Clinical trial NCT05146414: Clonal Hematopoiesis of Indeterminate Potential and Accelerated Atherosclerosis in Systemic Lupus Erythematosus
Official title: Clonal Hematopoiesis of Indeterminate Potential and Accelerated Atherosclerosis in Patients With Systemic Lupus Erythematosus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Systemic Lupus Erythematosus
Keywords: Systemic lupus erythematosus
Clonal hematopoiesis of indeterminate potential
Cardiovascular events
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Pr Nathalie COSTEDOAT-CHALUMEAU
First posted: 2021-12-06
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient with a systemic lupus erythematosus

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.

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

Primary outcomes:
measure: The primary outcome was the occurrence of cardiovascular events (CVE) over follow-up.
timeFrame: >20 months after PLUS inclusion
Secondary outcomes:
measure: Prevalence of CHIP in SLE
timeFrame: at PLUS inclusion
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Bichat
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Karim SACRE, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: David C, Duployez N, Eloy P, Belhadi D, Chezel J, Guern VL, Laouenan C, Fenwarth L, Rouzaud D, Mathian A, de Almeida Chaves S, Duhaut P, Fain O, Galicier L, Ghillani-Dalbin P, Kahn JE, Morel N, Perard L, Pha M, Sarrot-Reynauld F, Aumaitre O, Chasset F, Limal N, Desmurs-Clavel H, Ackermann F, Amoura Z, Papo T, Preudhomme C, Costedoat-Chalumeau N, Sacre K. Clonal haematopoiesis of indeterminate potential and cardiovascular events in systemic lupus erythematosus (HEMATOPLUS study). Rheumatology (Oxford). 2022 Nov 2;61(11):4355-4363. doi: 10.1093/rheumatology/keac108.