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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

317 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-31

Study Completion Date

2021-06-11

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.

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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.

Conditions

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Heart Failure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Subjects with CV risk factors

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.

Group Type EXPERIMENTAL

NYHA assessment

Intervention Type DIAGNOSTIC_TEST

The New York Heart Association (NYHA) functional classification of HF

Serum NT-proBNP concentration

Intervention Type PROCEDURE

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.

Transthoracic Ecocardiogram

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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NYHA assessment

The New York Heart Association (NYHA) functional classification of HF

Intervention Type DIAGNOSTIC_TEST

Serum NT-proBNP concentration

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.

Intervention Type PROCEDURE

Transthoracic Ecocardiogram

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. Signed informed consent must be obtained prior to participation in the study
2. Male or female patients aged \> 60 years at the time of informed consent
3. 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):

1. Hypertension
2. Dyslipidemia
3. Obesity
4. Vascular disease, including coronary artery disease, cerebrovascular disease, and peripheral vascular disease
5. Type 1 or 2 diabetes mellitus
6. Chronic kidney disease
7. Arrhythmia requiring therapy
8. Moderate to severe valvular disease
9. History of alcohol abuse,
10. History of smoking,
11. 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
4. Attendance at a primary care consultation for reasons not related to HF

Exclusion Criteria

1. Previous diagnosis of HF
2. Diagnosis of terminal cancer (malignant tumor that may cause the subject's death in a short period: days, weeks, or a few months)
3. Echocardiogram performed within the 12 months before the primary care consultation

Minimum Eligible Age

61 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No