PreeclampsiaPhase 3CAPP-ENCT07222852
Cardiovascular Protection After Preeclampsia With Enalapril
A Phase 3 study testing Enalapril and Standard treatment in people with Preeclampsia and Hypertensive Disorder of Pregnancy, run by Women and Infants Hospital of Rhode Island at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preeclampsia, Hypertensive Disorder of Pregnancy, Hypertension
- What is being tested?
- Enalapril and Standard treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2026to 15 Oct 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postpartum individuals
- ≥18 years old
- Hypertensive disorder of pregnancy
- Enrolled in Women and Infants Hospital Hypertension Equity remote monitoring program.
Who cannot join
- Maternal cardiac disease
- Individuals with pre-pregnancy hypertension or diabetes
- Allergy or contraindication to enalapril
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Crystal Ware, RN contact
United States1 site, 1 recruiting
- Recruiting
Women and Infants Hospital
Providence, Rhode Island, 02906
Alisse Hauspurg, MD, MS, 401-274-1122, ahauspurg@carene.org
About this study
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.
Read the 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.
- Conditions
- Preeclampsia, Hypertensive Disorder of Pregnancy, Hypertension, Gestational Hypertension, Gestational Hypertension After Childbirth
- Being tested
- Enalapril, Standard treatment
- Keywords
- postpartum hypertension, preeclampsia, gestational hypertension
- Medical subject headings
- Pre-Eclampsia, Toxemia, Hypertension, Hypertension, Pregnancy-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnalaprilDrug
First-line anti-hypertensive treatment with enalapril
Standard treatmentOther
First-line anti-hypertensive treatment per standard of care
| Study group | Role | What they receive |
|---|---|---|
| Enalapril | Experimental | First-line anti-hypertensive treatment with enalapril Receives: Drug: Enalapril |
| Standard treatment | Active comparator | First-line anti-hypertensive treatment with standard of care treatment Receives: Other: Standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of enrollment
Proportion of approached individuals who are enrolled
Measured: 4 months
Feasibility of retention
Retention of participants to 4 months postpartum
Measured: 4 months
Secondary outcomes (8)
Blood pressure
Systolic and diastolic blood pressure
Measured: 4 months
Blood pressure
Systolic and diastolic blood pressure
Measured: 6 weeks
Mean home blood pressure
Mean systolic and diastolic blood pressure
Measured: 6 weeks
Mean arterial pressure
Mean arterial blood pressure
Measured: 4 months
Mean arterial pressure
Mean arterial blood pressure
Measured: 6 weeks
Quantification of anti-hypertensive agents through study period using therapeutic intensity score
Throughout study period
Measured: 4 months
Use of anti-hypertensive agents
At study completion
Measured: 4 months
Medication side effects
Throughout study period
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2025
- Study start1 Jan 2026
- Primary completion15 Oct 2027 (estimated)
- Study completion15 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women and Infants Hospital of Rhode Island
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alisse Hauspurg, MD, Principal investigator, WOMEN AND INFANTS HOSPITAL-RHODE ISLAND
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07222852
- Sponsor's protocol ID
- 2310266-3
- Acronym
- CAPP-E
- Status last verified
- Apr 2026
- First submitted
- 2 Oct 2025
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Protection After Preeclampsia With Enalapril
- ClinicalTrials.gov ID
- NCT07222852
- Acronym / sponsor ID
- CAPP-E / 2310266-3
- Conditions
- Preeclampsia, Hypertensive Disorder of Pregnancy, Hypertension, Gestational Hypertension, Gestational Hypertension After Childbirth
- Keywords
- postpartum hypertension, preeclampsia, gestational hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Women and Infants Hospital of Rhode IslandUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 15 Oct 2027 (estimated)
- Study completion
- 15 Oct 2027 (estimated)
- First posted
- 30 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enalapril | Experimental | Drug: EnalaprilFirst-line anti-hypertensive treatment with enalapril |
| Standard treatment | Active comparator | Other: Standard treatmentFirst-line anti-hypertensive treatment with standard of care treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Postpartum individuals
- ≥18 years old
- Hypertensive disorder of pregnancy
- Enrolled in Women and Infants Hospital Hypertension Equity remote monitoring program.
Key exclusion criteria (3 listed)
- Maternal cardiac disease
- Individuals with pre-pregnancy hypertension or diabetes
- Allergy or contraindication to enalapril
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EnalaprilFirst-line anti-hypertensive treatment with enalapril | Drug | Enalapril |
| Standard treatmentFirst-line anti-hypertensive treatment per standard of care | Other | Standard treatment |
Primary outcome
Feasibility of enrollment
Time frame: 4 months
Proportion of approached individuals who are enrolled
Feasibility of retention
Time frame: 4 months
Retention of participants to 4 months postpartum
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: Yes
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Preeclampsia
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Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Crystal Ware, RN contact
Alisse Hauspurg, MD principal investigator
WOMEN AND INFANTS HOSPITAL-RHODE ISLAND
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Enalapril and Standard treatment in people with Preeclampsia and Hypertensive Disorder of Pregnancy, run by Women and Infants Hospital of Rhode Island at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alisse Hauspurg, MD (401-274-1122 ext. 47451, ahauspurg@carene.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of enrollment (time frame: 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.