Clinical trial NCT06849752: Early Assessment and Initiation of GuideLine-Directed Evidence-Based Management-HF
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure
Socioeconomic Adversity
Keywords: medication prescribing
NTproBNP
Provider type
Social determinants of health
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: University of Glasgow
name: Roche Diagnostics GmbH
name: EchoNous Inc.
First posted: 2025-02-27
Enrollment: 1000
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: Inclusion Criteria are patients enrolled in SYMPHONY as described below:

* ≥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).

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)

Primary outcomes:
measure: New onset HF based on race
timeFrame: 5 years
measure: New onset HF based on social vulnerability index
timeFrame: 5 years
measure: New onset HF based on marital status
timeFrame: 5 years
measure: New onset HF based on patients comfort living on income
timeFrame: 5 years
measure: New onset HF based on distressed community index (DCI)
timeFrame: 5 years
measure: New onset HF based on healthcare insurance type
timeFrame: 5 years
measure: New onset HF based on all 6 social determinants that may affect health
timeFrame: 5 years
Secondary outcomes:
measure: Use of HFrEF core medication classes based on distressed community index (DCI)
timeFrame: 6 months post HFrEF diagnosis
measure: Dose of HFrEF core medication classes based on distressed community index (DCI)
timeFrame: 6 months post HFrEF diagnosis
measure: Use of HFrEF core medication classes based on social vulnerability index (SVI)
timeFrame: 6 months post HFrEF diagnosis
measure: Dose of HFrEF core medication classes based on social vulnerability index (SVI)
timeFrame: 6 months post HFrEF diagnosis
measure: Use of HFrEF core medication classes based on medical provider type
timeFrame: 6 months post HFrEF diagnosis
measure: Dose of HFrEF core medication classes based on medical provider type
timeFrame: 6 months post HFrEF diagnosis
measure: Use of HFrEF core medication classes based on physician practice type
timeFrame: 6 months post HFrEF diagnosis
measure: Dose of HFrEF core medication classes based on physician practice type
timeFrame: 6 months post HFrEF diagnosis
Other outcomes:
measure: Optimal cut-point of NTproBNP for diagnosis of HF in primary care patients meeting study inclusion criteria
timeFrame: Baseline
measure: Optimal cut-point of NTproBNP for diagnosis of HF in primary care patients based on social determinants of health (6 factors)
timeFrame: Baseline
measure: 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)
timeFrame: Baseline
measure: 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
timeFrame: Baseline
measure: Optimal cut-off point of NTproBNP for diagnosis of heart failure based on medical comorbidity score
timeFrame: Baseline
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Nancy Albert, PhD
role: PRINCIPAL_INVESTIGATOR
References: