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

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

ClinicalTrials.gov Identifier: NCT04143919

Novartis Reference Number: CLCZ696DGT01

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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. 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.

Condition 
Heart Failure
Phase 
Phase 4
Overall status 
Recruiting
Enrollment count 
317 participants
Start date 
Jan 31, 2020
Completion date 
Jun 30, 2020
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

Study Locations

El Salvador
Novartis Investigative Site
Recruiting
San Salvador, 1101
-
El Salvador
Guatemala
Novartis Investigative Site
Recruiting
Guatemala city, 01010
-
Guatemala

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Name: 
Novartis Pharmaceuticals
Phone: 
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]