NCT05146414|Completed
Clonal Hematopoiesis of Indeterminate Potential and Accelerated Atherosclerosis in Systemic Lupus Erythematosus
HEMATOPLUS
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HEMATOPLUS
Sponsor study identifier
observational
500
1 country
1
Study Start
July 10, 2007
Actual (reported)Primary Completion
January 23, 2018
Actual (reported)Study Completion
February 10, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 10, 2021
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 10, 2007
Actual (reported)January 23, 2018
Actual (reported)February 10, 2021
Actual (reported)November 25, 2021
Actual (reported)December 6, 2021
Actual (reported)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
Prevalence of CHIP in SLE
at PLUS inclusion
Patient with a systemic lupus erythematosus
Contact the study team to confirm eligibility.
Hôpital Bichat
Paris, 75018, France
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.
Karim SACRE, MD,PhD
Assistance Publique - Hôpitaux de Paris
500 participants (actual enrollment reported by the registry).
First Submitted
November 25, 2021
First Posted
December 6, 2021
Study Start
July 10, 2007
Actual (reported)Personalised Pharmacological Approach to the Tapering of Corticosteroid Doses in Systemic Lupus Patients Treated With Prednisone
Primary Completion
January 23, 2018
Actual (reported)Study Completion
February 10, 2021
Actual (reported)Last Updated
December 6, 2021
Record last verified: 2021-10
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Source: ClinicalTrials.gov.
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