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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- New onset HF based on healthcare insurance type
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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)
研究组 & 干预措施
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
结局指标
主要结局
New onset HF based on healthcare insurance type
时间窗: 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
时间窗: 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).
New onset HF based on race
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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.
次要结局
- 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)
- Dose of HFrEF core medication classes based on medical provider type(6 months post HFrEF diagnosis)
- Use of HFrEF core medication classes based on physician practice type(6 months post HFrEF diagnosis)
- Dose of HFrEF core medication classes based on physician practice type(6 months post HFrEF diagnosis)
研究者
Nancy M. Albert, Ph.D.
Associate Chief Nursing Officer-Research and Innovation; Senior Nurse Scientist
The Cleveland Clinic