Recruiting

Heart Failure

Sponsor:

The Cleveland Clinic

Code:

NCT06849752

Conditions

Heart Failure

Socioeconomic Adversity

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

EAGLE-HF (Early Assessment and initiation of GuideLine-directed Evidence-based management-HF) is a prospective single site study of a multinational, unblinded, randomized-controlled, longitudinal trial called SYMPHONY. Primary, secondary and exploratory outcomes that are part of SYMPHONY are not described herein as they replicate SYMPHONY outcomes. Data associated with SYMPHONY outcomes will be sent to the SYMPHONY coordinating center. In EAGLE-HF, site investigators will examine if a new-onset heart failure (HF) diagnosis are asscoiated with social determinants of health (6 factors), social vulnerability index and distressed community indices. In addition, for patients diagnosed with HFrEF, prescribing patterns (use of and dose of) core HF medications will be assessed for association with physician practice type and medical provider type. Finally, (among participants in the SYMPHONY Active arm, an optimal NTproBNP cut-point will be assessed for diagnosis of HF based on social determinants of health, social vulnerability index, distressed community index, HF risk factors and medical comorbidities.

Conditions

Heart Failure

Socioeconomic Adversity

Study ID

NCT06849752

Start date

Mar 11, 2025

Status verified date

May, 2026

Completion date

Dec, 2031

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Inclusion Criteria are patients enrolled in SYMPHONY as described below:

  • ≥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 Criteria:

  • 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)

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

Test used to diagnose heart failure (NTproBNP) group

Will have a NTproBNP blood test completed at baseline if in the ACTIVE SYMPHONY arm. Baseline NTproBNP test results will be used to assess EAGLE-HF outcomes regarding optimal test cut points for (a) heart failure diagnosis; (b) based on each of the 6 social determinants of health and totla number of social determinants of health; (c) based on risk factors and (d) based on medical comorbidities.

Participants with heart failure diagnosis

Medication prescribing patterns in the first 6 months after HFrEF diagnosis will be assessed for association with (a) social vulnerability index, (b) distressed community index, (c) physician practice type (Internal Medicine, Cardiology, HF Cardiology or other provider); and (d) medical provider type (physician, advance practice provider \[APP\] or PharmD)

Social determinants of health

All participants will be assessed to determine if 6 factors: race, social vulnerability index (SVI), marital status, comfort living on income, distressed community index (DCI) and insurance type are associated with future assessment of HF via biomarkers (troponin or NT-proBNP) and/or echocardiography over the 5 year assessment period

Primary outcome measure

  • New onset HF based on race [ Time Frame: 5 years ]
  • New onset HF based on social vulnerability index [ Time Frame: 5 years ]
  • New onset HF based on marital status [ Time Frame: 5 years ]
  • New onset HF based on patients comfort living on income [ Time Frame: 5 years ]
  • New onset HF based on distressed community index (DCI) [ Time Frame: 5 years ]
  • New onset HF based on healthcare insurance type [ Time Frame: 5 years ]
  • New onset HF based on all 6 social determinants that may affect health [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Nancy M Albert, PhD

2163129191albertn@ccf.org

Michelle Levay, MSN

1-216-445-4749levaym@ccf.org

Locations

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Nancy Albert, PhD

216-444-7028albertn@ccf.org

Michelle Levay, MSN

2164454749levaym@ccf.org

More Information

Sponsor

The Cleveland Clinic

Last update posted

May 8, 2026

Last verified

May, 2026

Keywords

  • medication prescribing
  • NTproBNP
  • Provider type
  • Social determinants of health

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-22. This information was provided to ClinicalTrials.gov by The Cleveland Clinic on 2026-05-08. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.