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

NCT06849752 | Recruiting

• 1 other identifier: 23-423
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Socioeconomic Adversity

Keywords

medication prescribing; NTproBNP; Provider type; Social determinants of health

Outcome Measures

Primary Outcomes (7)

• 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.

  5 years

• 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.

  5 years

• 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.

  5 years

• 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.

  5 years

• 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.

  5 years

• 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.

  5 years

• 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).

  5 years

Secondary Outcomes (8)

• Use of HFrEF core medication classes based on distressed community index (DCI)

  6 months post HFrEF diagnosis

• Dose of HFrEF core medication classes based on distressed community index (DCI)

  6 months post HFrEF diagnosis

• Use of HFrEF core medication classes based on social vulnerability index (SVI)

  6 months post HFrEF diagnosis

• Dose of HFrEF core medication classes based on social vulnerability index (SVI)

  6 months post HFrEF diagnosis

• Use of HFrEF core medication classes based on medical provider type

  6 months post HFrEF diagnosis

Other Outcomes (5)

• Optimal cut-point of NTproBNP for diagnosis of HF in primary care patients meeting study inclusion criteria

  Baseline

• Optimal cut-point of NTproBNP for diagnosis of HF in primary care patients based on social determinants of health (6 factors)

  Baseline

• 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)

  Baseline

Study Arms (3)

Test used to diagnose heart failure (NTproBNP) group

Will 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 diagnosis

Medication 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 health

All 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

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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

You may qualify if:

• ≥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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• The Cleveland Clinic: lead
• University of Glasgow: collaborator
• Roche Diagnostics GmbH: collaborator
• EchoNous Inc.: collaborator

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

NTproBNP

MeSH Terms

Conditions

Heart Failure; Financial Stress

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Nancy Albert, PhD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nancy M Albert, PhD

CONTACT

2163129191; albertn@ccf.org

Michelle Levay, MSN

CONTACT

1-216-445-4749; levaym@ccf.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Nursing Officer-Research and Innovation; Senior Nurse Scientist

Study Record Dates

• First Submitted: April 20, 2024
• First Posted: February 27, 2025
• Study Start: March 11, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2031
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: 3 months after enrollment and initial visit completion

Locations

US (1)