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EAGLE-HF: Understanding Heart Failure and Social Factors

This study, called EAGLE-HF, is looking at how social factors like race, social vulnerability, and marital status might be connected to developing new heart failure (HF). It's an observational study, meaning researchers will watch and collect information from 1000 participants who are already part of another study called SYMPHONY. You could be eligible if you are at least 40 years old, willing to sign a consent form, have certain activity levels (NYHA-FC score II-IV), and have at least two risk factors for heart failure, such as existing cardiovascular disease. The study aims to see if these social factors are linked to a new heart failure diagnosis over a 5-year period.

Study design
This is an observational study involving 1000 participants from a larger, multinational study called SYMPHONY. It is not specified if it is blinded or unblinded.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 5 years to assess new onset heart failure.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06849752

Early Assessment and Initiation of GuideLine-Directed Evidence-Based Management-HF

Recruiting
Not specifiedAges 40+Observational
The Cleveland Clinic
~1,000 participants
Updated 2026-05-08 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
New onset HF based on race
Measured over 5 years
+6 more outcomes measured

Conditions

Heart Failure
Socioeconomic Adversity

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Heart Failure

NCT06849752

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Cleveland Clinic

    Cleveland, Ohiostudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Nancy Albert, PhD · PRINCIPAL_INVESTIGATOR · The Cleveland Clinic

Who to contact

Nancy M Albert, PhD
[email protected]
2163129191
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

≥40 years old at enrollment
Willing to sign informed consent
Specific Activity Scale results that match a NYHA-FC score II-IV
Has a minimum of 2 documented risk factors for heart failure:
Established cardiovascular disease (e.g. persistent or permanent atrial fibrillation, myocardial infarction/ coronary artery disease \[coronary artery bypass grafting, percutaneous coronary intervention or documented stenosis or an epicardial coronary artery (50% LMS, \>70% LAD/Cx/RCA\], or valvular heart disease)
An established diagnosis of diabetes (type I or II)
Persistent or permanent atrial fibrillation (NOT paroxysmal atrial fibrillation)
Previous ischemic or embolic stroke
Peripheral arterial disease (previous surgical or percutaneous revascularisation or a documented stenosis \> 50% of a major peripheral arterial vessel).
Chronic kidney disease (defined as an estimated glomerular filtration rate \<60 mL/min/1.73m2 or eGFR 60-90 mL/min/1.73m2 and UACR \> 300 mg/g)
Loop diuretic use for \> 30 days (reported at any time in the 12 months prior to consent)
Chronic obstructive pulmonary disease (COPD; evidenced by one of the following; PFTs showing airway obstruction, diagnosis by respiratory physician, CT scan reporting presence of emphysema or treatment with national guideline advocated COPD therapy).

Exclusion

Inability to give informed consent; e.g., due to significant cognitive impairment, low English proficiency, inability to read, and/or inability to understand consent content or explanations provided by investigators
Previous diagnosis of HF (with any ejection fraction and due to any cause)
Receiving renal replacement therapy
Inability to travel to Cleveland Clinic for biomarker or handheld point-of-care echo with AI (receiving hospice or skilled nursing facility care).
Anyone who, in the investigators' opinion, is not suitable to participate in the trial for other reasons e.g. a diagnosis which may compromise survival over the study period; female with a history of left breast mastectomy and breast reconstruction (inability to use AI echocardiogram) or history of only 1 visit to Cleveland Clinic for medical care in any service or with any provider (reflects a lack of using Cleveland Clinic for routine medical care)

What this trial measures

  • New onset HF based on race5 years

    Race (a categorical variable) may be reduced to white vs. all other if other categories have too low a sample size. New-onset heart failure is based on electronic health record documentation of elevated NTproBNP and/or echocardiography results + patient symptoms.

  • New onset HF based on social vulnerability index5 years

    SVI (national data based on zip code) Scores range from 0 to 1, with lower scores equating to less social vulnerability. Note: scores may be categorized into SVI factors are socioeconomic status, household characteristics, racial and ethnic minority status, and housing type and transportation that has 4 categories from low vulnerability to high vulnerability). New onset heart failure is based on electronic health record documentation of elevated NTproBNP and/or echocardiography results + patient symptoms.

  • New onset HF based on marital status5 years

    Marital status (a categorical variable that may be reduced to married vs. not married) if other categories have too low of a sample size. New onset heart failure is based on electronic health record documentation of elevated NTproBNP and/or echocardiography results + patient symptoms.

  • New onset HF based on patients comfort living on income5 years

    Comfort living on income is a single patient reported outcome measure with 3 response options: less than comfortable, comfortable, more than comfortable.New onset heart failure is based on electronic health record documentation of elevated NTproBNP and/or echocardiography results + patient symptoms.

  • New onset HF based on distressed community index (DCI)5 years

    DCI (national database information based on zip code) with 7 categories of data based on home location. Scores are from 0-100 with higher scores equating to a more distressed community. Results can be categorized on 5 levels from distressed to prosperous. New onset heart failure is based on electronic health record documentation of elevated NTproBNP and/or echocardiography results + patient symptoms.

  • New onset HF based on healthcare insurance type5 years

    Insurance type (categorical variable from the hospital billing database that includes government insurance, private insurance, health maintenance organization programs and self-pay), that may be reduced to government vs. other insurance vs. self-pay. New onset heart failure is based on electronic health record documentation of elevated NTproBNP and/or echocardiography results + patient symptoms.

  • New onset HF based on all 6 social determinants that may affect health5 years

    Social determinants of health are defined by results of 6 variables (race, SVI, marital status, comfort living on income, DCI, and insurance type). Each of the 6 variables will receive a score reflecting low, medium or high probability of better health and the combined score will be assessed for association with new onset heart failure over 5 year period (yes/no).