Continuation of the nuMoM2b Heart Health Study

Cardiovascular Diseases Clinical Trial

— nuMoM2b-HHS2  

Official title:

Continuation of the nuMoM2b Heart Health Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05472597
• Other study ID #: 00047665
• Secondary ID: U01HL145358
• Status: Enrolling by invitation
• Start date: November 29, 2022
• Est. completion date: January 2027

Study information

• Verified date: April 2024
• Source: RTI International
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The Continuation of nuMoM2b Heart Health Study (nuMoM2b-HHS2) will include prospectively collected longitudinal data on CVD risk factors and early clinical manifestations of CVD, the study's primary outcomes of interest. Measures completed during semiannual follow-ups will include 1) self-reported interval medical history, including medications and substance use; 2) interval pregnancy and postpartum history; 3) interval CVD events, conditions, and diagnostic and therapeutic procedures including CVD death, myocardial infarction (MI), stroke, transient ischemic attack (TIA), pulmonary embolism (PE), deep vein thrombosis (DVT), peripheral vascular disease, kidney disease, hypertension, diabetes, hyperlipidemia, and associated hospitalizations and procedures.

During a study visit in years 3-6, the participant's blood pressure, pulse rate, weight, height, and body measurements will be recorded. During the visit, a fasting blood draw and clean-catch urine specimen will be collected. Aliquots of whole blood, plasma, serum, and urine will be stored at the biorepository; these will be analyzed for CVD measures of lipids, triglycerides, and glucose, among others. Measures of behavioral risk factors, including nutrition, physical activity, and stress will also be completed.

Ancillary studies will expand data collection during the follow-up contacts and in-person visit, and add to the planned contact schedule, to permit the effective targeting of knowledge gaps required to optimize predictive and preventative strategies. Some ancillary studies will only rely on extant data, while others will require de novo data collection during the planned follow-up contacts and/or in-person visits (or participation in additional in-person visits).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 4048
• Est. completion date: January 2027
• Est. primary completion date: January 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria for nuMoM2b-HHS2 interval contact (telephone interview or web-based self-administered survey):

• Completed one or more interval contacts during the nuMoM2b Heart Health Study.

• Able to speak or read in English or Spanish.

Exclusion Criteria for nuMoM2b-HHS2 interval contact (telephone interview or web-based self-administered survey):

• Withdrawal from study.

Inclusion Criteria for nuMoM2b-HHS2 study visit:

• Completed one or more interval contacts during the nuMoM2b Heart Health Study.

• At least 18 years of age.

• Self-report of at least 3 months postpartum from any subsequent pregnancy.

• Provision of signed informed consent for the HHS2 study visit.

• Able to speak or read English or Spanish.

Exclusion Criteria for nuMoM2b-HHS2 study visit:

• Current pregnancy.

• Withdrawal from study.

Related Conditions & MeSH terms

• Cardiovascular Diseases

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois
United States	The MetroHealth System	Cleveland	Ohio
United States	Indiana University	Indianapolis	Indiana
United States	Intermountain Medical Center	Murray	Utah
United States	Columbia University Medical Center	New York	New York
United States	Christiana Care Health Services	Newark	Delaware
United States	McKay-Dee Hospital	Ogden	Utah
United States	University of California, Irvine Medical Center	Orange	California
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Pennsylvania Hospital	Philadelphia	Pennsylvania
United States	UPMC Magee Womens Hospital	Pittsburgh	Pennsylvania
United States	Utah Valley Hospital	Provo	Utah
United States	LDS Hospital	Salt Lake City	Utah
United States	University of Utah	Salt Lake City	Utah

Sponsors (17)

Lead Sponsor

Collaborator

RTI International

Case Western Reserve University, Cedars-Sinai Medical Center, ChristianaCare, Columbia University, Eastern Virginia Medical School, Indiana University, Intermountain Health Care, Inc., National Heart, Lung, and Blood Institute (NHLBI), Northwestern University, Ohio State University, University of California, Irvine, University of Michigan, University of Pennsylvania, University of Pittsburgh, University of Utah, West Virginia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of hypertension (130/80 mmHg)	Measured blood pressure > 130/80 mmHg, use of antihypertensive medication, or self-report of a hypertension clinical diagnosis	Assessed during the HHS2 in-person visit, 8-16 years after the index pregnancy.
Primary	Incidence of diabetes	Measured hemoglobin A1c GE 6.5%, fasting blood glucose GE 126 mg/dL, use of blood sugar lowering medication, or self-report of a diabetes clinical diagnosis	Assessed during the HHS2 in-person visit, 8-16 years after the index pregnancy.
Primary	Incidence of obesity	Measured BMI GE 30 kg/m^2	Assessed during the HHS2 in-person visit, 8-16 years after the index pregnancy.
Primary	Incidence of metabolic syndrome	Per the American Heart Association standard definition: Any three of the following five - 1) waist circumference > 35 inches (88 cm) for non-Asians and > 31.5 inches (80 cm) for Asians; 2) triglycerides > 150 mg/dL or medication treatment for high triglycerides; 3) high density lipoprotein (HDL) < 50 mg/dL or medication treatment for low HDL; 4) a serum glucose = 100 mg/dL or a diagnosis of diabetes mellitus; 5) systolic blood pressure (SBP) = 130 mmHg or diastolic blood pressure (DBP) = 85 mmHg, or medication treatment for hypertension.	Assessed during the HHS2 in-person visit, 8-16 years after the index pregnancy.