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Clinical Trials/NCT05146414
NCT05146414
Completed
Not Applicable

Clonal Hematopoiesis of Indeterminate Potential and Accelerated Atherosclerosis in Patients With Systemic Lupus Erythematosus

Assistance Publique - Hôpitaux de Paris1 site in 1 country500 target enrollmentJuly 10, 2007

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Systemic Lupus Erythematosus
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrollment
500
Locations
1
Primary Endpoint
The primary outcome was the occurrence of cardiovascular events (CVE) over follow-up.
Status
Completed
Last Updated
4 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
July 10, 2007
End Date
February 10, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

The primary outcome was the occurrence of cardiovascular events (CVE) over follow-up.

Time Frame: >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 Outcomes

  • Prevalence of CHIP in SLE(at PLUS inclusion)

Study Sites (1)

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