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

Completed

• Conditions: Systemic Lupus Erythematosus

• Registration Number: NCT05146414
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study Start: 2007-07-10
• Primary Completion: 2018-01-23
• Study Completion: 2021-02-10
• Status Verified: 2021-10
• Study First Submitted: 2021-11-25
• Study First Submitted QC: 2021-11-25
• Last Update Submitted: 2021-11-25
• Study First Posted: 2021-12-06
• Last Update Posted: 2021-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Prevalence of CHIP in SLE	at PLUS inclusion

Trial Locations

Locations (1)

Hôpital Bichat; 🇫🇷 Paris, France