NCT06960902

Brief Summary

The goal of this study (interventional clinical research not involving a health product) is to assess the prevalence of subclinical coronary atherosclerosis diagnosed by coronary CT angiography in heart failure patients in primary prevention, across different levels of cardiovascular risk defined by coronary artery calcium (CAC) score percentiles (based on data from the MESA study): low risk (≤25th percentile for age, sex, and ethnicity), intermediate risk (25th \< CAC ≤ 75th percentile), and high risk (\>75th percentile). The Patients will attend an on-site visit at inclusion (and must undergo a coronary CT angiography within 6 months following this visit), will be contacted by phone at 1 year and 2 years, and will return for an on-site visit at 30 months.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
41mo left

Started Sep 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

9 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress15%
Sep 2025Sep 2029

First Submitted

Initial submission to the registry

April 29, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 7, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

September 25, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2027

Expected
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2029

Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

1.5 years

First QC Date

April 29, 2025

Last Update Submit

March 16, 2026

Conditions

Atherosclerotic Cardiovascular Disease (ASCVD)Familial Hypercholesterolemias

Keywords

Familial hypercholesterolemiaatherosclerotic cardiovascular disease

Outcome Measures

Primary Outcomes (1)

  • Presence of subclinical coronary atherosclerosis

    The criterion defining the presence of subclinical coronary atherosclerosis is the presence of at least one coronary stenosis greater than 50% in a main artery on coronary CT angiography

    At the time of performing the coronary CT scan

Secondary Outcomes (31)

  • Identification of factors associated with the presence or absence of subclinical coronary atherosclerosis (coronary stenosis > 50% on coronary CT scan).

    30 months

  • Identification of factors associated with the presence or absence of subclinical coronary atherosclerosis (coronary stenosis > 50% on coronary CT scan).

    30 months

  • Identification of factors associated with the presence or absence of subclinical coronary atherosclerosis (coronary stenosis > 50% on coronary CT scan).

    30 months

  • Identification of factors associated with the presence or absence of subclinical coronary atherosclerosis (coronary stenosis > 50% on coronary CT scan).

    30 months

  • Identification of factors associated with the presence or absence of subclinical coronary atherosclerosis (coronary stenosis > 50% on coronary CT scan).

    30 months

  • +26 more secondary outcomes

Study Arms (1)

Single arm

OTHER

Visit 1: Inclusion Visit: Verification of eligibility criteria. Consent form signing, collection of clinical information, and completion of questionnaires. Fasting blood draw for biological analyses and biobanking. Collection of urine and stool samples (optional). POpmeter (optional), Fibroscan (optional), completion of the CONSTANCES and SF36 questionnaires. Visit 2 (30 months): Collection of the CAC score result (dated less than 6 months prior). Collection of clinical information and completion of questionnaires. Fasting blood draw for biological analyses and biobanking. Collection of urine and stool samples (optional). pOpmeter (optional), Fibroscan (optional), completion of the CONSTANCES and SF36 questionnaires. Major cardiovascular events will be collected from patients during telephone calls at 1 and 2 years, and during the 30-month visit.

Other: Coronary CT scan with CAC score measurement

Interventions

Coronary CT scan with CAC score measurementOTHER

Coronary CT scan with CAC score measurement (on the same day or within 6 months after the inclusion visit).

Single arm

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Person willing to sign the study consent form
  • Person affiliated with a current social security scheme
  • Person with a definite diagnosis of Familial Hypercholesterolemia, defined by a Dutch Lipid Clinic Network (DLCN) clinical-biological score \> 8 and/or an identified causal mutation in the LDL receptor (LDLR) gene, apolipoprotein B100 gene, PCSK9 gene, or apolipoprotein E gene
  • Male aged 40 years or older, or female aged 50 years or older
  • Ability to understand French for questionnaire completion
  • Person not taking any antihypertensive medication or on a stable dose of antihypertensive therapy for at least one month at Visit 1
  • Person not taking any antidiabetic medication or on a stable dose of antidiabetic therapy for at least 3 months at Visit 1

You may not qualify if:

  • Subject with a technical contraindication for coronary CT scan: patient diameter \> 70 cm and/or weight \> 250 kg
  • Patient with a history of atherosclerotic cardiovascular event (myocardial infarction, ischemic heart disease, coronary revascularization, ischemic stroke, carotid endarterectomy, lower limb arterial revascularization)
  • Patient allergic to iodinated contrast agents
  • Severe renal insufficiency: estimated glomerular filtration rate (eGFR) according to the CKD-EPI formula ≤ 30 ml/min
  • Subject with active cancer or in remission for less than 3 years
  • Subject who has received oral or intravenous corticosteroid therapy within the last 6 months
  • Subject with untreated or poorly controlled hypothyroidism
  • Subject receiving immunosuppressive or anticancer therapy
  • Subject refusing to participate
  • Subject under guardianship, curatorship, or judicial protection, or without social insurance coverage
  • Pregnant woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

CHU Dijon Bourgogne

Dijon, France

RECRUITING

CHRU Lille

Lille, France

NOT YET RECRUITING

Hospices Civils de Lyon

Lyon, France

RECRUITING

Hôpital de la Conception, AP-HM

Marseille, France

NOT YET RECRUITING

CHU Nantes

Nantes, France

RECRUITING

Hôpital de la Pitié-Salpêtrière, AP-HP

Paris, France

RECRUITING

Hôpital Saint-Antoine, AP-HP

Paris, France

RECRUITING

CHU Rennes

Rennes, France

RECRUITING

CHU Strasbourg

Strasbourg, France

RECRUITING

MeSH Terms

Conditions

Hyperlipoproteinemia Type IIAtherosclerosis

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHyperlipoproteinemiasHyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Bertrand CARIOU, Pr

CONTACT

+33 2 53 48 27 10bertrand.cariou@chu-nantes.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Pathophysiology study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2025

First Posted

May 7, 2025

Study Start

September 25, 2025

Primary Completion (Estimated)

March 25, 2027

Study Completion (Estimated)

September 25, 2029

Last Updated

March 19, 2026

Record last verified: 2026-03

Locations

FR(9)