Evaluating how BMI affects the tolerability and efficacy of Entresto in heart failure patients
BMI-Driven Tolerability and Efficacy of Entresto in Heart Failure Patients
This study is testing how body weight affects how well heart failure patients can tolerate and benefit from the medication Entresto.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 340 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Lithuanian University of Health Sciences Academic / other |
| Locations | 1 site (Kaunas) |
| Trial ID | NCT06439069 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the tolerability and efficacy of Entresto (sacubitril/valsartan) in heart failure patients with reduced ejection fraction (HFrEF) across various BMI categories. It will enroll adults who are either new to Entresto therapy or willing to switch from previous treatments. The study will measure primary outcomes such as the maximum tolerable dose and adverse drug reactions, while secondary outcomes will include changes in heart failure symptoms, functional capacity, hospitalization rates, and mortality. The findings could provide insights into optimal dosing strategies based on BMI.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older diagnosed with heart failure with reduced ejection fraction who are either naïve to Entresto or willing to switch from other therapies.
Not a fit: Patients with severe renal or hepatic impairment, a history of angioedema, or other severe comorbid conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for heart failure patients with varying BMI, enhancing their overall health outcomes.
How similar studies have performed: While this approach is novel in its focus on BMI-driven dosing of Entresto, similar studies have shown the importance of personalized medicine in heart failure treatment.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Kaunas
- Hospital of Lithuanian University of Health Sciences Kaunas Clinics — Kaunas, Lithuania (Recruiting)
Study contacts
- Study coordinator: Ali Aldujeli, MD., MSc
- Email: ali.aldujeli@kaunoklinikos.lt
- Phone: +37064874874
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.