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

Obesity Clinical Trial

— BETTER-HF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06439069
• Other study ID #: LUHSKC- 405
• Status: Recruiting
• Start date: August 10, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: May 2024
• Source: Lithuanian University of Health Sciences
• Contact: Ali Aldujeli, MD., MSc
• Phone: +37064874874
• Email: ali.aldujeli[@]kaunoklinikos.lt
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 340
• Est. completion date: December 1, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Obesity

Locations

Country	Name	City	State
Lithuania	Hospital of Lithuanian University of Health Sciences Kaunas Clinics	Kaunas

Sponsors (3)

Lead Sponsor	Collaborator
Lithuanian University of Health Sciences	KlaipÄ-da University, Sligo General Hospital

Country where clinical trial is conducted

Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum 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.	up to 24 weeks
Secondary	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.	up to 24 weeks
Secondary	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.	up to 24 weeks
Secondary	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.	up to 24 weeks
Secondary	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.	up to 24 weeks
Secondary	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.	up to 24 weeks