Detail Article

Informations générales (source: ClinicalTrials.gov)

Numéro NCT

NCT02561325 Statut inconnu

Titre

Comparative Evaluation of the Effect on Blood Pressure of an Equivalent Content of Sodium in the Form of Bicarbonate of Sodium and in the Form of Sodium Chloride, on "Sensitive Sodium" Subjects (SODIVASC)

Type

Interventional

Pathologie

Hypersensibilité

Phase

N/A

Promoteur

University Hospital, Clermont-Ferrand (Voir sur ClinicalTrials)

Date de début

septembre 2015

Date de fin

mars 2017

Dernière mise à jour

29 juin 2024

Résumé

Many large-scale epidemiological studies have established a link between the average consumption of table salt (sodium chloride) and blood pressure. In France a survey conducted in 2001 showed that the average consumption of salt is 9 to 10g per people / day, and health authorities considered it appropriate to reduce consumption about 20%, by limiting contributions of sodium in prepared foods, bread. In terms of basic and clinical research, the biological effects of sodium chloride dietary intake, have been the subject of numerous studies for several decades. This work showed that all subjects do not react uniformly to sodium chloride flows, determining what the investigators call people "sodium-sensitive". For these people the sodium intake elevated blood pressure, much more marked than in subjects called "sodium-resistant." "Sodium-sensitive" people represent 10 to 30% of the population. A marked over-representation of this phenotype was observed in patients with hypertension or a family history of hypertension. In addition, studies conducted in animals and humans indicate that sodium intake has a different impact on biological parameters mentioned above, as is done in the form of chloride salt or bicarbonate of sodium. Based on these factors, investigators developed a clinical trial protocol intended to highlight a possible differential effect in the biological effects of the same sodium intake (2.56 g / day) orally, depending on the nature salt.

Détail

Voir le détail Pre-selection: Clinical Pharmacology Center or Cardiology department Selection - Visit 1 : General practitioner's office or Clinical Pharmacology Center - Signature of informed consent form - Check of eligibility criteria - Clinical exam - Blood pressure measure - Blood sample (for renal biology) - Collection of concomitant treatments - Collection of food habits - Delivery of the dietary instructions and forbidden treatments Phenotyping period : (192 subjects) All the 192 subjects will realize the 3 first visits in order to determine if yes or no the subjects are "Sodium sensitive". Selection - Visit 1 : General practitioner's office or Clinical Pharmacology Center - Signature of informed consent form - Check of eligibility criteria - Clinical exam - Blood pressure measure - Blood sample (for renal biology) - Collection of concomitant treatments - Collection of food habits - Delivery of the dietary instructions and forbidden treatments Visit 2: General practitioner's office or Clinical Pharmacology Center - Collection of adverse events and concomitant treatment - Check of biological analysis - Clinical examination - Blood pressure measure - Attribution of treatment for 2 weeks - Delivery of a diary and of the blood pressure measure device Visit 3 : General practitioner's office or Clinical Pharmacology Center - Return of the diary, the blood pressure measure device and the treatment - Collection of adverse events and concomitant treatment - Extraction of the data of blood pressure - Delivery of the urinary bottle for the twenty-four-hour urine analysis before Visit 4 Determination of the subjects " sodium sensitive ". Sodium sensitive subjects will continue the study and non-sodium sensitive subjects will stop the study. Wash-out period n°1 (2 weeks at least) pursuit of the dietary instructions. Cross over study - Clinical Pharmacology Center :Center (48 subjects) All the subjects will realize the 4 visits of the cross over study, and will received Nacl and placebo according to the randomisation plan. Visit 4 and visit 6 contained the same interventions for the participant (exept the consultation with the dietetician) and visit 5 et 7 are the same regarding the interventions for the participant. First period Visit 4 - Day 0 : - Return of the urinary bottle - Collection of adverse events and concomitant treatment - Clinical examination - Blood pressure measure - Arterial compliance (non invasive) - Pregancy test (for women of childbearing age) - Measure of weight and height - Impedancemetry - Blood sample for biological analysis (electrolyte pattern + serum creatinine + Renine + Aldosterone + Angiotensin II and MPE assay) - Assay of urinary sodium excretion - Consultation with a dietician. - Delivery of a diet record , and a booklet to be completed every day of the study period - Reminder of the use of the blood pressure measure device - Delivery of the study treatment according to the randomisation plan : 6.51 g of NaCl per day to distribute on the various meals + 1.5 liters of spring water (poor in sodium) to drink each day, Or placebo NaCl every day to distribute on the various meals + 1.5 liters of spring water (with sodium bicarbonate) to drink each day. Every day during 14 days The first take of treatment will be done on the Clinical Pharmacology Center - Delivery of the urinary bottle for the twenty-four-hour urine analysis before Visit 5 Visit 5 (Day 14) : - Return of the urinary bottle, of the empty treatment (to check compliance), of the diet record and of the booklet - Collection of adverse events and concomitant treatment - Clinical examination - Blood pressure measure - Arterial compliance (non invasive) - Measure of weight - Impedancemetry - Blood sample for biological analysis (electrolyte pattern + serum creatinine + Renine + Aldosterone + Angiotensin II and MPE assay) - Assay of urinary sodium excretion - Delivery of the urinary bottle for the twenty-four-hour urine analysis before Visit 6 Wash-out 2 (at least 2 weeks) pursuit of the dietary instructions. Second study period Visit 6 (day28) - beginning period 2 Visite 7 (Day42) - end of period 2 and end of study This second period is the same as the first period, except that the subject will not have the consultation with the dietetician and will receive the other study treatment according to the randomization plan. Ancillary Study This trial contains an ancillary study of genotypage (optional with specific consent of the subject) with the aim of the confrontation with the phenotyping. For that purpose, a blood sample will be made in the period of selection on the subject who gives their consent, in the same time of the blood sample for renal biology at visit 1. These results would allow to identify biomarkers of blood pressure sensibility at the sodium. Fermer le détail

Etablissements

Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
CHU de Clermont-Ferrand - 63003 - Clermont-Ferrand - France	Patrick LACARIN	En recrutement		Contact (sur clinicalTrials)

Critères

Genre

Tous

Nombre d'inclusion

Critère d'inclusion

Inclusion Criteria:

-

- Systolic Blood pressure between 130-160 mmHg and/or diastolic 90-100, not
treated and/or family history of arterial high blood pressure (Father or
Mother),

- Between 18 and 75 years old

- Asymptomatic on the cardiovascular plan,

- Absence of known heart disorder,

- Brachial Perimeter between 22 and 42 cms,

- Creatinine clearance in the standards dating less than 12 months, (glomerular
filtration rate > 60 ml / mn / 1.73m²),

- Agreeing to drink some sparkling water during the periods of study,

- Effective method of birth control for women with childbearing potential

- Cooperation and understanding enough to conform to the study obligations

- Voluntary gives written informed consent to participate in the study

- Affiliated at system of French social security

- Inscription or acceptation of inscription in the national register of volunteers
involved in trials.

Critère de non inclusion

- -Treated by corticoids

- Treated by prohibited medications

- Pregnant or breastfeeding

- Treated by anti-hypertensive drug

- History of heart disease or ischemic heart disease

- Lack of sinus rhythm

- Renal insufficiency (glomerular filtration rate > 60 ml / mn / 1.73m ²)

- Uncontrolled hypertension (> 160 / 100mmHg)

- Incompatible comorbidity with the study

- BMI > 35 kg / m2

- Invalidating cognitive disorders

- Anxiety to use the device to measure blood pressure alone at home judged by the
investigator

- Diabetes (Type I and II)

- Chronic alcoholism

- Sports judged as intense (more than 3 hours per week of intense sports),

- Participation in another clinical trial, located in exclusion period or received
benefits > 4500 euros during 12 months before the beginning of trial,

- Cooperation and understanding that do not allow him to follow the trial,

- Patients with minor or under guardianship.

NCT02561325 - Comparative Evaluation of the Effect on Blood Pressure of an Equivalent Content of Sodium in the Form of Bicarbonate of Sodium and in the Form of Sodium Chloride, on "Sensitive Sodium" Subjects (SODIVASC)

Informations générales
Etablissements
Critères
Accès à la fiche NCT

Retour en haut