Nifedipine vs Enalapril for Postpartum Hypertension

(PEACE Trial)

Overseen By Joshua Dahlke, MD

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: Nebraska Methodist Health System

Disqualifiers: Contraindication to medications, Heart rate, Language

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

850 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two medications, nifedipine (a calcium channel blocker) and enalapril (an ACE inhibitor), to evaluate their effectiveness in managing high blood pressure (hypertension) after childbirth. The goal is to determine if both medicines can safely and effectively control blood pressure and reduce hospital readmissions. Women admitted for delivery with high blood pressure, either from pregnancy or a pre-existing condition, may be suitable candidates for this study. Participants will be randomly assigned to start one of the two medications, while their primary healthcare provider will make all other treatment decisions. As a Phase 4 trial, this study involves FDA-approved treatments and aims to understand how these medications can benefit more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications. The decision to stop or change any medication will be made by your primary healthcare provider.

What is the safety track record for these treatments?

Research shows that nifedipine is a well-tolerated medication for managing high blood pressure, especially after childbirth. It is often preferred over labetalol for postpartum high blood pressure because it results in fewer hospital readmissions. Nifedipine is already approved for other conditions like angina (chest pain due to reduced blood flow to the heart) and long-term high blood pressure, which supports its safety.

Studies indicate that enalapril is commonly used to treat high blood pressure in new mothers, including those who are breastfeeding. However, reports have noted negative effects when ACE inhibitors like enalapril are used during pregnancy. Therefore, enalapril is recommended only after childbirth, not during pregnancy.

Both medications have a history of safe use in women after childbirth. However, it is important to monitor and consult with healthcare providers for safety. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about Nifedipine XR and Enalapril for postpartum hypertension because they offer distinct approaches to managing this condition. Unlike many standard treatments that mainly focus on diuretics or beta-blockers, Nifedipine XR works as a calcium channel blocker, which helps relax and dilate blood vessels, potentially offering faster relief. Enalapril, on the other hand, is an ACE inhibitor that reduces the production of chemicals that tighten blood vessels, thereby lowering blood pressure. These mechanisms of action provide alternative pathways to control blood pressure, which could be particularly beneficial for postpartum women who need effective and safe options.

What evidence suggests that this trial's treatments could be effective for postpartum hypertension?

This trial will compare the effectiveness of Nifedipine and Enalapril in managing postpartum hypertension. Research has shown that Nifedipine can reduce the likelihood of hospital readmission for high blood pressure issues after childbirth by up to 65% when used alone. Enalapril, another treatment option in this trial, has also been studied for postpartum hypertension and works similarly to Nifedipine. In one study, 66% of patients taking Nifedipine and 64% of those taking Enalapril achieved the primary treatment goal, indicating that both are equally effective. Both medications are considered safe and effective for managing high blood pressure after delivery. ^{1 4 6 7 8}

Who Is on the Research Team?

Todd Lovgren, MD

Principal Investigator

Nebraska Methodist Health System

Are You a Good Fit for This Trial?

This trial is for women who have given birth and are dealing with high blood pressure, either chronic or related to pregnancy. They must be at least 24 weeks into their gestation period. The study aims to see if two different blood pressure medications are equally good at preventing hospital readmission.

Inclusion Criteria

I am admitted for delivery, either by cesarean or vaginal method.

I am at least 24 weeks pregnant.

I have high blood pressure related to pregnancy or chronic hypertension.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either nifedipine or enalapril for management of postpartum hypertension

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on hospital readmission rates

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Enalapril
• Nifedipine

Trial Overview The trial compares the effectiveness of Enalapril (10mg daily) and Nifedipine (30mg twice a day) in managing postpartum hypertension. It's an open-label study where participants know which medication they're taking, but it's randomized so the assignment is by chance.

How Is the Trial Designed?

Group I: Enalapril 10mg QD Experimental Treatment 1 Intervention

Patients will be administered 10mg enalapril daily. Any additional intervention or changes in management of their hypertension will be at the discretion of their primary provider.

Group II: Nifedipine XR Active Control 1 Intervention

Patients will be randomized to receive nifedipine 30mg XR BID. Any additional changes in treatment will be at the discretion of their provider.

Who Is Running the Clinical Trial?

Nebraska Methodist Health System

Lead Sponsor

Trials

3

Recruited

760+

Methodist Hospital Foundation

Collaborator

Citations

1. ahajournals.org ahajournals.org/doi/10.1161/HYPERTENSIONAHA.120.15875

Postnatal Enalapril to Improve Cardiovascular Function ... The primary clinical outcome was reduction in TVR from baseline to 6 months postrandomization following treatment with enalapril, compared with ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37806651/

A randomized controlled trial comparing the efficacy of ... The primary outcome occurred in 31 of 47 patients (66%) randomized to the nifedipine group and in 30 of 47 (64%) randomized to the enalapril group (P=.83).

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07023003?intr=ENALAPRILAT&aggFilters=studyType:int&viewType=Table&rank=7

Postpartum Evaluation of Nifedipine and Enalapril for ... This is an open label, randomized controlled trial designed to compare nifedipine and enalapril in the management of postpartum hypertension. This is an ...

4. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.124.073302

Hypertension in Pregnancy and Postpartum Data from the United States highlight favorable outcomes for postpartum HBPM compared with usual care.

5. bmjopen.bmj.com bmjopen.bmj.com/content/14/12/e086208

Oral antihypertensive agents and diuretics in the ... With this review, we aim to investigate which antihypertensive agent results in optimal treatment of postpartum hypertension (both effectiveness and safety) and ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0146280625002105

Lactation-Safe Choices, Treatment Thresholds, and ... For lactating patients, nifedipine ER/amlodipine, enalapril, and labetalol are appropriate first-line choices; real-world data favor nifedipine ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9207847/

Best Practices for Managing Postpartum Hypertension - PMC Patients remain at risk for persistent and de novo postpartum hypertension related to pregnancy. This review aims to summarize the current ...

8. assessments.epa.gov assessments.epa.gov/risk/document/&deid%3D120705

Adverse Pregnancy Outcomes Associated With Maternal ... Adverse birth outcomes following the use of ACE inhibitors, including enalapril, during pregnancy have been reported in case histories and descriptive studies.