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Recruiting NCT06220721

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

No phase Interventional Hypertension, Pregnancy-Induced

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: Nifedipine ER.
Who it may be relevant to
Registry conditions: Hypertension, Pregnancy-Induced. 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 →

Unsure about the terms? Read our patient guide →

Overview

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.

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.

Interventions

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

Primary outcome measures

  • Chronic hypertension [Time frame: One year postpartum]
Secondary outcome measures (8)
  • Endothelial dysfunction [Time frame: One year postpartum]
  • Arterial stiffness [Time frame: One year postpartum]
  • Cardiac structure and function [Time frame: One year postpartum]
  • Unplanned healthcare utilization [Time frame: After birth through one year postpartum]
  • Composite severe maternal morbidity [Time frame: After birth through one year postpartum]
  • Life's Essential 8 cardiovascular health score [Time frame: After birth through one year postpartum]
  • Severe postpartum hypertension [Time frame: After birth through one year postpartum]
  • ASCVD score [Time frame: One year postpartum]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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
  • 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

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
Open label
Primary purpose
Prevention

Study locations

United States · 2 centers
  • Northwestern University — Chicago
  • Medical College of Wisconsin — Milwaukee

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 stu PMID 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. PMID 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. PMID 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 Cardiovascu PMID 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. PMID 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. PMID 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. PMID 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. PMID 27754864

Identifiers

NCT: NCT06220721 · PRO00049909 · 1R01HD112930-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗