Continuation of the nuMoM2b Heart Health Study

NCT05472597 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 4048

Last updated 2025-10-21

No results posted yet for this study

Summary

Cardiovascular disease (CVD) is the leading cause of mortality and morbidity in U.S. women at all ages, and large knowledge gaps exist in CVD predictive and preventative strategies for women. The nuMoM2b Heart Health Study (nuMoM2b-HHS) has followed a demographically diverse cohort of women enrolled and richly phenotyped during their first pregnancy, with data and biospecimens prospectively collected for up to 7 years thereafter. The overarching scientific goal of this study is to define the relationship between adverse pregnancy outcomes (APOs) and CVD to optimize CVD prediction, prevention, and treatment strategies for women. Continued follow-up of this observational cohort, building on a foundation of existing high-quality data, biospecimens, and administrative structures with a robust framework for ancillary study development and implementation, provides a unique opportunity to address knowledge gaps regarding the early mechanisms and trajectory of CVD in women.

Conditions

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH
  • Northwestern University

    collaborator OTHER
  • Ohio State University

    collaborator OTHER
  • Cedars-Sinai Medical Center

    collaborator OTHER
  • Case Western Reserve University

    collaborator OTHER
  • Columbia University

    collaborator OTHER
  • ChristianaCare

    collaborator OTHER
  • Indiana University

    collaborator OTHER
  • University of Pittsburgh

    collaborator OTHER
  • University of California, Irvine

    collaborator OTHER
  • University of Utah

    collaborator OTHER
  • University of Pennsylvania

    collaborator OTHER
  • Intermountain Health Care, Inc.

    collaborator OTHER
  • University of Michigan

    collaborator OTHER
  • West Virginia University

    collaborator OTHER
  • Old Dominion University

    collaborator OTHER
  • RTI International

    lead OTHER

Principal Investigators

  • George Saade, MD · Old Dominion University

  • Phillip Greenland, MD · Northwestern University

  • Rebecca McNeil, PhD · RTI International

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-29
Primary Completion
2027-01-31
Completion
2027-01-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05472597 on ClinicalTrials.gov