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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40+
SponsorThe Cleveland Clinic

About this trial

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.

Eligibility criteria

Qualifiers

≥40 years old at enrollment

Willing to sign informed consent

Specific Activity Scale results that match a NYHA-FC score II-IV

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)

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

1,000 Participants
are grouped into 3 trial groups

Sponsors and collaborators

The Cleveland Clinic

Lead sponsor

University of Glasgow

Collaborator

Roche Diagnostics GmbH

Collaborator

EchoNous Inc.

Collaborator