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

Recruiting

• Conditions: Heart Failure; Obesity

• Registration Number: NCT06439069
• Lead Sponsor: Lithuanian University of Health Sciences

Brief 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.

Study Timeline

• Study Start: 2023-08-10
• Status Verified: 2024-05
• Study First Submitted: 2024-05-27
• Study First Submitted QC: 2024-05-27
• Last Update Submitted: 2024-05-27
• Study First Posted: 2024-06-03
• Last Update Posted: 2024-06-03
• Primary Completion: 2024-11-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 340

Inclusion Criteria

• Adults aged 18 and older
• Diagnosed with heart failure with reduced ejection fraction (HFrEF) (LVEF ≤ 35%)
• Naïve to Entresto therapy or willing to switch from previous ACE inhibitor/ARB therapy
• Ability to provide informed consent

Exclusion Criteria

• Severe renal or hepatic impairment (e.g., eGFR < 30 mL/min/1.73m², severe liver disease)
• History of angioedema
• Pregnant or breastfeeding women
• Patients with malignancies or other severe comorbid conditions
• Non-compliance with medication regimen

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maximum tolerable dose of Entresto achieved	up to 24 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Changes in Heart Failure Symptoms (NYHA Classification)	up to 24 weeks	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.
Changes in Functional Capacity (6-Minute Walk Test Distance)	up to 24 weeks	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.
Changes in Quality of Life (KCCQ Score)	up to 24 weeks	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.
Changes in BNP/NT-proBNP Levels	up to 24 weeks	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.
Hospitalization Rates	up to 24 weeks	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.

Trial Locations

Locations (1)

Hospital of Lithuanian University of Health Sciences Kaunas Clinics; 🇱🇹 Kaunas, Lithuania