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Heart FailureEAGLE-HFNCT06849752

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

An observational study of Heart Failure and Socioeconomic Adversity, run by The Cleveland Clinic at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Heart Failure, Socioeconomic Adversity
How many people
1,000 participants
Where
1 siteUnited States
Study dates
11 Mar 2025to Dec 2031
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study 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

Who may be able to join

None listed.

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Nancy M Albert, PhD contact

2163129191

albertn@ccf.org

Michelle Levay, MSN contact

1-216-445-4749

levaym@ccf.org

United States1 site, 1 recruiting
  • Cleveland Clinic

    Cleveland, Ohio, 44195

    Nancy Albert, PhD, 216-444-7028, albertn@ccf.org

    Michelle Levay, MSN, 2164454749, levaym@ccf.org

    Recruiting

Other trials in United States

About this study

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

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.

Read the 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.

Keywords
medication prescribing, NTproBNP, Provider type, Social determinants of health
Medical subject headings
Heart Failure, Financial Stress

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06849752
Study groupRoleWhat they receive
Test used to diagnose heart failure (NTproBNP) groupWill have a NTproBNP blood test completed at baseline if in the ACTIVE SYMPHONY arm. Baseline NTproBNP test results will be used to assess EAGLE-HF outcomes regarding optimal test cut points for (a) heart failure diagnosis; (b) based on each of the 6 social determinants of health and totla number of social determinants of health; (c) based on risk factors and (d) based on medical comorbidities.
Participants with heart failure diagnosisMedication prescribing patterns in the first 6 months after HFrEF diagnosis will be assessed for association with (a) social vulnerability index, (b) distressed community index, (c) physician practice type (Internal Medicine, Cardiology, HF Cardiology or other provider); and (d) medical provider type (physician, advance practice provider [APP] or PharmD)
Social determinants of healthAll participants will be assessed to determine if 6 factors: race, social vulnerability index (SVI), marital status, comfort living on income, distressed community index (DCI) and insurance type are associated with future assessment of HF via biomarkers (troponin or NT-proBNP) and/or echocardiography over the 5 year assessment period

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 5 years

  5. New onset HF based on distressed community index (DCI)

    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.

    Measured: 5 years

  6. New onset HF based on healthcare insurance type

    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.

    Measured: 5 years

  7. New onset HF based on all 6 social determinants that may affect health

    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).

    Measured: 5 years

Secondary outcomes (8)
  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.

    Measured: 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

    Measured: 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.

    Measured: 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.

    Measured: 6 months post HFrEF diagnosis

  5. Use of HFrEF core medication classes based on medical provider type

    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.

    Measured: 6 months post HFrEF diagnosis

  6. Dose of HFrEF core medication classes based on medical provider type

    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.

    Measured: 6 months post HFrEF diagnosis

  7. Use of HFrEF core medication classes based on physician practice type

    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.

    Measured: 6 months post HFrEF diagnosis

  8. Dose of HFrEF core medication classes based on physician practice type

    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.

    Measured: 6 months post HFrEF diagnosis

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2025
  2. Study start11 Mar 2025
  3. Primary completionJun 2027 (estimated)
  4. Study completionDec 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06849752
Sponsor's protocol ID
23-423
Acronym
EAGLE-HF
Status last verified
May 2026
First submitted
20 Apr 2024
Last updated
8 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Non-EAGLE-HF specific data that is part of SYMPHONY will be deidentified, placed in REDCap, saved as an excel file and will be sent to the SYMPHONY coordinating center every 3 months until all patients are enrolled and 6 month outcomes are completed. After that time, data will be sent at 1, 2 and 5 years post baseline.

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Failure and Socioeconomic Adversity, run by The Cleveland Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Nancy M Albert, PhD (2163129191, albertn@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

New onset HF based on race (time frame: 5 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.

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