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
This trial does not accept healthy volunteersQualifiers
≥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 population
Among adutls enrolled in SYMPHONY (Glasgow, UK), the EAGLE-HF component will use available data; specifically, NTproBNP, HFrEF diagnosis, 4 classes of HF medications use in first 6 months after diagnosis and race, plus data collected locally for EAGLE-HF on social vulnerability index (SVI), marital status, comfort living on income, distressed community index (DCI), insurance type; physician practice type and medical provider type. to determine if variables are associated with EAGLE-HF outcomes
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
New onset HF based on race
Race (a categorical variable) may be reduced to white vs. all other if other categories have too low a sample size. New-onset heart failure is based on electronic health record documentation of elevated NTproBNP and/or echocardiography results + patient symptoms.
New onset HF based on social vulnerability index
SVI (national data based on zip code) Scores range from 0 to 1, with lower scores equating to less social vulnerability. Note: scores may be categorized into SVI factors are socioeconomic status, household characteristics, racial and ethnic minority status, and housing type and transportation that has 4 categories from low vulnerability to high vulnerability). New onset heart failure is based on electronic health record documentation of elevated NTproBNP and/or echocardiography results + patient symptoms.
New onset HF based on marital status
Marital status (a categorical variable that may be reduced to married vs. not married) if other categories have too low of a sample size. New onset heart failure is based on electronic health record documentation of elevated NTproBNP and/or echocardiography results + patient symptoms.
New onset HF based on patients comfort living on income
Comfort living on income is a single patient reported outcome measure with 3 response options: less than comfortable, comfortable, more than comfortable.New onset heart failure is based on electronic health record documentation of elevated NTproBNP and/or echocardiography results + patient symptoms.
Secondary outcomes
Use of HFrEF core medication classes based on distressed community index (DCI)
DCI score (0-100) comes from a national database that uses zip code to determine community distress (previously described). HFrEF medication "use" score is based on prescription of core 4 classes of medications per the electronic health record: 1) renin-angiotensin system inhibitors (RASi) or hydralazine/nitrate if severe chronic kidney disease or other contraindication, 2) evidenced-based beta blockers (eBB) or ivabradine if beta blockers are contraindicated), 3) mineralocorticoid receptor blocker (MRA), and 4) sodium-glucose co-transporter inhibitor (SGLTi); scoring is based on drug class- 1 to 4.
Dose of HFrEF core medication classes based on distressed community index (DCI)
DCI score (0-100) comes from a national database that uses zip code to determine community distress (previously described). HFrEF medication "dose" score is based on prescription dose of core 4 classes of medications per the electronic health record: 1) RASi or hydralazine/nitrate if severe chronic kidney disease or other contraindication, 2) eBB or ivabradine if beta blockers are contraindicated), 3) MRA, and 4) SGLTi; scoring has 4 categories: not used, \< 50% target dose, 50-100% target dose and \> 100% target dose per national HFrEF guidelines
Use of HFrEF core medication classes based on social vulnerability index (SVI)
SVI score (0-1) comes from a national database that uses zip code to determine social vulnerability (previously described). HFrEF medication "use" score is based on prescription of core 4 classes of medications per the electronic health record: 1) RASi or hydralazine/nitrate if severe chronic kidney disease or other contraindication, 2) eBB or ivabradine if beta blockers are contraindicated, 3) MRA, and 4) SGLTi; scoring is based on drug class- 1 to 4.
Dose of HFrEF core medication classes based on social vulnerability index (SVI)
SVI score (0-1) comes from a national database that uses zip code to determine social vulnerability (previously described). DCI score (0-100) comes from a national database that uses zip code to determine community distress (previously described). HFrEF medication "dose" score is based on prescription dose of core 4 classes of medications per the electronic health record: 1) RASi or hydralazine/nitrate if severe chronic kidney disease or other contraindication, 2) eBB or ivabradine if beta blockers are contraindicated), 3) MRA, and 4) SGLTi; scoring has 4 categories: not used, \< 50% target dose, 50-100% target dose and \> 100% target dose per national HFrEF guidelines.
Other outcomes
Optimal cut-point of NTproBNP for diagnosis of HF in primary care patients meeting study inclusion criteria
In adults who meet inclusion/exclusion criteria for EAGLE-HF and are randomized to the active arm group, NTproBNP mean (standard deviation) values of those who are diagnosed with HF vs. no HF. In those who meet HF criteria (as previously described), cutoff scores may be generated for HFrEF, HFmrEF and HFpEF.
Optimal cut-point of NTproBNP for diagnosis of HF in primary care patients based on social determinants of health (6 factors)
In adults who meet inclusion/exclusion criteria for EAGLE-HF and are randomized to the active arm group, NTproBNP mean (standard deviation) values of those who are diagnosed with HF vs. no HF based on the 6 factors that make up social determinants of health score. Cut-point scores by social determinants of health may be generated for HFrEF, HFmrEF and HFpEF.
Optimal cut-off point of NTproBNP for diagnosis of heart failure in primary care patients based on the number of risk factors for study inclusion (2 to 8)
In adults who are randomized to the active arm group of EAGLE-HF, assess NTproBNP mean (standard deviation) values of those who are diagnosed with HF vs. no HF based on the 8 risk factors for HF development (all patients will have 2 factors and can have up to 8 factors). Cut-point scores by the number of risk factors may be generated for HFrEF, HFmrEF and HFpEF.
Optimal cut-off point of NTproBNP for diagnosis of heart failure in primary care patients based on the 2 most common risk factors for study inclusion
In adults who are randomized to the active arm group of EAGLE-HF, assess NTproBNP mean (standard deviation) values of those who are diagnosed with HF vs. no HF based on the 2 most common risk factors for HF development. Cut-point scores by the 2 most common risk factors may be generated for HFrEF, HFmrEF and HFpEF.
Sponsors and contacts
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The Cleveland Clinic
Lead sponsor
University of Glasgow
Collaborator
Roche Diagnostics GmbH
Collaborator
EchoNous Inc.
Collaborator