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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HD112930-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nifedipine ER | Drug | Initiation of nifedipine ER postpartum at randomly assigned threshold during the first 6 weeks postpartum. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Chronic hypertension | Diagnosis of chronic hypertension, defined as stage I hypertension with BP >130/80 mmHg | One year postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Endothelial dysfunction | Brachial artery flow-mediated dilation will assess endothelial dysfunction. | One year postpartum |
| Arterial stiffness | Carotid-femoral pulse wave velocity will assess arterial stiffness. |
| Measure | Description | Time Frame |
|---|---|---|
| Serum biomarkers of cardiovascular risk | Soluble fms-like tyrosine kinase (sFlt-1), Lipoprotein (a), TNF-alpha, IL-6, NT-proBNP, CRP, high-sensitivity troponin | One year postpartum |
| Breastfeeding initiation and duration |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alyssa M Hernandez, DO | Contact | 4148055285 | alyhernandez@mcw.edu | |
| Amandla Stanley, MSN | Contact | 4148056691 | akstanley@mcw.edu |
| Name | Affiliation | Role |
|---|---|---|
| Anna Palatnik, MD | Medical College of Wisconsin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Recruiting | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32674052 | Background | 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. | |
| 29215510 |
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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.
Anticipated 6/30/2030
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.
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| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D006973 | Hypertension |
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| ID | Term |
|---|---|
| D009543 | Nifedipine |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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Parallel Assignment
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|
| One year postpartum |
| Cardiac structure and function | Transthoracic echocardiogram will assess cardiac structure and function. | One year postpartum |
| Unplanned healthcare utilization | Unplanned hospital readmissions, emergency department visits, and clinic visits. | After birth through one year postpartum |
| Composite severe maternal morbidity | Maternal core outcomes of preeclampsia using PMID: 32674052 reference. | After birth through one year postpartum |
| Life's Essential 8 cardiovascular health score | The score (0-100) will be calculated using American Heart Association application. | After birth through one year postpartum |
| Severe postpartum hypertension | Blood pressure >160/110 mmHg | After birth through one year postpartum |
| ASCVD score | Lifetime risk calculated for subjects >20 years and 10-year risk calculated for subjects > 40 years. | One year postpartum |
Assessed with Infant Feeding Practices Postnatal Questionnaires
| After birth through one year postpartum |
| Medical College of Wisconsin | Recruiting | Milwaukee | Wisconsin | 53226 | United States |
|
| 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. |
| 28228456 | 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. |
| 33779213 | 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. |
| 33351087 | 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. |
| 26636247 | 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. |
| 33345653 | 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. |
| 27754864 | 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. |
| 31023435 | 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. |
| 26711737 | 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. |
| 29703800 | 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. |
| 32143061 | 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. |
| 35550687 | 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. |
| 29146535 | 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. |
| 35766027 | 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. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |