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

Active, not recruiting

• Conditions: Cardiac Disease; Pregnancy Related
• Interventions: Other: Observation

• Registration Number: NCT04828070
• Lead Sponsor: Saint Luke's Health System

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.

Detailed 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.

Study Timeline

• Study Start: 2020-12-01
• Study First Submitted: 2020-12-02
• Study First Submitted QC: 2021-03-30
• Study First Posted: 2021-04-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-23
• Last Update Posted: 2024-05-24
• Primary Completion: 2025-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 75

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 Criteria

• Unable to provide written informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Registry participant	Observation	Prospective collection of clinical information, completion of anxiety/depression, microaggressions, and quality of life questionnaires

Primary Outcome Measures

Name	Time	Method
Descriptive outcome: morbidity and mortality	5 years	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
Descriptive outcome: quality of life parameters	1 year	Assess quality of life parameters during both gestation and the postpartum period in women with heart disease during pregnancy
Descriptive outcome: racial differences in maternal-fetal outcomes	5 years	Describe racial differences in maternal - fetal outcomes
Descriptive outcome: Outcomes	5 years	Assess the maternal, neonatal and fetal outcomes of pregnancies affected by maternal cardiac disease
Descriptive outcome: outcomes and care pattern changes as a result of the COVID pandemic	5 years	Assess the outcomes and care pattern changes as a result of the COVID pandemic for women with heart disease in pregnancy

Trial Locations

Locations (1)

Saint Luke's Hospital of Kansas City; 🇺🇸 Kansas City, Missouri, United States