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Recruiting NCT06439069

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

◆ AI Clinical Summary

This study looks at how a heart failure medication called Entresto works in people with different body weights. Researchers want to see if people who are overweight can safely take higher doses of the medicine and feel better as a result.

Key Objective: This trial is testing whether higher doses of Entresto can be safely given to people with higher BMI and lead to better heart failure symptom relief and improved physical function.

Who to Consider: People with heart failure who have a higher body mass index (BMI) and want to learn if they might benefit from higher doses of Entresto should consider enrolling.

Trial Parameters

Condition Heart Failure
Sponsor Lithuanian University of Health Sciences
Study Type OBSERVATIONAL
Phase N/A
Enrollment 340
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-08-10
Completion 2024-11-01

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.

Eligibility Criteria

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

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