Cardiovascular Protection After Preeclampsia With Enalapril
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Enalapril, Standard treatment.
- Who it may be relevant to
- Registry conditions: Preeclampsia, Hypertensive Disorder of Pregnancy, Hypertension, Gestational Hypertension. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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.
Interventions
- Drug Enalapril
First-line anti-hypertensive treatment with enalapril - Other Standard treatment
First-line anti-hypertensive treatment per standard of care
Primary outcome measures
- Feasibility of enrollment [Time frame: 4 months]
- Feasibility of retention [Time frame: 4 months]
Secondary outcome measures (8)
- Blood pressure [Time frame: 4 months]
- Blood pressure [Time frame: 6 weeks]
- Mean home blood pressure [Time frame: 6 weeks]
- Mean arterial pressure [Time frame: 4 months]
- Mean arterial pressure [Time frame: 6 weeks]
- Quantification of anti-hypertensive agents through study period using therapeutic intensity score [Time frame: 4 months]
- Use of anti-hypertensive agents [Time frame: 4 months]
- Medication side effects [Time frame: 4 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Women and Infants Hospital — Providence
Identifiers
NCT: NCT07222852 · 2310266-3