PreeclampsiaNCT01874990
Increased Salt Sensitivity of Ambulatory Blood Pressure in Women With a History of Severe Preeclampsia
A study testing high sodium diet and low-salt diet in people with Preeclampsia, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
Cardiovascular diseases are the principal cause of death in women in developed and developing countries and are importantly promoted by hypertension. Salt sensitivity of the blood pressure is considered as an important cardiovascular risk factor at any blood pressure level. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preeclampsia
- What is being tested?
- high sodium diet and low-salt diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- Dec 2009to Dec 2012
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- women with history of severe preeclampsia (systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥110 mmHg with severe proteinuria (≥ 5g /24h or 3+ dipstick) and one or more signs of multisystem disease developing after 20 weeks of gestation in previously normotensive women.
- or
- women who had a premature delivery (<34 weeks) in the context of preeclampsia (systolic blood pressure ≥140mmHg and/or diastolic blood pressure ≥90 mmHg with severe proteinuria (≥ 300 mg /24h or 1+ dipstick)
- age ≤ 50 years
- controls : women and who delivered at term (> 37 weeks) without pre-eclampsia
Who cannot join
- History of :
- hypertension
- diabetes mellitus
- renal or cardiac impairment
- polycystic ovary syndrome
- recent or actual use of anti-inflammatory drugs, diuretics, aspirin, oral contraceptives and hormonal replacement therapy
Trial locations and contacts
1 site in 1 country.
About this study
Cardiovascular diseases are the principal cause of death in women in developed and developing countries and are importantly promoted by hypertension. Salt sensitivity of the blood pressure is considered as an important cardiovascular risk factor at any blood pressure level. Severe preeclampsia is a hypertensive disorder of the pregnancy that also arises as a risk factor for cardiovascular and renal diseases.
The major aim of this study is to examine the salt sensitivity of the ambulatory blood pressure in women with a history of severe preeclampsia (< 34 weeks gestation) compared with women with no history of pregnancy-related hypertensive complications. We plan to recruit 20 non-menopausal women with a history of severe preeclampsia, and 20 age, parity, race- matched premenopausal women as controls. The study has a case control randomized design. The salt sensitivity of the ambulatory blood pressure is defined as an increase of ≥4 mmHg in 24h ambulatory blood pressure on a high sodium diet. The high sodium diet is obtained by adding capsules of 6gr of NaCl/ day in the usual diet.
The participants are identified as women discharged from the Maternity of University Hospital of Geneva between 1999 and 2001 with a preeclampsia coding. Fetal and maternal data will be carefully recovered from hospital records to identify severe preeclampsia (PE), based on International Society for the Study of Hypertension in Pregnancy criteria. These criteria are systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥110 mmHg with severe proteinuria (≥ 5g /24h or 3+ dipstick) and one or more signs of multisystem disease developing after 20 weeks of gestation in previously normotensive women. Severe preeclampsia was also defined as occurring before 34wk of gestation. Women with a history of hypertension, diabetes mellitus, renal or cardiac impairment, polycystic ovary syndrome will be excluded. Other exclusion criteria are anti-inflammatory drugs, diuretics, aspirin, oral contraceptives and hormonal replacement therapy. The protocol is approved by the University Hospital Ethical Committee and written informed consent will be obtained from each individual in accordance with the declaration of Helsinki. The study is conducted between 2009 and 2012 at the University Hospitals of Geneva, Switzerland.
- Conditions
- Preeclampsia
- Being tested
- high sodium diet, low-salt diet
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high sodium dietDietary supplement
The high-sodium diet was obtained by adding 6g of sodium chloride to the individual's regular diet
low-salt dietDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| women with a history of severe preeclampsia | Experimental | women with a history of severe preeclampsia(< 34 weeks gestation) between 5 and 10 years ago Receives: Dietary Supplement: high sodium diet; Dietary Supplement: low-salt diet |
| control | Experimental | women with no history of pregnancy-related hypertensive complications Receives: Dietary Supplement: high sodium diet; Dietary Supplement: low-salt diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
salt sensitivity of the ambulatory blood pressure in women with a history of severe preeclampsia (< 34 weeks gestation) compared with women with no history of pregnancy-related hypertensive complications
The women receive a low-sodium (LS) and a high-sodium (HS) diet for 1 week. The sequence of the diets is randomized in order to prevent a sequence effect. Between the two periods, they retain their usual diet for 3 weeks. The high-sodium diet is obtained by adding 6g of sodium chloride to the individual's regular diet. On day 7 of each dietary period, 24h ambulatory BP is recorded. Automated measurements are performed every 30 min intervals from 08:00 to 22:00 hours and at 60 min from 22:00 to 08:00 hours. The primary measure outcome is the response of the mean, or systolic, or diastolic ambulatory blood pressure to a high salt diet compared with low salt diet in PEC women and in controls. Salt-sensitivity is defined by an increase of at least 4 mmHg on a high salt diet.
Measured: evaluation at 5wk
Secondary outcomes (1)
Variability of the ambulatory blood pressure on a high salt diet
A secondary outcome measure will be to assess the variability of the ambulatory blood pressure on differents salt diets, assessed by the standard deviation of the BP
Measured: evaluation at 5wk
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2013 (estimated)
- Study startDec 2009
- Primary completionNov 2011
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antoinette Pechere-Bertschi, MD, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01874990
- Sponsor's protocol ID
- Preeclampsia &salt sensitivity
- Status last verified
- Apr 2013
- First submitted
- 6 Apr 2013
- Last updated
- 11 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increased Salt Sensitivity of Ambulatory Blood Pressure in Women With a History of Severe Preeclampsia
- ClinicalTrials.gov ID
- NCT01874990
- Acronym / sponsor ID
- Preeclampsia &salt sensitivity
- Conditions
- Preeclampsia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 11 Jun 2013 (estimated)
- 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.
Cardiovascular diseases are the principal cause of death in women in developed and developing countries and are importantly promoted by hypertension. Salt sensitivity of the blood pressure is considered as an important cardiovascular risk factor at any blood pressure level. Severe preeclampsia is a hypertensive disorder of the pregnancy that also arises as a risk factor for cardiovascular and renal diseases.
The major aim of this study is to examine the salt sensitivity of the ambulatory blood pressure in women with a history of severe preeclampsia (< 34 weeks gestation) compared with women with no history of pregnancy-related hypertensive complications. We plan to recruit 20 non-menopausal women with a history of severe preeclampsia, and 20 age, parity, race- matched premenopausal women as controls. The study has a case control randomized design. The salt sensitivity of the ambulatory blood pressure is defined as an increase of ≥4 mmHg in 24h ambulatory blood pressure on a high sodium diet. The high sodium diet is obtained by adding capsules of 6gr of NaCl/ day in the usual diet.
The participants are identified as women discharged from the Maternity of University Hospital of Geneva between 1999 and 2001 with a preeclampsia coding. Fetal and maternal data will be carefully recovered from hospital records to identify severe preeclampsia (PE), based on International Society for the Study of Hypertension in Pregnancy criteria. These criteria are systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥110 mmHg with severe proteinuria (≥ 5g /24h or 3+ dipstick) and one or more signs of multisystem disease developing after 20 weeks of gestation in previously normotensive women. Severe preeclampsia was also defined as occurring before 34wk of gestation. Women with a history of hypertension, diabetes mellitus, renal or cardiac impairment, polycystic ovary syndrome will be excluded. Other exclusion criteria are anti-inflammatory drugs, diuretics, aspirin, oral contraceptives and hormonal replacement therapy. The protocol is approved by the University Hospital Ethical Committee and written informed consent will be obtained from each individual in accordance with the declaration of Helsinki. The study is conducted between 2009 and 2012 at the University Hospitals of Geneva, Switzerland.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| women with a history of severe preeclampsia | Experimental | Dietary Supplement: high sodium diet, Dietary Supplement: low-salt dietwomen with a history of severe preeclampsia(< 34 weeks gestation) between 5 and 10 years ago |
| control | Experimental | Dietary Supplement: high sodium diet, Dietary Supplement: low-salt dietwomen with no history of pregnancy-related hypertensive complications |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- women with history of severe preeclampsia (systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥110 mmHg with severe proteinuria (≥ 5g /24h or 3+ dipstick) and one or more signs of multisystem disease developing after 20 weeks of gestation in previously normotensive women.
- or
- women who had a premature delivery (<34 weeks) in the context of preeclampsia (systolic blood pressure ≥140mmHg and/or diastolic blood pressure ≥90 mmHg with severe proteinuria (≥ 300 mg /24h or 1+ dipstick)
- age ≤ 50 years
- controls : women and who delivered at term (> 37 weeks) without pre-eclampsia
Key exclusion criteria (6 listed)
- hypertension
- diabetes mellitus
- renal or cardiac impairment
- polycystic ovary syndrome
- recent or actual use of anti-inflammatory drugs, diuretics, aspirin, oral contraceptives and hormonal replacement therapy
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 |
|---|---|---|
| high sodium dietThe high-sodium diet was obtained by adding 6g of sodium chloride to the individual's regular diet | Dietary supplement | control, women with a history of severe preeclampsia |
| low-salt diet | Dietary supplement | control, women with a history of severe preeclampsia |
Primary outcome
salt sensitivity of the ambulatory blood pressure in women with a history of severe preeclampsia (< 34 weeks gestation) compared with women with no history of pregnancy-related hypertensive complications
Time frame: evaluation at 5wk
The women receive a low-sodium (LS) and a high-sodium (HS) diet for 1 week. The sequence of the diets is randomized in order to prevent a sequence effect. Between the two periods, they retain their usual diet for 3 weeks. The high-sodium diet is obtained by adding 6g of sodium chloride to the individual's regular diet. On day 7 of each dietary period, 24h ambulatory BP is recorded. Automated measurements are performed every 30 min intervals from 08:00 to 22:00 hours and at 60 min from 22:00 to 08:00 hours. The primary measure outcome is the response of the mean, or systolic, or diastolic ambulatory blood pressure to a high salt diet compared with low salt diet in PEC women and in controls. Salt-sensitivity is defined by an increase of at least 4 mmHg on a high salt diet.
1 secondary outcome
Variability of the ambulatory blood pressure on a high salt diet
Time frame: evaluation at 5wk
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high sodium diet and low-salt diet in people with Preeclampsia, run by University Hospital, Geneva at 1 site in Switzerland.
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 5 inclusion and 6 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: finished, as of the sponsor's last update on 11 Jun 2013. 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
salt sensitivity of the ambulatory blood pressure in women with a history of severe preeclampsia (< 34 weeks gestation) compared with women with no history of pregnancy-related hypertensive complications (time frame: evaluation at 5wk). 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 11 Jun 2013.