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Systemic Lupus ErythematosusHEMATOPLUSNCT05146414

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

An observational study of Systemic Lupus Erythematosus, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Any age
Conditions the study is for
Systemic Lupus Erythematosus
How many people
500 participants
Where
1 siteFrance
Study dates
10 Jul 2007to 10 Feb 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patient with a systemic lupus erythematosus

Who may be able to join

  • Patient with a systemic lupus erythematosus

Who cannot join

  • Inadequate follow-up period (< 20 months) -past history of CVE at baseline for inclusion in the TROPOPLUS study

Trial locations and contacts

1 site in 1 country.

France1 site

  • Hôpital Bichat

    Paris, 75018

Other trials in France

About this study

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

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.

Read the 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.

Keywords
Systemic lupus erythematosus, Clonal hematopoiesis of indeterminate potential, Cardiovascular events
Medical subject headings
Lupus Erythematosus, Systemic

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: >20 months after PLUS inclusion

Secondary outcomes (1)

  1. Prevalence of CHIP in SLE

    Measured: at PLUS inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Dec 2021
  2. Study start10 Jul 2007
  3. Primary completion23 Jan 2018
  4. Study completion10 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
500 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05146414
Sponsor's protocol ID
CRC18058
Acronym
HEMATOPLUS
Status last verified
Oct 2021
First submitted
25 Nov 2021
Last updated
6 Dec 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 35176141

Questions about this trial

What is this clinical trial studying?

An observational study of Systemic Lupus Erythematosus, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary outcome was the occurrence of cardiovascular events (CVE) over follow-up. (time frame: >20 months after PLUS inclusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05146414, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2021.

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