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Calcium Channel Blocker

NIFEdipine ER for Reducing High Blood Pressure After Preeclampsia (REPAIR Trial)

N/A

Recruiting

Led By Anna Palatnik, MD

Research Sponsored by Medical College of Wisconsin

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 - 50

Hypertensive disorders of pregnancy (HDP) diagnosis (gestational hypertension or preeclampsia) according to ACOG guidelines

Must not have

Pre-gestational diabetes (type 1 or type 2)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up after birth through one year postpartum

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to study the impact of closely monitoring and controlling blood pressure after giving birth on the overall heart health of mothers. The goal is to reduce the risk of developing long-term high blood pressure and

Who is the study for?

This trial is for women aged 18-50 who have had high blood pressure or preeclampsia during pregnancy, can communicate in English or Spanish, and are within the first three days after giving birth. It's not for those with pre-pregnancy hypertension or diabetes, planning to transfer hospitals postpartum, allergic to nifedipine, or unable to consent.

What is being tested?

The study tests whether intensive blood pressure control using NIFEdipine ER after childbirth can improve heart health, lower the risk of long-term high blood pressure, and reverse vascular damage caused by hypertensive disorders during pregnancy.

What are the potential side effects?

NIFEdipine ER may cause side effects such as headache, swelling of the ankles/feet (fluid retention), dizziness/lightheadedness due to low blood pressure, flushing (warmth/redness/itchy skin), fatigue and nausea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 50 years old.

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I was diagnosed with high blood pressure during pregnancy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I had diabetes before getting pregnant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one year postpartum

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one year postpartum

This trial's timeline: 3 weeks for screening, Varies for treatment, and one year postpartum for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Chronic hypertension

Secondary study objectives

ASCVD score

Arterial stiffness

Cardiac structure and function

+5 more

Other study objectives

Breastfeeding initiation and duration

Serum biomarkers of cardiovascular risk

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: REPAIR ARMExperimental Treatment1 Intervention

Intensive postpartum blood pressure control with nifedipine ER initiation at systolic blood pressure (SBP) ≥140 mmHg or diastolic blood pressure (DBP) ≥90 mmHg and maintaining blood pressure \<140/90 mmHg during the first 6 weeks postpartum.

Group II: CONTROL ARMActive Control1 Intervention

Usual care with nifedipine ER initiation at SBP ≥150 mmHg or DBP ≥100 mmHg and maintaining blood pressure \<150/100 mmHg during the first 6 weeks postpartum.

0 / 3Eligibility criteria met