The Heart Outcomes in Pregnancy Expectations (H.O.P.E) Registry

Last updated: May 23, 2024
Sponsor: Saint Luke's Health System
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Cardiac Disease

Treatment

Observation

Clinical Study ID

NCT04828070
HOPE Pilot Registry
  • Ages 18-55
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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

Exclusion

Exclusion Criteria:

  • Unable to provide written informed consent

Study Design

Total Participants: 75
Treatment Group(s): 1
Primary Treatment: Observation
Phase:
Study Start date:
December 01, 2020
Estimated Completion Date:
June 30, 2026

Study Description

The maternal mortality rate in the United States continues to climb, with cardiovascular disease as the leading cause for death in and around pregnancy. The racial disparities in the United States are also concerning as African American women have a 4-fold higher risk as compared to their Caucasian, Asian, or Hispanic counterparts. A Review To Action report, a collaboration of nine states' maternal mortality review committees, published in July 2018 determined that 63% of these deaths were preventable. Most deaths were related to clinical, facility and system factors, including missed or delayed diagnosis, inefficient response to obstetrical emergencies and poor communication and coordination between team members. Understanding these trends on a national level is imperative if any notable change is to be made. This requires filling the knowledge gaps that currently exist, which can be accomplished by a national registry.

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.

Connect with a study center

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri 64111
    United States

    Site Not Available

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