Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
300

Summary

Conditions
Heart Failure
Type
Interventional
Phase
Phase 4
Design
Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: 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.Masking: None (Open Label)Primary Purpose: Screening

Participation Requirements

Age
Between 61 years and 100 years
Gender
Both males and females

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 countr...

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.

Tracking Information

NCT #
NCT04143919
Collaborators
Not Provided
Investigators
Study Director: Novartis Pharmaceutical Novartis Pharmaceutical