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

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
The Cleveland Clinic
Study ID
NCT06849752
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Mar 11, 2025
Status verified
May 2026
Primary completion
Jun 30, 2027
Completion
Dec 31, 2031

Study Design

Enrollment
1,000 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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)
  • Arm: 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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland ClinicClevelandOhio44195
Nancy Albert, PhD
[email protected]
216-444-7028
Michelle Levay, MSN
[email protected]
2164454749

Find similar trials in Cleveland, OH

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
Cleveland Clinic· Cleveland, OH

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