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

Novartis

Status: Completed

Conditions: Heart Failure

Treatments: Diagnostic Test: Transthoracic Ecocardiogram; Procedure: Serum NT-proBNP concentration; Diagnostic Test: NYHA assessment

Study type: Interventional

Funder types: Industry

Identifiers

NCT04143919

CLCZ696DGT01

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 317 patients

Sex: All

Ages: 61 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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317 participants in 1 patient group

Subjects with CV risk factors

Experimental group

Description:

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.

Treatment:

Procedure: Serum NT-proBNP concentration

Diagnostic Test: NYHA assessment

Diagnostic Test: Transthoracic Ecocardiogram