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

EAGLE-HF is Part of a Multinational Group of Studies Titled; Screening for Early Heart Failure Diagnosis and Management in Primary Care or at Home Using Natriuretic Peptides and Echocardiography

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

EAGLE-HF studies how social and community conditions are linked to new cases of heart failure. It also looks at heart failure drug prescribing and how a blood test may help find heart failure. It is for adults age 40 or older in the SYMPHONY study who have trouble with physical activity and risk factors for heart failure.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be enrolled in the SYMPHONY study.
  • Be age 40 or older and willing to sign a form agreeing to join.
  • Have activity test results showing some limits on physical activity or symptoms even at rest.
  • Have at least 2 documented heart failure risk factors from the groups listed below.
  • Risk factors include certain heart or blood vessel diseases, an ongoing irregular heartbeat called atrial fibrillation, or a past stroke caused by a clot.
  • Risk factors include type 1 or type 2 diabetes, or long-term kidney disease that meets the study’s test limits.
  • Risk factors include taking a loop diuretic, a type of water pill, for more than 30 days during the year before agreeing to join.
  • Risk factors include documented COPD, a long-term lung disease that makes breathing hard.

Who can't join

  • Cannot understand or give consent, including because of serious thinking or memory problems, limited English, or trouble reading.
  • Have ever been diagnosed with heart failure.
  • Receive treatment that replaces kidney function, such as dialysis.
  • Cannot travel to Cleveland Clinic for blood tests or a handheld heart ultrasound that uses artificial intelligence, including because of hospice or nursing facility care.
  • Have another condition that, in the study team’s view, may limit survival during the study.
  • Are a woman who has had the left breast removed and rebuilt, which prevents use of the study’s heart ultrasound.
  • Have had only one medical care visit at Cleveland Clinic.
  • The study team believes there is another reason you should not take part.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

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