NCT03466333

Postnatal Enalapril to Improve Cardiovascular fUnction Following Preterm Pre-eclampsia

Feasibility Study on the Effects of Postnatal Enalapril on Maternal Cardiovascular Function Following Preterm Pre-eclampsia.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 118 (actual)
• Sponsor: Manchester University NHS Foundation Trust · Other Government
• Sex: Female
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Pre-eclampsia (PE) is a condition in pregnancy, identified by a combination of high blood pressure and protein in the urine. It affects 3-5% pregnancies. Women with preterm PE (pPE; delivery before 37 weeks) frequently develop abnormal heart function after pregnancy, which increases their risk of heart disease in later life. Subtle changes in heart function have also been shown to increase the chance of a woman getting PE again in her next pregnancy. Despite this, research to date has focused on the pregnancy and relatively little is known about what happens after pregnancy and whether outcomes can be improved with treatment. sFlt is a protein that prevents blood vessel growth and causes blood vessel constriction. sFlt levels are raised in pPE and correlate with the degree of abnormal heart function. In animal studies, sFlt has been shown to directly cause injury to the heart and it is therefore possible that sFlt mediates pPE associated heart damage. Angiotensin converting enzyme (ACE) inhibitors are commonly used to protect against heart damage following myocardial infarction, but their use has never been tested following pPE. Objectives: 1. To characterise abnormal heart function following pPE 2. To determine if this can be modified by treatment with enalapril. Study design: Women who have had pPE, will be randomly allocated to enalapril or placebo from delivery for 6 months. Heart function will be assessed using blood tests and ultrasound scans (echocardiography). This will allow us to learn more about how pPE affects the heart (from the placebo group) and measure the protective effect of enalapril on the heart. Recruitment rates and acceptability of the intervention will also be assessed in this feasibility study.

Conditions

• Cardiovascular Diseases
• Pre-Eclampsia Onset Less Than 37 Weeks (Diagnosis)

Interventions

Type	Name	Description
DRUG	Enalapril Maleate	Enalapril maleate will be encapsulated; participants will take the drug once a day for 6 months following delivery.
DRUG	Placebo oral capsule	The placebo will be encapsulated; participants will take the drug once a day for 6 months following delivery. It will be identical in appearance to the IMP.

Timeline

• Start date: 2018-09-05
• Primary completion: 2020-09-11
• Completion: 2020-09-11
• First posted: 2018-03-15
• Last updated: 2021-02-24

Locations

1 site across 1 country: United Kingdom