Cardiovascular Protection After Preeclampsia With Enalapril

NCT07222852 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: 2310266-3
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to learn if postpartum women are willing to be randomized to different blood pressure medicines after delivery and how that affects blood pressure in women with hypertensive disorders of pregnancy.

Conditions

Preeclampsia; Hypertensive Disorder of Pregnancy; Hypertension; Gestational Hypertension; Gestational Hypertension After Childbirth

Keywords

postpartum hypertension, preeclampsia, gestational hypertension

Outcome Measures

Primary Outcomes (2)

• Feasibility of enrollment

  Proportion of approached individuals who are enrolled

  4 months

• Feasibility of retention

  Retention of participants to 4 months postpartum

  4 months

Secondary Outcomes (8)

• Blood pressure

  4 months

• Blood pressure

  6 weeks

• Mean home blood pressure

  6 weeks

• Mean arterial pressure

  4 months

• Mean arterial pressure

  6 weeks

Study Arms (2)

Enalapril

EXPERIMENTAL

First-line anti-hypertensive treatment with enalapril

Drug: Enalapril

Standard treatment

ACTIVE COMPARATOR

First-line anti-hypertensive treatment with standard of care treatment

Other: Standard treatment

Interventions

Enalapril DRUG

First-line anti-hypertensive treatment with enalapril

Enalapril

Standard treatment OTHER

First-line anti-hypertensive treatment per standard of care

Standard treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Postpartum individuals
• ≥18 years old
• Hypertensive disorder of pregnancy
• Enrolled in Women and Infants Hospital Hypertension Equity remote monitoring program.

You may not qualify if:

• Maternal cardiac disease
• Individuals with pre-pregnancy hypertension or diabetes
• Allergy or contraindication to enalapril

Sponsors & Collaborators

• Women and Infants Hospital of Rhode Island: lead

Study Sites (1)

Women and Infants Hospital

Providence, Rhode Island, 02906, United States

RECRUITING

MeSH Terms

Conditions

Pre-Eclampsia; Toxemia; Hypertension; Hypertension, Pregnancy-Induced

Interventions

Enalapril

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Infections; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dipeptides; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Alisse Hauspurg, MD

  WOMEN AND INFANTS HOSPITAL-RHODE ISLAND

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alisse Hauspurg, MD

CONTACT

401-274-1122; ahauspurg@carene.org

Crystal Ware, RN

CONTACT

cware@wihri.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2025
• First Posted: October 30, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): October 15, 2027
• Study Completion (Estimated): October 15, 2027
• Last Updated: August 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: after publication of primary manuscript

Locations

US (1)