Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-25 @ 4:03 AM
NCT ID:
NCT05108402
Eligibility Criteria:
Inclusion Criteria:
* Systolic blood pressure between 135-160 mmHg and diastolic 85-100 in self-measurement, untreated or treated but not balanced under treatment,
* Father or mother hypertensive,
* Weight ≥ 50 kg
* Absence of known heart disease,
* Brachialis perimeter between 22 and 42 cm,
* Creatinine clearance within the standards dating from less than 12 months, (GFR\> 60ml / min / 1.73m²),
* Agreeing to drink sparkling water during one of the study periods,
* Effective contraception for female subjects of childbearing age,
* Cooperation and understanding sufficient to comply with the requirements of the test,
* Affiliated with a Social Security scheme,
* Agreeing to give written consent,
* Registration or acceptance of registration in the national register of volunteers participating in research.
Exclusion Criteria:
* Consumption of more than 5g/day of salt in the protocol diet (evaluated by natriuresis analyzed in V3)
* Systemic corticosteroid therapy
* Taking prohibited drugs (see list) and at the judgment of the investigator.
* Suffering from pulmonary hypertension
* Woman of childbearing age not using an effective contraceptive method, pregnant or breastfeeding woman,
* History of cardiomyopathy or ischemic heart disease,
* Absence of sinus rhythm,
* Renal failure (DFG \<60 ml/min/1.73m²),
* Comorbidity incompatible with the study,
* BMI\> 35 kg/m2,
* Disabling cognitive disorders,
* Anxiety when taking measurements alone at home at the judgment of the investigator,
* Diabetes (Type I and II)
* Chronic alcoholism,
* Sports activity deemed to be intense (more than 3 hours / week of intense sport),
* Extreme sweating activity (Sauna, Hammam),
* During participation in another clinical trial, or in the exclusion period, or having received a total amount of compensation greater than 4,500 euros over the 12 months preceding the start of the trial,
* Benefiting from a legal protection measure (curatorship, guardianship, deprived of freedoms, safeguard of justice)
* Not affiliated with the French Social Security scheme.
* Any history deemed significant by the investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05108402
Study Brief:
Protocol Section:
NCT05108402