Postnatal Enalapril to Improve Cardiovascular fUnction Following Preterm Pre-eclampsia
NCT03466333 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 118
Last updated 2021-02-24
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.
Conditions
- Cardiovascular Diseases
- Pre-Eclampsia Onset Less Than 37 Weeks (Diagnosis)
Interventions
- 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.
Sponsors & Collaborators
-
Manchester University NHS Foundation Trust
lead OTHER_GOV
Principal Investigators
-
Jenny Dr Myers, MBBS PhD · The University of Manchester
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 16 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-09-05
- Primary Completion
- 2020-09-11
- Completion
- 2020-09-11
Countries
- United Kingdom
Study Locations
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