Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)

NCT06280820 | Enrolling By Invitation

• 2 other identifiers: 10001889001889-H
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

Background: More than 6.5 million people in the United States live with heart failure (HF), and more than a million new cases are diagnosed each year. Treatments have improved in recent years, but researchers want to understand more about how HF develops. To do this, they need to compare blood and other samples from many people with HF. Objective: To collect blood and other samples from people with HF. These samples will be used to identify and study proteins and other factors that may lead to decreased heart function over time. Eligibility: People aged 18 years and older with heart failure. Design: Participants will be asked to join the study based on a review of their medical records. They will have 1 study visit. They will provide a blood sample: About 3 tablespoons will be collected from a needle inserted into a vein. Other tests are optional: Participants may provide urine and stool samples. They may have a cotton swab rubbed on the inside of the mouth to collect DNA. Participants may also take 3 questionnaires. They will answer questions about dietary, social, and other factors that affect their health. Participants will receive compensation. Researchers will follow the participants health by monitoring their medical records for up to 5 years.

Conditions

Heart Failure

Keywords

Heart Failure; Proteolytic; Metabolomics; Social determinant of health

Outcome Measures

Primary Outcomes (1)

• To study the association between multi-omics signatures with all-cause mortality

  The heterogeneous HF syndrome encompasses different and poorly defined entities. Multi-omics can improve its characterization and the prediction of mortality, which remains high. All-cause mortality will be analyzed as the time from enrollment to all-cause death.

  10 years

Secondary Outcomes (2)

• Clinical phenotypes defined by:Ejection Fraction (>=50 vs. < 50)NYHA (3-4 vs. 1-2)

  >=18 months vs. < 18 months

• To study the cross-sectional association between multi-omics signatures with clinical sub-phenotypes of heart failure

  5 years

Study Arms (1)

Participants with heart condition

Heart Failure

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

We will prospectively recruit a community cohort of 2000 participants with clinical HF from the District of Columbia / Maryland/Virginia metropolitan region (DMV).

You may qualify if:

• In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• Clinical diagnosis of "active" HF documented by a cardiology provider's note in the medical record. Active HF is the presence of signs or symptoms that are deemed to be related to heart failure, as documented in the participants' medical records.
• Able and willing to undergo the consent process and provide consent
• Willing to comply with required study activities
• years of age or older

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in this study:
• History of ventricular assist device
• History of cardiac transplant
• Living or residing outside of the geographic location designated for the study at the time of enrollment

Sponsors & Collaborators

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

Study Sites (1)

INOVA Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Veronique L Roger, M.D.

  National Heart, Lung, and Blood Institute (NHLBI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2024
• First Posted: February 28, 2024
• Study Start (Estimated): April 21, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2034
• Last Updated: April 16, 2026

Record last verified: 2025-12-30

Locations

US (1)