FAMILY INHERITANCE, GENE-GENE AND GENE-ENVIRONMENT INTERACTIONS IN THE FIELD OF CARDIOVASCULAR AND RENAL DISEASES. Fifth Visit of the STANISLAS Cohort

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorCentral Hospital, Nancy, France

About this trial

The Stanislas Cohort is a monocentric familial longitudinal cohort originally comprised of 1006 families consisting of two parents and at least two biological children and deemed healthy, recruited in 1993-1995 at the Centre for Preventive Medicine of Nancy. This cohort was established with the primary objective of investigating gene-gene and gene-environment interactions in the field of cardiovascular diseases. The 5th visit of the STANISLAS Cohort will allow a better evaluation of the cardiovascular ageing of the population and the transition toward cardiovascular or renal diseases in relation with their genetic profile and environment.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

aged over 18

Person who participated in the Stanislas Cohort

Person affiliated to a social security scheme or beneficiary of such a scheme

Person having received complete information on the organization of the research and having signed an informed consent

Disqualifiers

Persons deprived of their liberty by a judicial or administrative decision, persons undergoing psychiatric treatment under Articles L. 3212-1 and L. 3213-1

Pregnant woman, parturient or nursing mother

Adult person subject to a legal protection measure (guardianship, curatorship, safeguard of justice)

Person of full age unable to express consent

Trial design

Design model

Single group

Treatments tested in this trial

  • Blood and urine samples

    Biological/Vaccine

    Blood and urine samples

  • Blood samples

    Genetic

    Blood samples

  • Cardiovascular assessment

    Other intervention

    Echocardiography, Lung ultrasound, pulse wave velocity, carotid stiffness and thickness, Central and peripheral blood pressure, carotid pulse pressure, abdominal aorta ultrasound, jugular vein ultrasound, liver elastography (Optional).

  • Dietary intake

    Behavioral

    Food frequency questionnaires, ''Dutch eating behaviour questionnaire'' and dietary supplement questionnaire

  • Anthropometric parameters

    Other intervention

    Measurement of height, weight, abdominal circumference, hip circumference, arm circumference

  • Hemodynamic parameters

    Other intervention

    Systolic pressure index measurement

  • Hemodynamic parameters

    Other intervention

    Heart rate measurements, blood pressure measurements, orthostatic BP measurements

  • Hemodynamic parameters

    Other intervention

    Blood pressure measurements by "unattended BP" monitor over 5 min

  • Hemodynamic parameters

    Other intervention

    Electrocardiogram

  • Assessment of compliance with antihypertensive treatments for treated participants

    Behavioral

    EVALOBS scale and compliance questionnaire

  • Ambulatory 24 hours measurment of blood pressure

    Other intervention

    For the first 100 patients willing to participate

  • 24 hours urinary collection

    Biological/Vaccine

    For the first 100 patients willing to participate. For biobank constitution and measurement of microalbuminuria, creatininuria, osmolarity, natriuresis, kaliuresis, urea, proteinuria and urine dipstick

  • General questionnaires

    Other intervention

    Collection of socio-demographic data such as age, level of education, profession, household income, smoking status, physical activity, perception of health, prematurity, height and weight at birth, family and personal history especially cardiovascular (history of stroke, myocardial infarction, heart failure, current pathologies, drugs, tobacco...)

  • Women specific questionnaire

    Other intervention

    Women specific questionnaire

  • Women specific questionnaire

    Behavioral

    Women specific questionnaire

  • NYHA dyspnea questionnaire

    Diagnostic test

    Determination of NYHA class.

  • Anxiety questionnaire

    Behavioral

    Assessment of anxiety

  • Epworth Sleepiness Scale

    Behavioral

    sleep quality assessment

  • A questionnaire on the "perception of the management of cardiovascular risk factors"

    Other intervention

    Patient's evaluation of cardiovascular risk factors by the health system

  • A questionnaire on eating behaviors

    Behavioral

    Assessment of eating behaviors

  • A questionnaire on eating habits to determine consumer profiles

    Behavioral

    Assessement of eating habit to create a consumer profile

  • A questionnaire on food supplements use

    Dietary supplement

    Evaluation od food supplements intake

  • SARS-CoV-2 Infection Questionnaire

    Other intervention

    SARS-CoV-2 Infection Questionnaire

  • Instantaneous expired air analysis

    Other intervention

    Carbon monoxyde analysis in expired air

  • Capillary sampling

    Biological/Vaccine

    Capillary sampling for pollutant analysis (Optional)

Treatment groups

3,000 Participants
are divided into 1 treatment group
Group A: Healthy volonteerExperimental treatment 22 interventions

Trial outcomes

Primary outcomes

1

Indexed left ventricular mass measured by echocardiography

Time frame
Baseline
2

Left ventricular volume measured by echocardiography

Time frame
Baseline
3

Tissue doppler imaging e' wave measured by echocardiography

Time frame
Baseline
4

Ratio E/e' measured by echocardiography

Time frame
Baseline

Secondary outcomes

1

Estimation of the glomerular filtration rate (CKD-EPI formula)

Composite endpoint of degradation of renal function (With outcome 11)

Time frame
Baseline
2

Proteinuria (on sample)

Composite endpoint of degradation of renal function (With outcome 10)

Time frame
Baseline
3

Blood glucose

Composite endpoint of degradation of metabolic parameters (With outcome 13 and 14)

Time frame
Baseline
4

Change in HbA1C

Composite endpoint of degradation of metabolic parameters (With outcome 12 and 14)

Time frame
Baseline

Other outcomes

Sponsors and contacts

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