Postnatal Enalapril to Improve Cardiovascular fUnction Following Preterm Pre-eclampsia

• Status: Completed
• Trial end date: 2020-09-11
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Manchester University NHS Foundation Trust
• Treatments: Enalapril; Enalaprilat; Maleic acid

Criteria

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