Clinical trial NCT04828070: The Heart Outcomes in Pregnancy Expectations (H.O.P.E) Registry
Official title: The Heart Outcomes in Pregnancy Expectations (H.O.P.E) Registry Pilot
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pregnancy Related
Cardiac Disease
Keywords: Cardio-obstetrics
HOPE Registry
Cardiac disease in pregnancy
Heart disease in pregnancy
March of Dimes
Lead sponsor: Saint Luke's Health System
Sponsor class: OTHER
Collaborators: name: Massachusetts General Hospital
First posted: 2021-04-01
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women with cardiovascular disease

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.

Eligibility criteria: 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

Primary outcomes:
measure: Descriptive outcome: Outcomes
timeFrame: 5 years
measure: Descriptive outcome: morbidity and mortality
timeFrame: 5 years
measure: Descriptive outcome: quality of life parameters
timeFrame: 1 year
measure: Descriptive outcome: racial differences in maternal-fetal outcomes
timeFrame: 5 years
measure: Descriptive outcome: outcomes and care pattern changes as a result of the COVID pandemic
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Saint Luke's Hospital of Kansas City
state: Missouri
Study officials:
affiliation: Saint Luke's Hospital
name: Anna Grodzinsky, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Centers for Disease Control and Prevention. Pregnancy Mortality Surveillance System 2014. http://www.cdc.gov/reproductivehealth/maternalinfanthealth/pmss.htm
citation: www.Americanhealthrankings.org/explore/health-of-women-and-children/meaure/maternal_mortality/state/MO
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citation: 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.
citation: 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.
citation: 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.
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citation: 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.
citation: 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.