NCT06849752 Early Assessment and Initiation of GuideLine-Directed Evidence-Based Management-HF
| NCT ID | NCT06849752 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Cleveland Clinic |
| Condition | Heart Failure |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2025-03-11 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2025-03-11 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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)
Contact & Investigator
Nancy Albert, PhD
PRINCIPAL INVESTIGATOR
The Cleveland Clinic
Frequently Asked Questions
Who can join the NCT06849752 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06849752 currently recruiting?
Yes, NCT06849752 is actively recruiting participants. Contact the research team at albertn@ccf.org for enrollment information.
Where is the NCT06849752 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT06849752 clinical trial?
NCT06849752 is sponsored by The Cleveland Clinic. The principal investigator is Nancy Albert, PhD at The Cleveland Clinic. The trial plans to enroll 1,000 participants.
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