Increased Salt Sensitivity of Ambulatory Blood Pressure in Women With a History of Severe Preeclampsia
Primary Purpose
Preeclampsia
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
high sodium diet
low-salt diet
Sponsored by
About this trial
This is an interventional prevention trial for Preeclampsia
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
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
Sites / Locations
- University Hospitals
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
women with a history of severe preeclampsia
control
Arm Description
women with a history of severe preeclampsia(< 34 weeks gestation) between 5 and 10 years ago
women with no history of pregnancy-related hypertensive complications
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT01874990
First Posted
April 6, 2013
Last Updated
June 6, 2013
Sponsor
University Hospital, Geneva
1. Study Identification
Unique Protocol Identification Number
NCT01874990
Brief Title
Increased Salt Sensitivity of Ambulatory Blood Pressure in Women With a History of Severe Preeclampsia
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Geneva
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preeclampsia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
women with a history of severe preeclampsia
Arm Type
Experimental
Arm Description
women with a history of severe preeclampsia(< 34 weeks gestation) between 5 and 10 years ago
Arm Title
control
Arm Type
Experimental
Arm Description
women with no history of pregnancy-related hypertensive complications
Intervention Type
Dietary Supplement
Intervention Name(s)
high sodium diet
Intervention Description
The high-sodium diet was obtained by adding 6g of sodium chloride to the individual's regular diet
Intervention Type
Dietary Supplement
Intervention Name(s)
low-salt diet
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
evaluation at 5wk
Secondary Outcome Measure Information:
Title
Variability of the ambulatory blood pressure on a high salt diet
Description
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
Time Frame
evaluation at 5wk
Other Pre-specified Outcome Measures:
Title
occurence of a cardiovascular event in women having suffered from a preeclampsia
Description
we will assess at 5 years, the time between the delivery and the occurence of a cardiovascular event in post-preeclamptic women depending of their salt-sensitivity.
Time Frame
5 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Facility Information:
Facility Name
University Hospitals
City
Geneva 14
ZIP/Postal Code
1211
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Increased Salt Sensitivity of Ambulatory Blood Pressure in Women With a History of Severe Preeclampsia
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