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

ClinicalTrials.gov Identifier: NCT04143919

Novartis Reference Number: CLCZ696DGT01

Last Update: Oct 26, 2020

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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.

Condition

Heart Failure

Phase

Phase 4

Overall status

Recruiting

Enrollment count

317 participants

Start date

Jan 31, 2020

Completion date

Mar 31, 2021

Gender

All

Age(s)

61 Years - 100 Years (Adult, Older Adult)

Interventions

Diagnostic Test

NYHA assessment

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

Procedure

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.

Diagnostic Test

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

Eligibility Criteria

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