Heart Failure IDentification in a High Risk Cardiovascular OutpatiEnt Population (HIDE)

Study Overview
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Brief Summary
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This is a pilot, multicenter, real-world, single-visit, low risk, phase IV interventional study to efficiently identify new cases of heart failure (HF) Stage C in subjects who are at risk of cardiovascular (CV) disease in high-volume ambulatory primary care settings in 3 countries in Central America.

Detailed Description
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Subjects with 2 or more CV risk factors will be identified and will undergo an NYHA score assessment. If the NYHA score is ≥ II, the serum NT-proBNP concentration will be determined on-site on the same day. If the serum NT proBNP concentration is ≥ 125 pg/mL, the subject will be referred to a country specific central echocardiography laboratory for a transthoracic echocardiogram to measure the left ventricular ejection fraction (LVEF) and relevant structural heart disease.

Official Title
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Heart Failure IDentification in a High Risk Cardiovascular OutpatiEnt Population (HIDE)

Conditions
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Heart Failure

Intervention / Treatment
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* Diagnostic Test: NYHA assessment
* Procedure: Serum NT-proBNP concentration
* Diagnostic Test: Transthoracic Ecocardiogram


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent must be obtained prior to participation in the study Male or female patients aged > 60 years at the time of informed consent Presence of at least 2 or more of the following risk factors for HF (CV risk factors already diagnosed prior to study visit according to the usual medical practice criteria and listed in the medical chart): Hypertension Dyslipidemia Obesity Vascular disease, including coronary artery disease, cerebrovascular disease, and peripheral vascular disease Type 1 or 2 diabetes mellitus Chronic kidney disease Arrhythmia requiring therapy Moderate to severe valvular disease History of alcohol abuse, History of smoking, History of cancer chemotherapy, or i. History of thoracic radiotherapy l. Abnormal findings in the most recent ECG or m. Abnormal findings in the most recent thoracic X-ray Attendance at a primary care consultation for reasons not related to HF Exclusion Criteria: Previous diagnosis of HF Diagnosis of terminal cancer (malignant tumor that may cause the subject's death in a short period: days, weeks, or a few months) Echocardiogram performed within the 12 months before the primary care consultation

Ages Eligible for Study
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Minimum Age: 61 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Interventional Model Description: A recent Cochrane analysis reported a high burden of HF in Latin America (Ciapponi et al 2016), reporting an incidence of HF of 199 cases per 100 000 person-years. A cross-sectional study of 633 individuals aged ≥ 45 years, randomly selected and registered in a primary care program in Brazil (Jorge et al 2016) reported 36.6% of patients with Stage A HF, 42.7% with Stage B, and and 9.3% with symptomatic HF (Stage C). In real world settings primary care physician may attend to up to 40 patients per day, which rose to as many as 70 patients per day during high season demand, meaning in some circunstances physicians may only have up to 12 minutes per patient so patients with HF may go unnoticed. The aim of this study is to assess the practicality of an algorithm to identify new cases of HF Stage C in subjects who are at risk of CV disease in real world high-volume ambulatory primary care settings in Central America.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subjects with CV risk factors<br>Subjects with 2 or more CV risk factors will be identified. Cardiovascular risk factors include hypertension, dyslipidemia, obesity, vascular disease, diabetes mellitus, chronic kidney disease, arrhythmia requiring therapy, moderate to severe valvular disease, history of alcohol abuse, smoking, cancer chemotherapy, or thoracic radiotherapy, and abnormal findings in the most recent ECG or thoracic X-ray. | Diagnostic Test: NYHA assessment<br>* The New York Heart Association (NYHA) functional classification of HF<br>Procedure: Serum NT-proBNP concentration<br>* Subjects with NYHA score ≥ II will undergo a rapid, on site serum NT-proBNP test on the same day of the visit. Roche CARDIAC proBNP+ test, using the Cobas h 232 device, is a quantitative immunological test for the determination of NT-proBNP in heparinized venous blood.<br>Diagnostic Test: Transthoracic Ecocardiogram<br>* Subjects with a serum NT-proBNP result of ≥ 125 pg/mL at Visit 1 will be referred to a study cardiologist for a transthoracic echocardiogram to assess LVEF and relevant structural heart disease<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Cases of HF stage C | Proportion of subjects with HF Stage C among those with 2 or more CV risk factors | 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of number of subjects diagnosed with HF stage C | Comparison of the number of subjects diagnosed with l HF Stage C versus the time matched historical proportion at the same study sites | 5 months | 
| Percentage of subjects with CV risk factos | Percentage of subjects with each listed CV risk factor among those with HF Stage C | 5 months | 
| Percentage of subjects with CV risk factors among participating countries | Percentage of subjects with each listed CV risk factor among participating countries | 5 months | 
| Ratio of subjects with each listed CV risk factor between subjects with and without HF Stage C | Ratio of presence versus absence of each listed CV risk factor between subjects with overall HF Stage C and without HF | 5 months | 
| Incidence of equality of HF Stage C among participating countries | Proportion and equality of proportions of HF Stage C subjects among participating countries | 5 months | 
| Mean NT-proBNP levels among subjects diagnosed with HF Stage C versus subjects with no HF | Comparison of the mean NT-proBNP (≥ 125 pg/mL) levels among subjects diagnosed with overall HF Stage C versus subjects with no HF | 5 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart failure, Cardiovascular risk factors, NT-proBNP, NYHA assessment