Cardiovascular Protection After Preeclampsia With Enalapril (CAPP-E)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypertension; Preeclampsia; Hypertensive Disorder of Pregnancy; Gestational Hypertension; Gestational Hypertension After Childbirth
• Intervention / Treatment: Drug: Enalapril; Other: Standard treatment

Detailed Description

Cardiovascular disease (CVD) is the leading cause of death in women worldwide, and despite declines in all other age groups, mortality rates attributed to CVD are increasing in women of childbearing age. Hypertensive disorders of pregnancy (HDP), including preeclampsia and gestational hypertension, are well-established risk factors for CVD across diverse patient populations. There is compelling evidence that the preponderance of HDP-associated CVD risk is linked to progression to chronic hypertension following pregnancy. Thus, the postpartum period after HDP is a critical yet under-studied opportunity for intervention to prevent chronic disease in women.

One intervention that may reduce the chance of progression to CVD is the institution of anti-hypertensive medications. The cornerstones of current postpartum anti-hypertensive treatment are labetalol (a dual β- and α-adrenergic receptor blocker) and nifedipine (a calcium channel blocker), primarily due to their well-documented safety profile during pregnancy and obstetricians' comfort with their dosing. However, there are significant limitations in the current standard of care for anti-hypertensive treatment postpartum, including (1) two to three times per day dosing, (2) significant side effects, and (3) lack of endothelial or cardioprotective effects. Further, there is some evidence that these medications may not be as efficacious as some others.

Angiotensin-converting enzyme (ACE) inhibitors are anti-hypertensive agents that provide cardioprotection through anti-inflammatory effects, increased nitric oxide bioavailability, and diminished fibrosis. Because of these benefits, they are recommended in non-pregnant / postpartum individuals who have heart failure or myocardial infarction to reduce cardiovascular mortality. Enalapril is a type of ACE- inhibitor that is taken daily or twice daily with minimal side effects, is a highly effective anti-hypertensive agent, and has a reassuring lactation safety profile, making it an ideal candidate for postpartum treatment after preeclampsia.

The overall objective of this application is to conduct a single-site RCT, which will enroll individuals within the institution's remote blood pressure (BP) management program, to allow the collection of key data that will inform a future NIH-funded RCT. The' central hypothesis is that an RCT evaluating enalapril versus standard-of-care treatments will be feasible, and that enalapril will improve blood pressure at 4 months after delivery. The investigators will test this hypothesis by pursuing the following specific aims:

Aim 1. Determine the feasibility of conducting a randomized controlled trial of enalapril versus current standard of care (labetalol or nifedipine) in postpartum individuals who have had a hypertensive disorder of pregnancy.

Aim 2. Determine whether enalapril versus standard of care improves blood pressure at 4 months postpartum.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Alisse Hauspurg, MD; Phone Number: 47451 401-274-1122; Email: ahauspurg@carene.org
• Study Contact Backup: Name: Crystal Ware, RN; Email: cware@wihri.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Enalapril; First-line anti-hypertensive treatment with enalapril	Drug: Enalapril; First-line anti-hypertensive treatment with enalapril
Active Comparator: Standard treatment; First-line anti-hypertensive treatment with standard of care treatment	Other: Standard treatment; First-line anti-hypertensive treatment per standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure	Systolic and diastolic blood pressure	4 months
Blood pressure	Systolic and diastolic blood pressure	6 weeks
Mean home blood pressure	Mean systolic and diastolic blood pressure	6 weeks
Mean arterial pressure	Mean arterial blood pressure	4 months
Mean arterial pressure	Mean arterial blood pressure	6 weeks
Quantification of anti-hypertensive agents through study period using therapeutic intensity score	Throughout study period	4 months
Use of anti-hypertensive agents	At study completion	4 months
Medication side effects	Throughout study period	4 months

Collaborators and Investigators

• Sponsor: Women and Infants Hospital of Rhode Island
• Investigators: Principal Investigator: Alisse Hauspurg, MD, WOMEN AND INFANTS HOSPITAL-RHODE ISLAND

Study record dates

Study Major Dates

• Study Start (Estimated): November 15, 2025
• Primary Completion (Estimated): October 15, 2027
• Study Completion (Estimated): October 15, 2027

Study Registration Dates

• First Submitted: October 2, 2025
• First Submitted That Met QC Criteria: October 29, 2025
• First Posted (Estimated): October 30, 2025

Study Record Updates

• Last Update Posted (Estimated): October 30, 2025
• Last Update Submitted That Met QC Criteria: October 29, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: postpartum hypertension, preeclampsia, gestational hypertension
• Additional Relevant MeSH Terms: Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Infections; Pre-Eclampsia; Hypertension, Pregnancy-Induced; Hypertension; Toxemia; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Dipeptides; Enalapril
• Other Study ID Numbers: 2310266-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: after publication of primary manuscript
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes