Enalapril to improve heart function following preterm pre-eclampsia.

Phase 1

• Conditions: Postnatal (PN) cardiovascular dysfunction following preterm pre-eclampsia (pPE); MedDRA version: 20.0 Level: PT Classification code 10036485 Term: Pre-eclampsia System Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions; MedDRA version: 20.0 Level: LLT Classification code 10040444 Term: Severe pre-eclampsia System Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions; MedDRA version: 20.1 Level: LLT Classification code 10007648 Term: Cardiovascular disease, unspecified System Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2017-003180-35-GB
• Lead Sponsor: Manchester University NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-04-30
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

- Diagnosis of preterm pre-eclampsia (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 and/or low PlGF)
•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

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

•Inability to consent
•Known cardiac disease
•Contraindication to ACE inhibitors
•Current ACE inhibitor / ARB use
•Renal artery stenosis

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified