PICk-UP
Research type
Research Study
Full title
Feasibility study on the effects of postnatal enalapril on maternal cardiovascular function following preterm pre-eclampsia
IRAS ID
230484
Contact name
Laura Ormesher
Contact email
Sponsor organisation
Manchester University NHS Foundation Trust
Eudract number
2017-003180-35
Duration of Study in the UK
3 years, 6 months, 0 days
Research summary
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% of 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.REC name
North West - Haydock Research Ethics Committee
REC reference
18/NW/0253
Date of REC Opinion
15 Jun 2018
REC opinion
Further Information Favourable Opinion