEDOAT-CHALUMEAU (Other)
500
1
163.1
3.1

Study Details

Study Description

Brief Summary

Accelerated atherosclerosis in patients with systemic lupus erythematosus (SLE) is not fully explained by Framingham risk factors. The detection in asymptomatic patients of somatic mutations in genes involved in hematopoietic malignancy- defining clonal hematopoiesis of indeterminate potential (CHIP) - predisposes to cardiovascular events (CVE) in general population. We aimed to determine whether CHIP is associated with CVE in SLE.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    SLE patients indeed display an accelerated atherosclerosis that strongly contributes to the excess mortality observed but is poorly explained by the traditional cardiovascular risk factors. Clonal hematopoiesis defines the clonal expansion of hematopoietic cells driven by a selective advantage given by leukemia-associated somatic mutations. Clonal hematopoiesis is said of indeterminate potential (CHIP) when found in asymptomatic patient. CHIP strongly correlated with age and logically predispose to haematological malignancy, but is also causally associated with cardiovascular events (CVE) in the general population. The main objective of our study was to determine whether CHIP is associated with CVE in SLE patients.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Clonal Hematopoiesis of Indeterminate Potential and Accelerated Atherosclerosis in Patients With Systemic Lupus Erythematosus
    Actual Study Start Date :
    Jul 10, 2007
    Actual Primary Completion Date :
    Jan 23, 2018
    Actual Study Completion Date :
    Feb 10, 2021

    Outcome Measures

    Primary Outcome Measures

    1. The primary outcome was the occurrence of cardiovascular events (CVE) over follow-up. [>20 months after PLUS inclusion]

      Incidents CVE were ascertained by physician interview using a standardized questionnaire and through examination of medical records. CVE included coronary heart disease, stroke, revascularization procedure for other atherosclerotic cardiovascular diseases and sudden cardiac death. Coronary heart disease was defined as a history of angina, coronary revascularization, or myocardial infarction. All CVE that occurred through March 2019 were considered for analysis

    Secondary Outcome Measures

    1. Prevalence of CHIP in SLE [at PLUS inclusion]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patient with a systemic lupus erythematosus
    Exclusion Criteria:
    • Inadequate follow-up period (< 20 months) -past history of CVE at baseline for inclusion in the TROPOPLUS study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hôpital Bichat Paris France 75018

    Sponsors and Collaborators

    • Assistance Publique - Hôpitaux de Paris
    • Pr Nathalie COSTEDOAT-CHALUMEAU

    Investigators

    • Principal Investigator: Karim SACRE, MD,PhD, Assistance Publique - Hôpitaux de Paris

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Assistance Publique - Hôpitaux de Paris
    ClinicalTrials.gov Identifier:
    NCT05146414
    Other Study ID Numbers:
    • CRC18058
    First Posted:
    Dec 6, 2021
    Last Update Posted:
    Dec 6, 2021
    Last Verified:
    Oct 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Assistance Publique - Hôpitaux de Paris
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 6, 2021