Postnatal Enalapril to Improve Cardiovascular fUnction Following Preterm Pre-eclampsia

NCT03466333 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2021-02-24

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03466333 on ClinicalTrials.gov