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

Systemic Lupus Erythematosus Clinical Trial

— HEMATOPLUS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05146414
• Other study ID #: CRC18058
• Status: Completed
• Start date: July 10, 2007
• Est. completion date: February 10, 2021

Study information

• Verified date: October 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: February 10, 2021
• Est. primary completion date: January 23, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Locations

Country	Name	City	State
France	Hôpital Bichat	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Pr Nathalie COSTEDOAT-CHALUMEAU

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome was the occurrence of cardiovascular events (CVE) over follow-up.	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	>20 months after PLUS inclusion
Secondary	Prevalence of CHIP in SLE		at PLUS inclusion