Assessing heart failure management and social factors
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
This study looks at how social factors affect heart failure diagnoses and treatment to help improve care for people newly diagnosed with heart failure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT06849752 on ClinicalTrials.gov |
What this trial studies
EAGLE-HF is an observational study that examines the relationship between social determinants of health and new-onset heart failure diagnoses. It involves participants from the SYMPHONY trial, focusing on those diagnosed with heart failure and assessing medication prescribing patterns among healthcare providers. The study aims to identify optimal NT-proBNP cut-points for diagnosing heart failure based on various social and health factors. By analyzing these associations, the study seeks to improve heart failure management strategies.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 40 and older with documented risk factors for heart failure.
Not a fit: Patients without significant risk factors for heart failure or those under 40 years old may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance heart failure management by integrating social determinants into clinical practice.
How similar studies have performed: Other studies have explored the impact of social determinants on health outcomes, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Cleveland, Ohio
- Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Nancy Albert, PhD — The Cleveland Clinic
- Study coordinator: Nancy M Albert, PhD
- Email: albertn@ccf.org
- Phone: 2163129191
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.