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

Launched by LITHUANIAN UNIVERSITY OF HEALTH SCIENCES · May 27, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how well patients with heart failure and different body weights (measured by Body Mass Index or BMI) can tolerate a medication called Entresto (sacubitril/valsartan). Specifically, researchers want to find out if people with a higher BMI can handle higher doses of this medication and if it helps them feel better and function better compared to those with a lower BMI. The study is currently looking for participants aged 18 and older who have been diagnosed with a specific type of heart failure called heart failure with reduced ejection fraction (HFrEF).

To be eligible for the trial, participants should not have taken Entresto before and must be willing to switch from other heart medications if needed. However, people with serious kidney or liver problems, a history of severe allergic reactions, or other significant health issues may not be able to join. If you participate, you can expect to be monitored for how well you tolerate the medication and how it affects your heart failure symptoms. This trial could help improve treatment options for heart failure patients with different body weights.

Gender

ALL

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