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Prevalence of Amyloidosis in Heart Failure (PREVAMIC)

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla · 2020
ClinicalTrials.gov · Datasets · License: Public Domain · 2020
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heart-failure
TITLE: Study of Prevalence of Amyloidosis in Heart Failure: PREVAMIC. DESIGN: Multicenter, observational, cross-sectional, prospective, cohort study with a one-year follow-up. 44 hospitals from Spain will participate. OBJECTIVES. PRIMARY: To estimate the current prevalence of different types of cardiac amyloidosis (CA) in patients with heart failure, aged 65 years and older, with LVH \> 12 mm and any LVEF value, managed in Internal Medicine departments. SECONDARY: To describe the clinical, laboratory and echocardiographic features of patients with CA. To compare one-year readmissions and mortality rates in patients with and without CA. INCLUSION CRITERIA: Inpatients or outpatients with heart failure, aged ≥ 65 years, both genders, under the care of internists. They should have a NYHA Class II-IV, echocardiogram performed in the previous 24 months, any value of LVEF, LVH: septum or posterior wall \> 12 mm, diuretic treatment in the last 6 months and NTproBNP\> 1800 pg/ml or BNP\> 400 pg/ml in acute hear failure, or NT-proBNP \>600 pg/ml o BNP \>150 pg/ml in stable condition. POPULATION: Heart failure outpatients or inpatients of Internal Medicine Services. It is expected to include around 450 patients. ANALYSIS: To calculate the prevalence of TTR-CA and other types of CA. To compare the clinical, analytical, echocardiographic, and readmissions and mortality rates during one-year in patients with and without CA.
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