Evaluating heart health outcomes in pregnant individuals with heart disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the obstetrical, neonatal, and cardiovascular outcomes of 1000 pregnant individuals with known heart disease. It seeks to identify optimal structures for cardio-obstetrics care to improve maternal and neonatal health outcomes. The study addresses the rising maternal mortality rates in the U.S., particularly among marginalized populations, by focusing on the significant impact of cardiovascular disease during pregnancy. By collecting prospective data, the study aims to uncover factors contributing to maternal morbidity and mortality, especially in communities disproportionately affected by these issues.

Why it matters

Who can join: the full rules

Inclusion:

Must have one or more condition(s) within the 6 following categories - Repaired or Unrepaired

* Congenital or structural heart disease
* Aortopathies
* Arrhythmias
* Cardiomyopathies and Heart Failure
* Coronary disease
* Other (Current endocarditis or history of endocarditis, Pericarditis, Pericardial effusion - Moderate or Large, Pericardial constriction, Pulmonary hypertension (all types) defined as mean pulmonary artery systolic pressure of \>20 mmHg by right heart catheterization or pulmonary hypertension estimated in the severe range by echo)

Exclusion Criteria

* Unable to participate in telephone follow-up
* Too hard of hearing to do follow-up by telephone or deaf
* Incarcerated prisoner
* History of dementia.
* Subjects without a way for contact by telephone for follow-up
* Refused participation in the study
* Unable to consent for self
* Traumatic Aortic Disease
* Peripartum cardiomyopathy diagnosed in current pregnancy

Where it's running

• Saint Luke's Hospital of Kansas City
  Kansas City, Missouri, United States Recruiting

Study contacts

• Principal investigator: John Spertus, MD, MPH — University of Missouri, Kansas City
• Study coordinator: Karen L Florio, DO, MPH
• Email: klwa42@umsystem.edu
• Phone: 631-579-1030

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.