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

Last updated: May 27, 2024
Sponsor: Lithuanian University of Health Sciences
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hyponatremia

Heart Failure

Congestive Heart Failure

Treatment

N/A

Clinical Study ID

NCT06439069
LUHSKC- 405
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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/ARBtherapy

  • Ability to provide informed consent

Exclusion

Exclusion Criteria:

  • Severe renal or hepatic impairment (e.g., eGFR < 30 mL/min/1.73m², severe liverdisease)

  • History of angioedema

  • Pregnant or breastfeeding women

  • Patients with malignancies or other severe comorbid conditions

  • Non-compliance with medication regimen

Study Design

Total Participants: 340
Study Start date:
August 10, 2023
Estimated Completion Date:
December 01, 2024

Study 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.

Connect with a study center

  • Hospital of Lithuanian University of Health Sciences Kaunas Clinics

    Kaunas, LT-50161
    Lithuania

    Active - Recruiting

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