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

Recruiting
18 years of age
Both
Phase N/A

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Overview

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.

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

Study details

Heart Failure, Obesity

NCT06439069

Lithuanian University of Health Sciences

8 June 2024

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