Heart Failure Clinical Trial

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

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. They may also answer questions about their health, heart treatments, and related topics.

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. They may have a test of their heart function: Small stickers attached to wires will be placed on their chest, arms, and legs; these will record the electricity generated as the heart beats.

Participants may also take 3 questionnaires. They will answer questions about dietary, social, and other factors that affect their health.

Researchers will follow the participants health by monitoring their medical records for up to 5 years.

View Full Description

Full Description

Study Description:

Our general hypothesis is that clinical and molecular data will generate new mechanistic knowledge and transform our understanding of the heterogeneous forms of heart failure (HF) syndrome. To do so, we will create a data-rich ecosystem by building a diverse population-based registry. By grounding our work in the community within the District of Columbia / Maryland/Virginia metropolitan region (DMV) with deliberate intent on recruiting diverse participants from diverse populations, we will optimize inference and facilitate community translation. We will prospectively recruit a diverse community cohort of 2000 participants with clinical HF from the DMV area and collect biospecimens (blood, urine, stool, and buccal specimens) to measure multi-omics (specifically proteomics, metabolomics)signatures. We will integrate the results of the multi-omics assays to electronic medical records (EMR)-driven phenotypic representation (e.g. symptoms at clinical presentation, comorbid conditions, frailty, imaging data, ejection fraction, and laboratory values) collected during clinical care. Patients records will be followed for up to 5 years after recruitment to monitor key characteristics and events including death.

Objectives:

Primary Objective:

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

Secondary Objectives:

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

Exploratory Objectives:

To study the association between multi-omics signatures with HFrelated hospitalizations.
To study the cross-sectional association between multi-omics signatures and HF sub-phenotypes based on clinical biomarkers across the spectrum of heart failure.
To investigate the relationship between multi-omics signatures and findings (may include clinical or research data), and advanced imaging data used in clinical characterization and phenotyping of heart failure and its various underlying etiologies
To explore both germline (i.e., inherited) and somatic (i.e., de novo or acquired) genetic variants contributing to HF sub phenotypes.
To explore epigenetic and gene expression alterations contributing to HF sub phenotypes.

Endpoints:

Primary Endpoint will be all-cause mortality.

Secondary Endpoints will be:

Cardiovascular mortality
Clinical sub-phenotypes of heart failure are defined by the following:
Ejection Fraction, by echocardiogram (>=50% vs. < 50%)
Severity measured by New York Heart Association class (3-4 vs. 1-2)
HF duration (>=18 months vs. < 18 months)
Etiology (Ischemic vs. Non-Ischemic)
Comorbidity - diabetes, hypertension, chronic obstructive pulmonary disease, atrial fibrillation, cerebrovascular disease, body mass index (>=30 vs. < 30), age (median cut)

Exploratory Endpoints will be:

HF-related hospitalization
Biomarkers related to HF including N-terminal pro-brain natriuretic peptide (NT-proBNP), Cystatin C, Neutrophil gelatinase-associated lipocalin (NGAL), Galectin-3, soluble interleukin 1 1 (ST2), Troponin T, I, or C, Vascular cell adhesion protein 1 (VCAM-one), ICAM, E-selectin, CRP, TNF- alpha, interleukins, cortisol, and/or adiponectin
Genomic analyses including whole exome or whole genome sequencing (WGS) to determine pathways, genes, genetic variants, and structural changes to DNA that may be related to HF syndrome.
Epigenetic analyses including DNA methylation measurements to characterize differentially methylated sites that may be related to HF syndrome.
Transcriptomic analyses to characterize alterations to gene expression that may be related to HF syndrome.

View Eligibility Criteria

Eligibility Criteria

INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

Clinical diagnosis of HF documented by a provider s note in the medical record
Able and willing to undergo the consent process and provide consent
Willing to comply with required study activities
18 years of age or older
Male or female (or other gender-specified category)

EXCLUSION CRITERIA:

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

Study is for people with:

Heart Failure

Estimated Enrollment:

2000

Study ID:

NCT06280820

Recruitment Status:

Not yet recruiting

Sponsor:

National Heart, Lung, and Blood Institute (NHLBI)

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There is 1 Location for this study

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National Heart, Lung and Blood Institute (NHLBI)
Bethesda Maryland, 20892, United States More Info
Veronique Roger, M.D.
Contact
301-402-1715
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

2000

Study ID:

NCT06280820

Recruitment Status:

Not yet recruiting

Sponsor:


National Heart, Lung, and Blood Institute (NHLBI)

How clear is this clinincal trial information?

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