Status:
ACTIVE_NOT_RECRUITING
The Heart Outcomes in Pregnancy Expectations (H.O.P.E) Registry
Lead Sponsor:
Saint Luke's Health System
Collaborating Sponsors:
Massachusetts General Hospital
Conditions:
Pregnancy Related
Cardiac Disease
Eligibility:
FEMALE
18-55 years
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...
Eligibility Criteria
Inclusion
- 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
- Unable to provide written informed consent
Key Trial Info
Start Date :
December 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT04828070
Start Date
December 1 2020
End Date
June 30 2026
Last Update
October 24 2025
Active Locations (1)
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1
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States, 64111