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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SCREENING
Masking
NONE
Enrollment
317
The New York Heart Association (NYHA) functional classification of HF
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.
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
Novartis Investigative Site
Santo Domingo, Dominican Republic
Novartis Investigative Site
Santo Domingo, Dominican Republic
Novartis Investigative Site
San Salvador, El Salvador
Novartis Investigative Site
Guatemala City, Guatemala
Number of Cases of HF stage C
Proportion of subjects with HF Stage C among those with 2 or more CV risk factors
Time frame: 5 months
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
Time frame: 5 months
Percentage of subjects with CV risk factos
Percentage of subjects with each listed CV risk factor among those with HF Stage C
Time frame: 5 months
Percentage of subjects with CV risk factors among participating countries
Percentage of subjects with each listed CV risk factor among participating countries
Time frame: 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
Time frame: 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
Time frame: 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
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Novartis Investigative Site
Guatemala City, Guatemala
Time frame: 5 months