NCT06439069

BMI-Driven Tolerability and Efficacy of Entresto in Heart Failure Patients

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 340 (estimated)
• Sponsor: Lithuanian University of Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Heart Failure
• Obesity

Timeline

• Start date: 2023-08-10
• Primary completion: 2024-11-01
• Completion: 2024-12-01
• First posted: 2024-06-03
• Last updated: 2024-06-03

Locations

1 site across 1 country: Lithuania