HEMATOPLUS: Clonal Hematopoiesis of Indeterminate Potential and Accelerated Atherosclerosis in Systemic Lupus Erythematosus
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
Outcome Measures
Primary Outcome Measures
- 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
- Prevalence of CHIP in SLE [at PLUS inclusion]
Eligibility Criteria
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
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.- CRC18058