NCT07330804

Brief Summary

Cardiovascular disease (CVD) mortality is the leading cause of death in high-income countries (particularly the United States), accounting for 23.1% of all deaths It has been established over several decades that hypertension disproportionately affects African Americans, compared with Americans of European descent:Hypertension occurs more often, at an earlier age , with greater severity , and is associated with an approximately 3-fold higher probability of death .There is also poorer control of hypertension despit e similar treatment In African Americans, CVD morbidity and mortality are compounded by the higher prevalence of T2DM, obesity, CKD, stroke, and heart failure . Despite advances in the identification of risk factors and the availability of effective treatment in hypertension, CVD disparities, persist among African Americans and are expected to increase in the future, particularly in younger age groups. Although various environmental and social factors certainly contribute to these disparities, a genetic basis, involving numerous "candidate" genes, is most often asserted in the literature . One of these is the Corin gene (Pan et al, 2002) which codes for the Corin protein.The latter plays a pivotal role in cardiometabolic pathophysiology through its role in the activation of natriuretic peptides .Natriuretic peptides (ANP and BNP) have a major role in the regulation of blood pressure through their vasodilatory and diuretic action. They have a lusotropic action, inhibit the renin angiotensin system, and are involved in energy metabolism (increased lipolysis and insulin secretion). They also have an anti-fibrotic, anti-proliferative, anti-inflammatory and anti-thrombotic action.The Corin gene of 244109pb has many variants that produce an inefficient protein with the corollary of the appearance of metabolic and cardiovascular pathologies in the first rank of which the HTA, the cardiac insufficiency and the renal insufficiency .Recently, a double polymorphism of the Corin gene consisting of 2 SNPs (single nucleotide polymorphisms) on the same allele of the Corin gene (I555/P568) has been reported. This allele is present in the heterozygous state in 12% of African Americans but is extremely rare in Americans of European descent (\<0.5%).This double polymorphism (I555/P568) has been shown to be responsible for an approximately 70% reduction in the ability of the mutated Corin protein to convert proANP or proBNP to the active form. In addition, the I555(P568) allele of Corin protein is associated with an increased risk of hypertension and concentric cardiac hypertrophy The corin allele (I555/P568) is reported to be associated with poorer response to validated heart failure therapy and a higher risk of death or hospitalization for heart failure . In Guadeloupe, where the population is predominantly of African descent.Cardiovascular disease is the leading cause of mortality.The prevalence of hypertension is 39% and more than 50% after 50 years of age . It has increased by 10% in 10 years in Guadeloupe. In France, where the prevalence of hypertension is 31%, it has increased by only 5% over the same period. Heart failure is the main cause of admission to the cardiological emergency room of the University Hospital (49%) with a mortality of 37% at 6 months. Hypertension is the first risk factor associated with heart failure (80%).To date, there are no studies on corin gene polymorphisms in Guadeloupe. Following the example of work already done in the African American population, we propose to study the role of the double polymorphism (I555/P568) in the determinism of hypertension in the population of African descent in Guadeloupe.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
370

participants targeted

Target at P75+ for not_applicable

Timeline
3mo left

Started Jan 2025

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress85%
Jan 2025Aug 2026

Study Start

First participant enrolled

January 16, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2025

Completed
9 months until next milestone

First Posted

Study publicly available on registry

January 9, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

January 9, 2026

Status Verified

January 1, 2025

Enrollment Period

1.5 years

First QC Date

April 28, 2025

Last Update Submit

January 5, 2026

Conditions

Keywords

double polymorphismeCorinnatriuretic peptidebiomarkerAfro Caribbean

Outcome Measures

Primary Outcomes (1)

  • double polymorphism

    1. Genotyping by capillary electrophoresis (Sanger sequencing): 2. Genotyping using the allelic discrimination method

    At day 15

Secondary Outcomes (18)

  • heart failure

    At inclusion

  • Renal failure

    At Day 15

  • natriuretic peptid (NT PRO BNP)

    At Day 15

  • créatinine clearance

    At Day 15

  • Fasting blood glucose

    At Day 15

  • +13 more secondary outcomes

Study Arms (2)

cases

OTHER

Patients, considering themselves to be of Afro-Caribbean origin with hypertension, treated for hypertension or diagnosed as carrying hypertension according to HAS recommendations (Prise en charge de l'Hypertension artérielle de l'adulte, sept 2016): "elevation of blood pressure (BP), including systolic blood pressure (SBP) ≥140 mmHg and/or diastolic blood pressure (DBP) ≥ 90 mmHg" measured in the doctor's office and confirmed over several consultations on the day of inclusion. The diagnosis of hypertension can also be made by self-measurement over 3 days (mean PAS \>135 mmHg and/or PAS\> 85 mmHg) or by ABPM (Ambulatory Blood Pressure Monitoring: Holter Tensionnel) with PAS \>135 mmHg and/or PAD \>85 mmHg for the daytime period (awake); PAS\>120 mmHg and/or PAD\> 70 mmHg for the nighttime period (asleep). In the case of hypertension, mean PAS \> 130 mmHg and PAD \> 80 mmHg. ESC/ESH 2018 recommendations

Diagnostic Test: double polymorphism

Controls

OTHER

Patients who consider themselves to be of Afro-Caribbean origin, of the same sex and ± 5 years of age as the cases, with no diagnosis of hypertension. Controls will be recruited by the same physicians who included a person with hypertension, but consulting for any other symptoms.

Diagnostic Test: double polymorphism

Interventions

double polymorphismDIAGNOSTIC_TEST

diagnostic test

Also known as: cases
Controlscases

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Persons affiliated with or benefiting from a social security plan;
  • Over 18 years of age;
  • Considering themselves to be of Afro-Caribbean descent;
  • Individuals affiliated with or benefiting from a social security plan;
  • Over 18 years of age;

You may not qualify if:

  • Minors; Pregnant or breastfeeding women; Protected persons, or persons under court protection; Refusal to participate. Patients unable to come to the laboratory

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Medical practice KERIB

Petit-Bourg, 97170, Guadeloupe

RECRUITING

Toncoeurtonka

Petit-Canal, 97131, Guadeloupe

NOT YET RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2025

First Posted

January 9, 2026

Study Start

January 16, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

January 9, 2026

Record last verified: 2025-01

Locations