The Heart Outcomes in Pregnancy Expectations (H.O.P.E) Registry
NCT ID: NCT04828070
Last Updated: 2025-10-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
75 participants
OBSERVATIONAL
2020-12-01
2026-06-30
Brief Summary
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Detailed Description
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Marked improvements in treating congenital heart disease have led to more women with repaired congenital cardiac malformations reaching reproductive age and desiring fertility. Beyond the growth in the prevalence of congenital heart disease, acquired cardiac disease-peripartum cardiomyopathy, ischemic heart disease, aortic dissection- are increasing and are associated with the highest risk of maternal mortality. This is particularly notable in the United States as compared to other countries where the rates of obesity and metabolic disorders approach one-third of the adult population. Adding to the complexity of the American demographics is the growing birthrate in women over 35 years of age. These trends mandate a reconceptualization of maternity care to recognize the changing demographics of pregnancy in the United States and how the growing prevalence of cardiac disease complicates care.
Other countries, particularly in Europe, have begun to investigate these issues, and as a result, their maternal mortality rates are far better than the US. Part of the European decline can be attributed to their robust prospective databases that assess pregnancy throughout the antepartum and postpartum time frame. It is becoming the dominant source of data in the medical literature describing the outcomes of patients with cardiac disease in pregnancy, yet there is no such equivalent in the United States. Investigators have yet to define the risks of pregnancy on both congenital and acquired disease states, a critical knowledge gap that could be answered with a prospective, observational registry of women with heart disease. The investigators propose to lead a prospective US registry of pregnant women with cardiac disease to address the substantial gaps in knowledge surrounding the baseline, clinical characteristics, and long-term maternal-fetal outcomes.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Registry participant
Prospective collection of clinical information, completion of anxiety/depression, microaggressions, and quality of life questionnaires
Observation
all participants followed for clinical data for one year, vital status check at 5 years
Interventions
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Observation
all participants followed for clinical data for one year, vital status check at 5 years
Eligibility Criteria
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Inclusion Criteria
* Pregnant at any point in gestation (with singleton or multiple gestation)
* History of congenital and/or acquired heart disease defined as the following:
* valvular, congenital, ischemic heart disease or cardiomyopathy,
* clinically significant maternal arrhythmias in women,
* current or previous history of peripartum cardiomyopathy,
* supraventricular tachycardia,
* placement of either a pacemaker or electrical assist device,
* aortopathies (Marfan syndrome, Loey's Deitz, Ehlers Danlos \[vascular subtype\],
* pre-pregnancy diagnosis of pulmonary hypertension
* English- or Spanish-speaking
Exclusion Criteria
18 Years
55 Years
FEMALE
No
Sponsors
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Massachusetts General Hospital
OTHER
Saint Luke's Health System
OTHER
Responsible Party
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Principal Investigators
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Anna Grodzinsky, MD
Role: PRINCIPAL_INVESTIGATOR
Saint Luke's Hospital
Locations
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Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States
Countries
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References
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Centers for Disease Control and Prevention. Pregnancy Mortality Surveillance System 2014. http://www.cdc.gov/reproductivehealth/maternalinfanthealth/pmss.htm
www.Americanhealthrankings.org/explore/health-of-women-and-children/meaure/maternal_mortality/state/MO
Blecker S, Paul M, Taksler G, Ogedegbe G, Katz S. Heart failure-associated hospitalizations in the United States. J Am Coll Cardiol. 2013 Mar 26;61(12):1259-67. doi: 10.1016/j.jacc.2012.12.038.
Siu SC, Sermer M, Colman JM, Alvarez AN, Mercier LA, Morton BC, Kells CM, Bergin ML, Kiess MC, Marcotte F, Taylor DA, Gordon EP, Spears JC, Tam JW, Amankwah KS, Smallhorn JF, Farine D, Sorensen S; Cardiac Disease in Pregnancy (CARPREG) Investigators. Prospective multicenter study of pregnancy outcomes in women with heart disease. Circulation. 2001 Jul 31;104(5):515-21. doi: 10.1161/hc3001.093437.
James AH, Jamison MG, Biswas MS, Brancazio LR, Swamy GK, Myers ER. Acute myocardial infarction in pregnancy: a United States population-based study. Circulation. 2006 Mar 28;113(12):1564-71. doi: 10.1161/CIRCULATIONAHA.105.576751. Epub 2006 Mar 13.
Khairy P, Ouyang DW, Fernandes SM, Lee-Parritz A, Economy KE, Landzberg MJ. Pregnancy outcomes in women with congenital heart disease. Circulation. 2006 Jan 31;113(4):517-24. doi: 10.1161/CIRCULATIONAHA.105.589655.
Drenthen W, Boersma E, Balci A, Moons P, Roos-Hesselink JW, Mulder BJ, Vliegen HW, van Dijk AP, Voors AA, Yap SC, van Veldhuisen DJ, Pieper PG; ZAHARA Investigators. Predictors of pregnancy complications in women with congenital heart disease. Eur Heart J. 2010 Sep;31(17):2124-32. doi: 10.1093/eurheartj/ehq200. Epub 2010 Jun 28.
Ouyang DW, Khairy P, Fernandes SM, Landzberg MJ, Economy KE. Obstetric outcomes in pregnant women with congenital heart disease. Int J Cardiol. 2010 Oct 8;144(2):195-9. doi: 10.1016/j.ijcard.2009.04.006. Epub 2009 May 2.
Liese KL, Mogos M, Abboud S, Decocker K, Koch AR, Geller SE. Racial and Ethnic Disparities in Severe Maternal Morbidity in the United States. J Racial Ethn Health Disparities. 2019 Aug;6(4):790-798. doi: 10.1007/s40615-019-00577-w. Epub 2019 Mar 15.
Daymude AEC, Catalano A, Goodman D. Checking the pregnancy checkbox: Evaluation of a four-state quality assurance pilot. Birth. 2019 Dec;46(4):648-655. doi: 10.1111/birt.12425. Epub 2019 Mar 14.
Lu MC. Reducing Maternal Mortality in the United States. JAMA. 2018 Sep 25;320(12):1237-1238. doi: 10.1001/jama.2018.11652. No abstract available.
Wolfe DS, Hameed AB, Taub CC, Zaidi AN, Bortnick AE. Addressing maternal mortality: the pregnant cardiac patient. Am J Obstet Gynecol. 2019 Feb;220(2):167.e1-167.e8. doi: 10.1016/j.ajog.2018.09.035. Epub 2018 Sep 29.
Other Identifiers
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HOPE Pilot Registry
Identifier Type: -
Identifier Source: org_study_id
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