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

This trial does not accept healthy volunteers

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 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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

1,000 Participants
are grouped into 3 trial groups
Group A: Test used to diagnose heart failure (NTproBNP) group
Group B: Participants with heart failure diagnosis
Group C: Social determinants of health

Trial outcomes

Primary outcomes

1

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.

Time frame
5 years
2

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.

Time frame
5 years
3

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.

Time frame
5 years
4

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.

Time frame
5 years

Secondary outcomes

1

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.

Time frame
6 months post HFrEF diagnosis
2

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

Time frame
6 months post HFrEF diagnosis
3

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.

Time frame
6 months post HFrEF diagnosis
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.

Time frame
6 months post HFrEF diagnosis

Other outcomes

1

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.

Time frame
Baseline
2

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.

Time frame
Baseline
3

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.

Time frame
Baseline
4

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.

Time frame
Baseline

Sponsors and contacts

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The Cleveland Clinic

Lead sponsor

University of Glasgow

Collaborator

Roche Diagnostics GmbH

Collaborator

EchoNous Inc.

Collaborator