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Response to angiotensin II in formerly preeclamptic women. RETAP study.

- candidate number8725
- NTR NumberNTR2635
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-dec-2010
- Secondary IDsNL3438704210 / 2010-294 ; CCMO / METC UMCG
- Public TitleResponse to angiotensin II in formerly preeclamptic women. RETAP study.
- Scientific TitleResponse to angiotenin II in formerly preeclamptic women. RETAP study.
- hypothesisIn this study, we will investigate whether formerly preeclamptic women exhibit increased angiotensin II sensitivity, which may attribute to renal dysfunction. Furthermore, we will investigate the renal hemodynamics in the short term following a preeclamptic pregnancy in relation to dietary sodium intake.
- Healt Condition(s) or Problem(s) studiedPre-eclampsia
- Inclusion criteria1. Healthy females with a history of normotensive pregnancy; with a range of one to five years after their pregnancy;
2. Participants with a history of severe preeclampsia; with a range of one to five years after their pregnancy;
3. ≥ 18 years of age;
4. Severe preeclampsia is defined according to ISSHP guidelines.
- Exclusion criteria1. Diabetes mellitus;
2. Diabetes gravidarum in healthy females groups;
3. BMI ≥ 30;
4. Oral contraceptive pill use which can't be temporally stopped;
5. Participants with renal diseases;
6. Participants with cardiovascular diseases;
7. Treatment with anti-hypertensive drug;
8. Blood pressure: systolic > 150, diastolic > 100 mmHg;
9. Pregnant or lactating women;
10. Any surgical or medical condition that in the opinion of the investigator would jeopardize the evaluation of efficacy or safety;
11. History of noncompliance to medical regimens and patients who are considered potentially unreliable.
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupCrossover
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 1-jan-2011
- planned closingdate1-jan-2013
- Target number of participants50
- InterventionsDuring one week women will use a low sodium diet (50 mmol sodium/day, 1.2 gram). This will be followed by a week of high sodium diet (200 mmol sodium/day, 4.8 gram) (with four weeks in between). On day 3 and day 6 of each dietary period subjects will collect 24-hour urine to assess dietary compliance and achievement of stable sodium balance.

At the end of both the low and the high sodium diet week, a day of renal function measurements will follow. Baseline blood pressure and renal function will be measured. GFR, ERPF, FF and ECV will be measured by constant infusion of radioactive-labelled tracers: 125-I-iothalamate and 131-I-hippurate. In the afternoon ang II will be infused at a rate of 0.3, 1 and 3 ng/kg/min all during one hour. Both blood pressure and renal hemodynamics will be measured during ang II infusion.
- Primary outcomePrimary endpoints will be renal (ERPF, GFR and FF) response and systemic response (bloodpressure) to angiotensin II after low and high sodium diet in formerly preeclamptic patients compared to healthy controls.
- Secondary outcomeSecondary endpoints will be renal function after preeclampsia, expressed as glomerular filtration rate (GFR), effective renal plasma flow (ERPF), filtration fraction (FF) and extracellular volume (ECV) and changes in RAAS-parameters (plasma renine activity, aldosteron, angiotensins, ACE-activity) in relation to sodiumintake, in formely preeclamptic patients compared to healthy controls.
- TimepointsThe study design of this study is a patient-control, cross over study, with a study day after a week of low sodium intake and a week of high sodium intake, with four weeks in between.
- Trial web siteN/A
- statusplanned
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG)
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD2-dec-2010 - 15-dec-2010

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