NCT04828070

Brief Summary

Prospective US registry of pregnant women with cardiac disease to address the substantial gaps in knowledge surrounding these patients, in order to improve future care.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
2mo left

Started Dec 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Dec 2020Jun 2026

Study Start

First participant enrolled

December 1, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 2, 2020

Completed
4 months until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2024

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

October 24, 2025

Status Verified

October 1, 2025

Enrollment Period

3.2 years

First QC Date

December 2, 2020

Last Update Submit

October 22, 2025

Conditions

Pregnancy RelatedCardiac Disease

Keywords

Cardio-obstetricsHOPE RegistryCardiac disease in pregnancyHeart disease in pregnancyMarch of Dimes

Outcome Measures

Primary Outcomes (5)

  • Descriptive outcome: Outcomes

    Assess the maternal, neonatal and fetal outcomes of pregnancies affected by maternal cardiac disease

    5 years

  • Descriptive outcome: morbidity and mortality

    Assess the maternal, fetal and neonatal morbidity and mortality associated with a pregnancy that is complicated by both congenital and acquired heart disease (see inclusion criteria for these definitions) through 5 years postpartum

    5 years

  • Descriptive outcome: quality of life parameters

    Assess quality of life parameters during both gestation and the postpartum period in women with heart disease during pregnancy

    1 year

  • Descriptive outcome: racial differences in maternal-fetal outcomes

    Describe racial differences in maternal - fetal outcomes

    5 years

  • Descriptive outcome: outcomes and care pattern changes as a result of the COVID pandemic

    Assess the outcomes and care pattern changes as a result of the COVID pandemic for women with heart disease in pregnancy

    5 years

Study Arms (1)

Registry participant

Prospective collection of clinical information, completion of anxiety/depression, microaggressions, and quality of life questionnaires

Other: Observation

Interventions

ObservationOTHER

all participants followed for clinical data for one year, vital status check at 5 years

Registry participant

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women with cardiovascular disease

You may qualify if:

  • Aged 18 and older
  • 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

You may not qualify if:

  • Unable to provide written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States

Location

Related Publications (12)

  • Centers for Disease Control and Prevention. Pregnancy Mortality Surveillance System 2014. http://www.cdc.gov/reproductivehealth/maternalinfanthealth/pmss.htm

    BACKGROUND

  • www.Americanhealthrankings.org/explore/health-of-women-and-children/meaure/maternal_mortality/state/MO

    BACKGROUND

  • 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.

    PMID: 23500328BACKGROUND

  • 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.

    PMID: 11479246BACKGROUND

  • 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.

    PMID: 16534011BACKGROUND

  • 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.

    PMID: 16449731BACKGROUND

  • 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.

    PMID: 20584777BACKGROUND

  • 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.

    PMID: 19411123BACKGROUND

  • 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.

    PMID: 30877505BACKGROUND

  • 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.

    PMID: 30873658BACKGROUND

  • 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.

    PMID: 30208484BACKGROUND

  • 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.

    PMID: 30278179BACKGROUND

MeSH Terms

Conditions

Heart Diseases

Interventions

Observation

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Anna Grodzinsky, MD

    Saint Luke's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2020

First Posted

April 1, 2021

Study Start

December 1, 2020

Primary Completion

February 29, 2024

Study Completion (Estimated)

June 30, 2026

Last Updated

October 24, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)