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

NCT06220721 | Recruiting DMC

• 2 other identifiers: PRO000499091R01HD112930-01A1
• Study Type: interventional
• Target: 618
• Locations: 1 country
• Sites: 2

Brief 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 disease risk.

Conditions

Hypertension, Pregnancy-Induced

Outcome Measures

Primary Outcomes (1)

• Chronic hypertension

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

  One year postpartum

Secondary Outcomes (8)

• Endothelial dysfunction

  One year postpartum

• Arterial stiffness

  One year postpartum

• Cardiac structure and function

  One year postpartum

• Unplanned healthcare utilization

  After birth through one year postpartum

• Composite severe maternal morbidity

  After birth through one year postpartum

Other Outcomes (2)

• Serum biomarkers of cardiovascular risk

  One year postpartum

• Breastfeeding initiation and duration

  After birth through one year postpartum

Study Arms (2)

REPAIR ARM

EXPERIMENTAL

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.

Drug: Nifedipine ER

CONTROL ARM

ACTIVE COMPARATOR

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.

Drug: Nifedipine ER

Interventions

Nifedipine ER DRUG

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

Also known as: Procardia XL, Adalat XL

CONTROL ARM; REPAIR ARM

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (2)

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Related Publications (15)

• 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.

  PMID: 32674052 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 33779213 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 31023435 BACKGROUND

• 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.

  PMID: 26711737 BACKGROUND

• 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.

  PMID: 29703800 BACKGROUND

• 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.

  PMID: 32143061 BACKGROUND

• 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.

  PMID: 35550687 BACKGROUND

• 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.

  PMID: 29146535 BACKGROUND

• 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.

  PMID: 35766027 BACKGROUND

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced

Interventions

Nifedipine

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Anna Palatnik, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alyssa M Hernandez, DO

CONTACT

4148055285; alyhernandez@mcw.edu

Amandla Stanley, MSN

CONTACT

4148056691; akstanley@mcw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: January 15, 2024
• First Posted: January 24, 2024
• Study Start: October 23, 2024
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): June 30, 2029
• Last Updated: May 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Anticipated 6/30/2030
• Access Criteria: The NICHD DASH Data Access Committee reviews all requests to access DASH data and biospecimens from identity-verified requesters to determine whether the proposed use is scientifically and ethically appropriate and does not conflict with constraints or research data use limitations identified by the institutions that submitted the research data or biospecimens.

Locations

US (2)