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Hypertension, Pregnancy-InducedREPAIRNCT06220721

Reducing the Risk of Chronic Hypertension and Improving Vascular Function Following Preeclampsia

A study testing Nifedipine ER in people with Hypertension, Pregnancy-Induced, run by Medical College of Wisconsin at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The long-term goal of our work is to evaluate the effect of intensive postpartum blood pressure control on maternal cardiovascular health, risk of chronic hypertension, and reversal of vascular dysfunction generated by hypertensive disorders of pregnancy, thus attenuating the lifelong trajectory of cardiovascular… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Hypertension, Pregnancy-Induced
What is being tested?
Nifedipine ER
Could I receive a placebo?
No, everyone receives an active treatment
How many people
618 participants
Where
2 sitesUnited States
Study dates
23 Oct 2024to 30 Jun 2029
Phase
Interventional
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

  • Hypertensive disorders of pregnancy (HDP) diagnosis, specifically gestational hypertension, preeclampsia, eclampsia, or HELLP syndrome, according to ACOG guidelines
  • Postpartum day 0-4
  • Age ≥ 18 years
  • Able to communicate in English or in Spanish
  • Has an established OBGYN at an MCW or NU health system practice that has access to Epic electronic medical records.

Who cannot join

  • Pre-gestational hypertension
  • Type 1 or type 2 diabetes mellitus
  • Admitted to intensive care unit at the time of screening
  • Diagnosed with HDP during postpartum readmission after discharge from delivery hospitalization
  • Getting discharged on the day of screening
  • Known allergy or contraindication to nifedipine ER
Show all 9Show fewer
  • Inability or unwillingness to provide informed consent
  • Already taking long-acting antihypertensive medication for standard care
  • Maternal conditions that impact study outcomes: sickle cell disease, systemic lupus erythematosus

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Alyssa M Hernandez, DO contact

4148055285

alyhernandez@mcw.edu

Amandla Stanley, MSN contact

4148056691

akstanley@mcw.edu

United States2 sites, 2 recruiting
  • Northwestern University

    Chicago, Illinois, 60611

    Lynn Yee, MD, lynn.yee@northwestern.edu

    Lynn Yee, MD

    Recruiting
  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    Alyssa M Hernandez, DO, 4148055285, alyhernandez@mcw.edu

    Amandla Stanley, MSN, 4148056691, akstanley@mcw.edu

    Recruiting

Other trials in United States

About this study

The long-term goal of our work is to evaluate the effect of intensive postpartum blood pressure control on maternal cardiovascular health, risk of chronic hypertension, and reversal of vascular dysfunction generated by hypertensive disorders of pregnancy, thus attenuating the lifelong trajectory of cardiovascular disease risk.

Read the detailed description

The REPAIR trial is a multicenter randomized controlled trial of 618 postpartum patients with hypertensive disorders of pregnancy randomized to intensive blood pressure control versus usual care during the first 6 weeks postpartum. The intervention group will receive intensive blood pressure (BP) control with nifedipine extended-release initiation when BP is ≥ 140/90 mmHg. The active control group will receive usual care with nifedipine ER initiation when BP is ≥ 150/100. The study will take place at two clinical sites: Medical College of Wisconsin (MCW) and Northwestern University (NU). All participants will undergo BP monitoring, cardiovascular function assessment, and collection of cardiovascular biomarkers at baseline, 6 weeks, and 12 months postpartum. Specifically, cardiac function and structure will be assessed with transthoracic echocardiogram, endothelial dysfunction with brachial artery flow-mediated dilation, and arterial stiffness with carotid-femoral pulse wave velocity. The primary outcome is the incident diagnosis of stage I hypertension at one year postpartum.

Being tested
Nifedipine ER
Medical subject headings
Hypertension, Pregnancy-Induced

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nifedipine ERDrug

    Also called Procardia XL, Adalat XL

    Initiation of nifedipine ER postpartum at randomly assigned threshold during the first 6 weeks postpartum.

Study groups in NCT06220721
Study groupRoleWhat they receive
REPAIR ARMExperimentalIntensive 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.
Receives: Drug: Nifedipine ER
CONTROL ARMActive comparatorUsual 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.
Receives: Drug: Nifedipine ER

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Chronic hypertension

    Diagnosis of chronic hypertension, defined as stage I hypertension with BP >130/80 mmHg

    Measured: One year postpartum

Secondary outcomes (8)
  1. Endothelial dysfunction

    Brachial artery flow-mediated dilation will assess endothelial dysfunction.

    Measured: One year postpartum

  2. Arterial stiffness

    Carotid-femoral pulse wave velocity will assess arterial stiffness.

    Measured: One year postpartum

  3. Cardiac structure and function

    Transthoracic echocardiogram will assess cardiac structure and function.

    Measured: One year postpartum

  4. Unplanned healthcare utilization

    Unplanned hospital readmissions, emergency department visits, and clinic visits.

    Measured: After birth through one year postpartum

  5. Composite severe maternal morbidity

    Maternal core outcomes of preeclampsia using PMID: 32674052 reference.

    Measured: After birth through one year postpartum

  6. Life's Essential 8 cardiovascular health score

    The score (0-100) will be calculated using American Heart Association application.

    Measured: After birth through one year postpartum

  7. Severe postpartum hypertension

    Blood pressure >160/110 mmHg

    Measured: After birth through one year postpartum

  8. ASCVD score

    Lifetime risk calculated for subjects >20 years and 10-year risk calculated for subjects > 40 years.

    Measured: One year postpartum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2024
  2. Study start23 Oct 2024
  3. Primary completion31 Mar 2029 (estimated)
  4. Study completion30 Jun 2029 (estimated)

Resources

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 N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel Assignment
Masking
None (open label)
Enrolment
618 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06220721
Sponsor's protocol ID
PRO00049909
Other IDs
1R01HD112930-01A1
Acronym
REPAIR
Status last verified
Jul 2026
First submitted
15 Jan 2024
Last updated
20 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: After study closure, data will be deidentified, archived, and transmitted to the NICHD Data Specimen and Hub (DASH). Permission to transmit and store the data in DASH is included in the informed consent document.

Publications

  • Duffy JMN, Cairns AE, Magee LA, von Dadelszen P, van 't Hooft J, Gale C, Brown M, Chappell LC, Grobman WA, Fitzpatrick R, Karumanchi SA, Lucas DN, Mol B, Stark M, Thangaratinam S, Wilson MJ, Williamson PR, Ziebland S, McManus RJ; International Collaboration to Harmonise Outcomes for Pre-eclampsia (iHOPE). Standardising definitions for the pre-eclampsia core outcome set: A consensus development study. Pregnancy Hypertens. 2020 Jul;21:208-217. doi: 10.1016/j.preghy.2020.06.005. Epub 2020 Jun 20.

    PubMed 32674052
  • Too G, Wen T, Boehme AK, Miller EC, Leffert LR, Attenello FJ, Mack WJ, D'Alton ME, Friedman AM. Timing and Risk Factors of Postpartum Stroke. Obstet Gynecol. 2018 Jan;131(1):70-78. doi: 10.1097/AOG.0000000000002372.

    PubMed 29215510
  • Wu P, Haththotuwa R, Kwok CS, Babu A, Kotronias RA, Rushton C, Zaman A, Fryer AA, Kadam U, Chew-Graham CA, Mamas MA. Preeclampsia and Future Cardiovascular Health: A Systematic Review and Meta-Analysis. Circ Cardiovasc Qual Outcomes. 2017 Feb;10(2):e003497. doi: 10.1161/CIRCOUTCOMES.116.003497. Epub 2017 Feb 22.

    PubMed 28228456
  • Parikh NI, Gonzalez JM, Anderson CAM, Judd SE, Rexrode KM, Hlatky MA, Gunderson EP, Stuart JJ, Vaidya D; American Heart Association Council on Epidemiology and Prevention; Council on Arteriosclerosis, Thrombosis and Vascular Biology; Council on Cardiovascular and Stroke Nursing; and the Stroke Council. Adverse Pregnancy Outcomes and Cardiovascular Disease Risk: Unique Opportunities for Cardiovascular Disease Prevention in Women: A Scientific Statement From the American Heart Association. Circulation. 2021 May 4;143(18):e902-e916. doi: 10.1161/CIR.0000000000000961. Epub 2021 Mar 29.

    PubMed 33779213
  • Hauspurg A, Lemon L, Cabrera C, Javaid A, Binstock A, Quinn B, Larkin J, Watson AR, Beigi RH, Simhan H. Racial Differences in Postpartum Blood Pressure Trajectories Among Women After a Hypertensive Disorder of Pregnancy. JAMA Netw Open. 2020 Dec 1;3(12):e2030815. doi: 10.1001/jamanetworkopen.2020.30815.

    PubMed 33351087
  • Shahul S, Tung A, Minhaj M, Nizamuddin J, Wenger J, Mahmood E, Mueller A, Shaefi S, Scavone B, Kociol RD, Talmor D, Rana S. Racial Disparities in Comorbidities, Complications, and Maternal and Fetal Outcomes in Women With Preeclampsia/eclampsia. Hypertens Pregnancy. 2015 Nov;34(4):506-515. doi: 10.3109/10641955.2015.1090581. Epub 2015 Dec 4.

    PubMed 26636247
  • Levine L, Arany Z, Kern-Goldberger A, Koelper N, Lewey J, Sammel MD, Elovitz MA, Ky B. Soluble Flt1 levels are associated with cardiac dysfunction in Black women with and without severe preeclampsia. Hypertens Pregnancy. 2021 Feb;40(1):44-49. doi: 10.1080/10641955.2020.1861462. Epub 2020 Dec 20.

    PubMed 33345653
  • Grand'Maison S, Pilote L, Okano M, Landry T, Dayan N. Markers of Vascular Dysfunction After Hypertensive Disorders of Pregnancy: A Systematic Review and Meta-Analysis. Hypertension. 2016 Dec;68(6):1447-1458. doi: 10.1161/HYPERTENSIONAHA.116.07907. Epub 2016 Oct 17.

    PubMed 27754864
  • Lane-Cordova AD, Khan SS, Grobman WA, Greenland P, Shah SJ. Long-Term Cardiovascular Risks Associated With Adverse Pregnancy Outcomes: JACC Review Topic of the Week. J Am Coll Cardiol. 2019 Apr 30;73(16):2106-2116. doi: 10.1016/j.jacc.2018.12.092.

    PubMed 31023435
  • Weissgerber TL, Milic NM, Milin-Lazovic JS, Garovic VD. Impaired Flow-Mediated Dilation Before, During, and After Preeclampsia: A Systematic Review and Meta-Analysis. Hypertension. 2016 Feb;67(2):415-23. doi: 10.1161/HYPERTENSIONAHA.115.06554. Epub 2015 Dec 28.

    PubMed 26711737
  • Hirshberg A, Downes K, Srinivas S. Comparing standard office-based follow-up with text-based remote monitoring in the management of postpartum hypertension: a randomised clinical trial. BMJ Qual Saf. 2018 Nov;27(11):871-877. doi: 10.1136/bmjqs-2018-007837. Epub 2018 Apr 27.

    PubMed 29703800
  • Lopes Perdigao J, Hirshberg A, Koelper N, Srinivas SK, Sammel MD, Levine LD. Postpartum blood pressure trends are impacted by race and BMI. Pregnancy Hypertens. 2020 Apr;20:14-18. doi: 10.1016/j.preghy.2020.02.006. Epub 2020 Feb 26.

    PubMed 32143061
  • Stuart JJ, Tanz LJ, Rimm EB, Spiegelman D, Missmer SA, Mukamal KJ, Rexrode KM, Rich-Edwards JW. Cardiovascular Risk Factors Mediate the Long-Term Maternal Risk Associated With Hypertensive Disorders of Pregnancy. J Am Coll Cardiol. 2022 May 17;79(19):1901-1913. doi: 10.1016/j.jacc.2022.03.335.

    PubMed 35550687
  • Whelton PK, Carey RM, Aronow WS, Casey DE Jr, Collins KJ, Dennison Himmelfarb C, DePalma SM, Gidding S, Jamerson KA, Jones DW, MacLaughlin EJ, Muntner P, Ovbiagele B, Smith SC Jr, Spencer CC, Stafford RS, Taler SJ, Thomas RJ, Williams KA Sr, Williamson JD, Wright JT Jr. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2018 May 15;71(19):e127-e248. doi: 10.1016/j.jacc.2017.11.006. Epub 2017 Nov 13. No abstract available.

    PubMed 29146535
  • Lloyd-Jones DM, Allen NB, Anderson CAM, Black T, Brewer LC, Foraker RE, Grandner MA, Lavretsky H, Perak AM, Sharma G, Rosamond W; American Heart Association. Life's Essential 8: Updating and Enhancing the American Heart Association's Construct of Cardiovascular Health: A Presidential Advisory From the American Heart Association. Circulation. 2022 Aug 2;146(5):e18-e43. doi: 10.1161/CIR.0000000000001078. Epub 2022 Jun 29.

    PubMed 35766027

Questions about this trial

What is this clinical trial studying?

A study testing Nifedipine ER in people with Hypertension, Pregnancy-Induced, run by Medical College of Wisconsin at 2 sites 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 5 inclusion and 9 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 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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.

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 Alyssa M Hernandez, DO (4148055285, alyhernandez@mcw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Chronic hypertension (time frame: One year postpartum). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06220721, which also lists 15 linked publications.

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 20 Jul 2026.

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