BMI-Driven Tolerability and Efficacy of Entresto in Heart Failure Patients (BETTER-HF)

Lithuanian University of Health Sciences

Status: Enrolling

Conditions: Obesity; Heart Failure

Study type: Observational

Funder types: Other

Identifiers

NCT06439069

LUHSKC- 405

Details and patient eligibility

About

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.

Full 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.

Enrollment: 340 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

340 participants in 4 patient groups

Normal Weight (BMI 18.5-24.9)

Description:

Participants with a BMI between 18.5 and 24.9. This group will serve as a reference for normal weight individuals, providing baseline data for comparison with higher BMI categories regarding the tolerability and efficacy of Entresto.

Overweight (BMI 25-29.9)

Description:

Participants with a BMI between 25 and 29.9. This group will assess the impact of being overweight on the tolerability and efficacy of Entresto in heart failure patients.

Obese (BMI 30-34.9)

Description:

Participants with a BMI between 30 and 34.9. This group will evaluate the effects of obesity on the tolerability and efficacy of Entresto, providing insights into how increased body weight influences treatment outcomes.

Very Obese (BMI ≥ 35)

Description:

Participants with a BMI of 35 or higher. This group will explore the challenges and potential benefits of Entresto uptitration in very obese individuals, focusing on the highest BMI category.