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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON26813

Enrollment

Registered

2010-12-02

Start date

2011-01-01

Completion date

Unknown

Last updated

2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Formerly preeclamptic women

Interventions

During 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 da

Eligibility

Inclusion criteria

Inclusion criteria: 1. 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 criteria

Exclusion criteria: 1. 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.

Design outcomes

Primary

Measure	Time frame
Primary 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

Measure	Time frame
Secondary 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.	—

Contacts

Public ContactA.T. Lely

Hanzeplein 1

a.t.lely@og.umcg.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)