CompletedPhase 2

Postnatal Enalapril to Improve Cardiovascular fUnction Following Preterm Pre-eclampsia

United Kingdom118 participantsStarted 2018-09-05

Plain-language summary

This is a double blind randomised controlled feasibility study investigating the effect of postnatal enalapril on cardiovascular function in women who have had preterm pre-eclampsia. Participants will be randomised to 6 months of enalapril or placebo within 3 days of delivery. Cardiovascular function will be assessed using serial echocardiography and biomarkers.

Who can participate

Age range

16 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Diagnosis of pPE in this pregnancy requiring delivery \< 37 weeks gestation: new or worsening hypertension \>20 weeks with proteinuria or other features suggestive of PE (abnormal haematological, biochemical parameters, fetal growth restriction (FGR) and/or abnormal sFlt:PlGF (\>85)). * Biochemical / haematological cut-offs: * Platelet count \<100 x109/L * Alanine amino transferase \> 50units/L * Creatinine \>90mmol/L * FGR: * Abdominal circumference (AC) / estimated fetal weight (EFW) \<3rd centile * Or 2 of the following: * AC/EFW \<10th centile * AC/EFW crossing centiles by \>2 quartiles * Cerebroplacental ratio \<5th centile * Umbilical artery PI \>95th centile * At time of randomisation: * Postpartum, within 3 days of delivery * Aged 18 years or over * Able to provide informed consent * Serum creatinine \<100 mmol/l Exclusion Criteria: * Inability to consent * Known cardiac disease * Contraindication to ACE inhibitors * Renal artery stenosis

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Process outcome

Timeframe: 24 months

Clinical outcome

Timeframe: 32 months

Trial details

NCT IDNCT03466333

SponsorManchester University NHS Foundation Trust

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2020-09-11

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