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

Official title

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

Overview

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.

Detailed description

EAGLE-HF (Early Assessment and initiation of GuideLine-directed Evidence-based management-HF) is a prospective single site observational 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 (available in clinicaltrials.gov). EAGLE-HF is a prospective observational design involving SYMPHONY participants. In EAGLE-HF, patients from SYMPHONY will make up 3 cohorts: all SYMPHONY participants from our site (n=1000), those who had a NT-proBNP test completed (n=500), and those diagnosed with heart failure (unknown, but approximately =50+). EAGLE-HF specific endpoints include examining if social determinants of health (6 factors), social vulnerability index component and overall scores and distressed community index component and overall scores are associated with new onset heart failure. Among patients with NTproBNP data, optimal cut-points for diagnosis of HF will be assessed, including if optimal cut-points are based on social determinants of health, social vulnerability score, distressed community score, risk factors for developing HF and medical comorbidities. Finally, in SYMPHONY participants who are diagnosed with HFrEF within 6 months of enrollment, medication prescribing patterns (use and dose of 4 classes of core HFrEF medications) will be examined, the site investigators will assess if medication prescribing patterns are based on physician practice type and medical provider type.

Primary outcome measures

• 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]

Secondary outcome measures (8)

• Use of HFrEF core medication classes based on distressed community index (DCI) [Time frame: 6 months post HFrEF diagnosis]
• Dose of HFrEF core medication classes based on distressed community index (DCI) [Time frame: 6 months post HFrEF diagnosis]
• Use of HFrEF core medication classes based on social vulnerability index (SVI) [Time frame: 6 months post HFrEF diagnosis]
• Dose of HFrEF core medication classes based on social vulnerability index (SVI) [Time frame: 6 months post HFrEF diagnosis]
• Use of HFrEF core medication classes based on medical provider type [Time frame: 6 months post HFrEF diagnosis]
• Dose of HFrEF core medication classes based on medical provider type [Time frame: 6 months post HFrEF diagnosis]
• Use of HFrEF core medication classes based on physician practice type [Time frame: 6 months post HFrEF diagnosis]
• Dose of HFrEF core medication classes based on physician practice type [Time frame: 6 months post HFrEF diagnosis]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

United States · 1 center

• Cleveland Clinic — Cleveland

Identifiers

NCT: NCT06849752 · 23-423

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗