Heart Failure Clinical Trial
Official title:
Multi-Scale Phenotyping of Heart Failure in Diverse Populations: An Observational Population-Based Registry
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.
Status | Not yet recruiting |
Enrollment | 2000 |
Est. completion date | April 30, 2034 |
Est. primary completion date | April 30, 2028 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | - 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 |
Country | Name | City | State |
---|---|---|---|
United States | National Heart, Lung and Blood Institute (NHLBI) | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Heart, Lung, and Blood Institute (NHLBI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Clinical phenotypes defined by:Ejection Fraction (>=50 vs. < 50)NYHA (3-4 vs. 1-2) | Cardiovascular mortality is an important part of all-cause mortality and will be evaluated as a secondary outcome. Cardiovascular mortality will be analyzed as the time from enrollment to cardiovascular death | >=18 months vs. < 18 months | |
Secondary | To study the cross-sectional association between multi-omics signatures with clinical sub-phenotypes of heart failure | Clinical phenotypes defined by:Ejection Fraction (>=50 vs. < 50) NYHA (3-4 vs. 1-2)Duration of HF (>=18 months vs. < 18 months) Etiology (Ischemic vs. Non- Ischemic) Comorbidity - diabetes, hypertension, chronic | 5 years |
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