This study aims to determine if patients with higher BMI can tolerate higher doses of Entresto (sacubitril/valsartan) and experience better symptomatic and functional outcomes compared to patients with lower BMI.
This prospective cohort study will enroll heart failure patients with reduced ejection fraction (HFrEF) to evaluate the tolerability and efficacy of Entresto uptitration across different BMI categories (Normal weight, Overweight, Obese, and Very Obese). Primary outcomes include the maximum tolerable dose and incidence of adverse drug reactions. Secondary outcomes include changes in heart failure symptoms, functional capacity measured by the 6-minute walk test, hospitalization rates, and mortality.
Study Type
OBSERVATIONAL
Enrollment
340
Hospital of Lithuanian University of Health Sciences Kaunas Clinics
Kaunas, Lithuania
RECRUITINGMaximum tolerable dose of Entresto achieved
This outcome measures the highest dose of Entresto that patients in each BMI category can tolerate without experiencing significant adverse drug reactions (ADRs). The dose will be recorded at the end of the titration period, which is expected to last up to 24 weeks.
Time frame: up to 24 weeks
Changes in Heart Failure Symptoms (NYHA Classification)
This outcome assesses the changes in heart failure symptoms based on the New York Heart Association (NYHA) classification at baseline and at 1 year follow-up visit. Improvement or worsening of symptoms will be tracked.
Time frame: up to 24 weeks
Changes in Functional Capacity (6-Minute Walk Test Distance)
This outcome measures the distance walked during the 6-minute walk test (6MWT) at baseline and at 1 year follow-up visit. It evaluates the functional capacity and exercise tolerance of participants.
Time frame: up to 24 weeks
Changes in Quality of Life (KCCQ Score)
This outcome assesses changes in the quality of life related to heart failure symptoms, as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ). Scores will be recorded at baseline and at 1 year follow-up visit.
Time frame: up to 24 weeks
Hospitalization Rates
This outcome tracks the number of hospitalizations due to heart failure or related conditions during the study period. It provides an indicator of disease progression and treatment efficacy.
Time frame: up to 24 weeks
Changes in BNP/NT-proBNP Levels
This outcome measures the changes in B-type natriuretic peptide (BNP) or N-terminal pro b-type natriuretic peptide (NT-proBNP) levels, which are biomarkers for heart failure severity, at baseline and at 1 year follow-up visit.
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Time frame: up to 24 weeks