HypertensionSODIVASC-IINCT05108402
Comparison on Blood Pressure Effect of an Equivalent Sodium Intake, With Different Nature, for Hypertensive Subjects
A study testing Phenotyping and Drug intake in people with Hypertension, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Numerous large-scale epidemiological studies have made it possible to establish a link between the average consumption of table salt (sodium chloride) and blood pressure figures. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Phenotyping and Drug intake
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2022to Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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),
Show all 12Show fewer
- 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.
Who cannot join
- 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,
Show all 20Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site
Platform of Clinical Investigation / Clinical Investigation Center French Institute of Health and Medical Research-1405 University Hospital
Clermont-Ferrand, Auvergne, 63000
Louis LE GUEN, 04 73 75 17 84 13, lleguen1@chu-clermontferrand.fr
Marion COURRENT, 04 73 75 17 84 24, mcourrent@chu-clermontferrand.fr
About this study
Official title: Comparative Evaluation on Blood Pressure Effect of an Equivalent Sodium Intake, in the Form of Bicarbonate or Chloride, for Hypertensive Subjects.
Numerous large-scale epidemiological studies have made it possible to establish a link between the average consumption of table salt (sodium chloride) and blood pressure figures. In France, according to the French Agency for Food, Environmental and Occupational Health \& Safety (ANSES), salt intakes could be estimated from 2 national food consumption surveys INCA 1 and INCA 2. This made it possible to take a photograph of food consumption habits and to show that the average consumption of salt contained in food in France is 8.7g/day for men and 6.7g/day for women. To these contributions must also be added 1 to 2g of salt for the resalting and the cooking water. According to the food consumption survey INCA 3, french plate still contains a large part of processed foods and still a little too much salt (on average 9g/day for men and 7g/day for women at compare with the objectives of the National Health Nutrition Program of 8g/day and 6.5g/day respectively). In addition, the World Health Organization (WHO) recommends consuming less than 5g of salt per day.
In this context, sodium intake through mineral water was also questioned. Both in terms of basic and clinical research, the biological effects of dietary sodium chloride intake have been the subject of a great deal of work for several decades. The mechanisms of transmission in the induced or hemodynamic effects related to the absorption of Na multiple debates and their impact on cardiovascular risks remain very uncertain. Work has shown that all subjects do not react homogeneously to sodium chloride intakes, thus determining what are called "NaCl-sensitive" people who in a situation of major sodium intake will show an increase of peripheral vascular resistance and an increase in blood pressure, much more marked than in subjects called " NaCl resistant ".
Read more
"NaCl-sensitive" people represent 10 to 30% of the population, with notable differences according to ethnic origins, regions and continents. A marked overrepresentation of this phenotype is observed in patients with hypertension or with a family history of hypertension.
Furthermore, studies conducted on animals and humans show that sodium intake does not have the same impact on the parameters mentioned above, depending on whether it is in the form of chloride or bicarbonate salt.
On the basis of these elements, the investigators developed a clinical study protocol intended to demonstrate a possible differential effect in the biological effects of the same sodium orally intake (2.56g per day), depending on the salt origin.
Read the detailed description
This single-center, randomized study, aim to determine the difference in absorption between sodium depending on its nature: bicarbonate (NaHCO3) or chloride (NaCl), and the effect of those types of sodium on blood pressure.
In order to realize it, 206 volunteers will be include to assess whether or not they are a "NaCl sensitive volunteer" phenotype.
The study will be carried out on 34 of NaCl sensitive volunteer which will take the sodium dietary supplements. The 2 dietary supplements are table salt (sachet) or bottled water. They will be test in a cross-over design during 2 periods of 1 week separated from 1 week of a washing-out period.
The primary objective will be to compare mean arterial pressure (MAP) resulting from daily supplementation of 2.56 g of sodium (111 mmol), in addition to the food intake of a low-sodium diet from V2 to the end of the study (<5g of NaCl / day), for 7 days, either as sodium chloride or as sodium bicarbonate in hypertensive subjects.
This clinical trial will be separated in 2 phases:
- Phenotyping (4 visits): to determine if the volunteer is "NaCl sensitive volunteer" or not
- V1 (day -28/D-28) = inclusion and beginning of phenotyping phase,
- V2 (day -21/D-21) = start of a low-sodium diet (<5g of NaCl / day),
- V3 (day -14/D-14) = daily supplementation of sodium chloride for 7 days (9.78g/day),
- V4 (day -7/D-7) = "NaCl sensitive volunteer" assessment, end of study for "NaCl non-senstive volunteers".
- Treatment period for "NaCl sensitive volunteer" with dietary supplement intake in a cross-over design:
- PC1 (day 0/D0) = beginning of treatment period 1,
- PC2 (day 3/D3) = volunteer contact to make sure he is all right,
- V5 (day 7/D7) = end treatment period 1,
- PC3 (day 14/D14) = beginning of treatment period 2,
- PC4 (day 17/D17) = volunteer contact to make sure he is all right,
- V6 (day 21/D21) = end of treatment period 2 and of the study.
The protocol includes a total of 6 visits to PIC/CIC Inserm 1405 of the Clermont-Ferrand University Hospital.
The maximum duration of the study will be of 7 weeks.
- Conditions
- Hypertension
- Being tested
- Phenotyping, Drug intake
- Keywords
- Sodium intake, Blood pressure, high blood pressure, bicarbonate sodium, chloride sodium, NaCl sensitive
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhenotypingDiagnostic test
After inclusion in the study, between V1 and V4, patients will be phenotyped among: "NaCl sensitive" patients and "non-NaCl sensitive" patients. they will have a low sodium diet for 2 weeks. The first week without salt supplementation and the second with salt supplementation. At the end of V4, if patient is "NaCl sensitive" he will continue into treatment period and go through randomization, and for patient "non-NaCl sensitive" they will drop out of study.
Drug intakeDietary supplement
After being phenotyped, "NaCl sensitive" patients will continue the study in one of the 2 treatments arms : royal water (bottle) or salt sachet.
| Study group | Role | What they receive |
|---|---|---|
| Bottle of water | Experimental | After inclusion in the study, the patients are phenotyped between V1 and V4. Following this, they will be separated into 2 groups: "NaCl sensitive" patients and "non-NaCl sensitive" patients. The non-sensitive group will drop out of the study, while the others will be randomized to one of the 2 treatment arms: bottle of water or sachet of salt. Receives: Diagnostic Test: Phenotyping; Dietary Supplement: Drug intake |
| Salt sachet | Active comparator | After inclusion in the study, the patients are phenotyped between V1 and V4. Following this, they will be separated into 2 groups: "NaCl sensitive" patients and "non-NaCl sensitive" patients. The non-sensitive group will drop out of the study, while the others will be randomized to one of the 2 treatment arms: bottle of water or sachet of salt. Receives: Diagnostic Test: Phenotyping; Dietary Supplement: Drug intake |
| No treatment | Other | After inclusion in the study, the patients are phenotyped between V1 and V4. Following this, they will be separated into 2 groups: "NaCl sensitive" patients and "non-NaCl sensitive" patients. The non-sensitive group will drop out of the study, while the others will be randomized to one of the 2 treatment arms: bottle of water or sachet of salt. Receives: Diagnostic Test: Phenotyping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from mean blood pressure (MBP) at Day 21
Comparison between blood pressure data recorded by the volunteer between the 2 weeks of treatment (measurement during 2 days before Day 7 and 2 days before Day 21).
Recording of systolic and diastolic blood pressure will be made by the patient at home with the Microlife BP A200 device, in the morning and evening.
Comparison of the data collected from these 2 weeks of treatment will allow us to meet the main objective of the study.
Measured: Day 21
Secondary outcomes (17)
Change from mean blood pressure (MBP) at Day -7
Comparison between blood pressure data recorded by the volunteer for the last 2 days before Day -14 and the last 2 days before Day -7.
Recording of systolic and diastolic blood pressure will be made by the patient at home with the Microlife BP A200 device, in the morning and evening to determine if the subject is "NaCl sensitive" or not.
Measured: Day -7
Weight
Measure of patient weight (in kilograms) using a weighing machine.
Measured: Day -28, Day -21, Day -14, Day -7, Day 7 and Day 21
Body composition analysis
Measurement of water quantities in the body, fat and muscle, will be analyzed using an non-invasive device by impedance measurement. Patient will be comfortably installed in a quiet room, lying down on a bed where two electrodes will be applied, one at the level of the hand, the other at the level of the foot.
Measured: Day -21, Day -14, Day -7, Day 7 and Day 21
Optional genotyping
With patient agreement: 1 tube of blood (9mL) used for genetics analysis: genotyping
Measured: One time at Day -28
Plasma renin dosage on fasted state
Concentration of renin in plasma (ng/mL/h) will be measured on fasted state.
Measured: Day -28, Day -14, Day -7, Day 7 and Day 21
Plasma Angiotensin II dosage on fasted state
Concentration of angiotensin II (µg/L) in plasma will be measured on fasted state.
Measured: Day -28, Day -14, Day -7, Day 7 and Day 21
Plasma Aldosterone dosage on fasted state
Concentration of aldosterone (pg/mL) in plasma will be measured on fasted state.
Measured: Day -28, Day -14, Day -7, Day 7 and Day 21
Plasma potassium dosage on fasted state
Concentration of potassium (mmol/L) in plasma will be measured on fasted state.
Measured: Day -28, Day -14, Day -7, Day 7 and Day 21
Plasma sodium dosage on fasted state
Concentration of sodium (mmol/L) in plasma will be measured on fasted state.
Measured: Day -28, Day -14, Day -7, Day 7 and Day 21
Plasma calcium dosage on fasted state
Concentration of calcium (mmol/L) in plasma will be measured on fasted state.
Measured: Day -28, Day -14, Day -7, Day 7 and Day 21
Plasma chlorine dosage on fasted state
Concentration of chlorine (mmol/L) in plasma will be measured on fasted state.
Measured: Day -28, Day -14, Day -7, Day 7 and Day 21
Plasma protein dosage on fasted state
Concentration of protein (mmol/L) in plasma will be measured on fasted state.
Measured: Day -28, Day -14, Day -7, Day 7 and Day 21
Serum creatinine dosage on fasted state
Concentration of creatinine (mmol/L) in serum will be measured on fasted state.
Measured: Day -28, Day -14, Day -7, Day 7 and Day 21
Serum urea dosage on fasted state
Concentration of urea (mmol/L) in serum will be measured on fasted state.
Measured: Day -28, Day -14, Day -7, Day 7 and Day 21
Sodium concentration in 24h urine
Concentration of sodium in urine (mmol/24h) will be measured.
Measured: Day -28, Day -14, Day -7, Day 7 and Day 21
Potassium concentration in 24h urine
Concentration of potassium in urine (mmol/24h) will be measured.
Measured: Day -28, Day -14, Day -7, Day 7 and Day 21
Creatinine concentration in 24h urine
Concentration of creatinine in urine (mmol/24h) will be measured.
Measured: Day -28, Day -14, Day -7, Day 7 and Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2021
- Study startJan 2022 (estimated)
- Primary completionJan 2023 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Single-center, randomized study, organized in 2 stages.
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gisele PICKERING, MD, Principal investigator, Platform of Clinical Investigation/Clinical Investigation Center French Institute of Health and Medical Research-1405 63000 Clermont-Ferrand FRANCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05108402
- Sponsor's protocol ID
- RBHP 2021 PICKERING 3
- Other IDs
- 2021-A01134-37
- Acronym
- SODIVASC-II
- Status last verified
- Sep 2021
- First submitted
- 9 Sep 2021
- Last updated
- 4 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation on Blood Pressure Effect of an Equivalent Sodium Intake, in the Form of Bicarbonate or Chloride, for Hypertensive Subjects.
- ClinicalTrials.gov ID
- NCT05108402
- Acronym / sponsor ID
- SODIVASC-II / RBHP 2021 PICKERING 3
- Conditions
- Hypertension
- Keywords
- Sodium intake, Blood pressure, high blood pressure, bicarbonate sodium, chloride sodium, NaCl sensitive
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Jan 2022 (estimated)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 4 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Numerous large-scale epidemiological studies have made it possible to establish a link between the average consumption of table salt (sodium chloride) and blood pressure figures. In France, according to the French Agency for Food, Environmental and Occupational Health \& Safety (ANSES), salt intakes could be estimated from 2 national food consumption surveys INCA 1 and INCA 2. This made it possible to take a photograph of food consumption habits and to show that the average consumption of salt contained in food in France is 8.7g/day for men and 6.7g/day for women. To these contributions must also be added 1 to 2g of salt for the resalting and the cooking water. According to the food consumption survey INCA 3, french plate still contains a large part of processed foods and still a little too much salt (on average 9g/day for men and 7g/day for women at compare with the objectives of the National Health Nutrition Program of 8g/day and 6.5g/day respectively). In addition, the World Health Organization (WHO) recommends consuming less than 5g of salt per day.
In this context, sodium intake through mineral water was also questioned. Both in terms of basic and clinical research, the biological effects of dietary sodium chloride intake have been the subject of a great deal of work for several decades. The mechanisms of transmission in the induced or hemodynamic effects related to the absorption of Na multiple debates and their impact on cardiovascular risks remain very uncertain. Work has shown that all subjects do not react homogeneously to sodium chloride intakes, thus determining what are called "NaCl-sensitive" people who in a situation of major sodium intake will show an increase of peripheral vascular resistance and an increase in blood pressure, much more marked than in subjects called " NaCl resistant ".
"NaCl-sensitive" people represent 10 to 30% of the population, with notable differences according to ethnic origins, regions and continents. A marked overrepresentation of this phenotype is observed in patients with hypertension or with a family history of hypertension.
Furthermore, studies conducted on animals and humans show that sodium intake does not have the same impact on the parameters mentioned above, depending on whether it is in the form of chloride or bicarbonate salt.
On the basis of these elements, the investigators developed a clinical study protocol intended to demonstrate a possible differential effect in the biological effects of the same sodium orally intake (2.56g per day), depending on the salt origin.
Detailed description
This single-center, randomized study, aim to determine the difference in absorption between sodium depending on its nature: bicarbonate (NaHCO3) or chloride (NaCl), and the effect of those types of sodium on blood pressure.
In order to realize it, 206 volunteers will be include to assess whether or not they are a "NaCl sensitive volunteer" phenotype.
The study will be carried out on 34 of NaCl sensitive volunteer which will take the sodium dietary supplements. The 2 dietary supplements are table salt (sachet) or bottled water. They will be test in a cross-over design during 2 periods of 1 week separated from 1 week of a washing-out period.
The primary objective will be to compare mean arterial pressure (MAP) resulting from daily supplementation of 2.56 g of sodium (111 mmol), in addition to the food intake of a low-sodium diet from V2 to the end of the study (<5g of NaCl / day), for 7 days, either as sodium chloride or as sodium bicarbonate in hypertensive subjects.
This clinical trial will be separated in 2 phases:
- Phenotyping (4 visits): to determine if the volunteer is "NaCl sensitive volunteer" or not
- V1 (day -28/D-28) = inclusion and beginning of phenotyping phase,
- V2 (day -21/D-21) = start of a low-sodium diet (<5g of NaCl / day),
- V3 (day -14/D-14) = daily supplementation of sodium chloride for 7 days (9.78g/day),
- V4 (day -7/D-7) = "NaCl sensitive volunteer" assessment, end of study for "NaCl non-senstive volunteers".
- Treatment period for "NaCl sensitive volunteer" with dietary supplement intake in a cross-over design:
- PC1 (day 0/D0) = beginning of treatment period 1,
- PC2 (day 3/D3) = volunteer contact to make sure he is all right,
- V5 (day 7/D7) = end treatment period 1,
- PC3 (day 14/D14) = beginning of treatment period 2,
- PC4 (day 17/D17) = volunteer contact to make sure he is all right,
- V6 (day 21/D21) = end of treatment period 2 and of the study.
The protocol includes a total of 6 visits to PIC/CIC Inserm 1405 of the Clermont-Ferrand University Hospital.
The maximum duration of the study will be of 7 weeks.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Single-center, randomized study, organized in 2 stages.
| Arm | Type | Receives |
|---|---|---|
| Bottle of water | Experimental | Diagnostic Test: Phenotyping, Dietary Supplement: Drug intakeAfter inclusion in the study, the patients are phenotyped between V1 and V4. Following this, they will be separated into 2 groups: "NaCl sensitive" patients and "non-NaCl sensitive" patients. The non-sensitive group will drop out of the study, while the others will be randomized to one of the 2 treatment arms: bottle of water or sachet of salt. |
| Salt sachet | Active comparator | Diagnostic Test: Phenotyping, Dietary Supplement: Drug intakeAfter inclusion in the study, the patients are phenotyped between V1 and V4. Following this, they will be separated into 2 groups: "NaCl sensitive" patients and "non-NaCl sensitive" patients. The non-sensitive group will drop out of the study, while the others will be randomized to one of the 2 treatment arms: bottle of water or sachet of salt. |
| No treatment | Other | Diagnostic Test: PhenotypingAfter inclusion in the study, the patients are phenotyped between V1 and V4. Following this, they will be separated into 2 groups: "NaCl sensitive" patients and "non-NaCl sensitive" patients. The non-sensitive group will drop out of the study, while the others will be randomized to one of the 2 treatment arms: bottle of water or sachet of salt. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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,
Key exclusion criteria (20 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhenotypingAfter inclusion in the study, between V1 and V4, patients will be phenotyped among: "NaCl sensitive" patients and "non-NaCl sensitive" patients. they will have a low sodium diet for 2 weeks. The first week without salt supplementation and the second with salt supplementation. At the end of V4, if patient is "NaCl sensitive" he will continue into treatment period and go through randomization, and for patient "non-NaCl sensitive" they will drop out of study. | Diagnostic test | Bottle of water, No treatment, Salt sachet |
| Drug intakeAfter being phenotyped, "NaCl sensitive" patients will continue the study in one of the 2 treatments arms : royal water (bottle) or salt sachet. | Dietary supplement | Bottle of water, Salt sachet |
Primary outcome
Change from mean blood pressure (MBP) at Day 21
Time frame: Day 21
Comparison between blood pressure data recorded by the volunteer between the 2 weeks of treatment (measurement during 2 days before Day 7 and 2 days before Day 21). Recording of systolic and diastolic blood pressure will be made by the patient at home with the Microlife BP A200 device, in the morning and evening. Comparison of the data collected from these 2 weeks of treatment will allow us to meet the main objective of the study.
17 secondary outcomes
Change from mean blood pressure (MBP) at Day -7
Time frame: Day -7
Weight
Time frame: Day -28, Day -21, Day -14, Day -7, Day 7 and Day 21
Body composition analysis
Time frame: Day -21, Day -14, Day -7, Day 7 and Day 21
Optional genotyping
Time frame: One time at Day -28
Plasma renin dosage on fasted state
Time frame: Day -28, Day -14, Day -7, Day 7 and Day 21
Plasma Angiotensin II dosage on fasted state
Time frame: Day -28, Day -14, Day -7, Day 7 and Day 21
Plasma Aldosterone dosage on fasted state
Time frame: Day -28, Day -14, Day -7, Day 7 and Day 21
Plasma potassium dosage on fasted state
Time frame: Day -28, Day -14, Day -7, Day 7 and Day 21
Plasma sodium dosage on fasted state
Time frame: Day -28, Day -14, Day -7, Day 7 and Day 21
Plasma calcium dosage on fasted state
Time frame: Day -28, Day -14, Day -7, Day 7 and Day 21
Plasma chlorine dosage on fasted state
Time frame: Day -28, Day -14, Day -7, Day 7 and Day 21
Plasma protein dosage on fasted state
Time frame: Day -28, Day -14, Day -7, Day 7 and Day 21
Serum creatinine dosage on fasted state
Time frame: Day -28, Day -14, Day -7, Day 7 and Day 21
Serum urea dosage on fasted state
Time frame: Day -28, Day -14, Day -7, Day 7 and Day 21
Sodium concentration in 24h urine
Time frame: Day -28, Day -14, Day -7, Day 7 and Day 21
Potassium concentration in 24h urine
Time frame: Day -28, Day -14, Day -7, Day 7 and Day 21
Creatinine concentration in 24h urine
Time frame: Day -28, Day -14, Day -7, Day 7 and Day 21
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2021.
- Clinical trial link for previous clinical trial on the same subjectLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gisele PICKERING, MD principal investigator
Platform of Clinical Investigation/Clinical Investigation Center French Institute of Health and Medical Research-1405 63000 Clermont-Ferrand FRANCE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phenotyping and Drug intake in people with Hypertension, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lise LACLAUTRE, PharmD (04 73 75 11 95, drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from mean blood pressure (MBP) at Day 21 (time frame: Day 21). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2021.