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

Recruiting

• Conditions: Heart Failure; Socioeconomic Adversity

• Registration Number: NCT06849752
• Lead Sponsor: The Cleveland Clinic

Brief Summary

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.

Study Timeline

• Study First Submitted: 2024-04-20
• Study First Submitted QC: 2025-02-23
• Study First Posted: 2025-02-27
• Status Verified: 2025-03
• Study Start: 2025-03-11
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-19
• Primary Completion: 2027-06
• Study Completion: 2031-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

Not provided

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
New onset HF based on race	5 years	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	5 years	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	5 years	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	5 years	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.
New onset HF based on distressed community index (DCI)	5 years	DCI (national database information based on zip code) with 7 categories of data based on home location. Scores are from 0-100 with higher scores equating to a more distressed community. Results can be categorized on 5 levels from distressed to prosperous. 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 healthcare insurance type	5 years	Insurance type (categorical variable from the hospital billing database that includes government insurance, private insurance, health maintenance organization programs and self-pay), that may be reduced to government vs. other insurance vs. self-pay. 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 all 6 social determinants that may affect health	5 years	Social determinants of health are defined by results of 6 variables (race, SVI, marital status, comfort living on income, DCI, and insurance type). Each of the 6 variables will receive a score reflecting low, medium or high probability of better health and the combined score will be assessed for association with new onset heart failure over 5 year period (yes/no).

Secondary Outcome Measures

Name	Time	Method
Use of HFrEF core medication classes based on distressed community index (DCI)	6 months post HFrEF diagnosis	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)	6 months post HFrEF diagnosis	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)	6 months post HFrEF diagnosis	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)	6 months post HFrEF diagnosis	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.
Use of HFrEF core medication classes based on medical provider type	6 months post HFrEF diagnosis	Medical provider type refers to prescribers of HF medications- 3 categories 1) physician; 2) advanced practice provider (nurse or physician assistant); 3) pharmacist (PharmD). The medication prescribing patterns were previously described as prescription of up to 4 classes of heart failure medications: 1) RASI; 2) eBB; 3) MRA; 4) SGLTi.
Dose of HFrEF core medication classes based on medical provider type	6 months post HFrEF diagnosis	Medical provider type refers to prescribers of HF medications- 3 categories 1) physician; 2) advanced practice provider (nurse or physician assistant); 3) pharmacist (PharmD). 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 physician practice type	6 months post HFrEF diagnosis	Physician practice type is defined as 1 of 4 categories of primary provider type who manage patients with HFrEF: 1) internal medicine/family practice; 2) cardiology; 3) heart failure specialty cardiology; and 4) other provider. 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 physician practice type	6 months post HFrEF diagnosis	Physician practice type is defined as 1 of 4 categories of primary provider type who manage patients with HFrEF: 1) internal medicine/family practice; 2) cardiology; 3) heart failure specialty cardiology; and 4) other provider. 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.

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States