Heart Failure, Obesity
Conditions
Keywords
Heart failure, Entresto, Obese, Sacubitril/Valsartan, BMI, Tolerability, Efficacy, NT-proBNP
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.
Detailed 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.
Interventions
None listed
Sponsors
Sligo General Hospital
KlaipÄ-da University
Lithuanian University of Health Sciences
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum tolerable dose of Entresto achieved | up to 24 weeks | This outcome measures the highest dose of Entresto that patients in each BMI category can tolerate without experiencing significant adverse drug reactions (ADRs). The dose will be recorded at the end of the titration period, which is expected to last up to 24 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Heart Failure Symptoms (NYHA Classification) | up to 24 weeks | This outcome assesses the changes in heart failure symptoms based on the New York Heart Association (NYHA) classification at baseline and at 1 year follow-up visit. Improvement or worsening of symptoms will be tracked. |
| Changes in Functional Capacity (6-Minute Walk Test Distance) | up to 24 weeks | This outcome measures the distance walked during the 6-minute walk test (6MWT) at baseline and at 1 year follow-up visit. It evaluates the functional capacity and exercise tolerance of participants. |
| Changes in Quality of Life (KCCQ Score) | up to 24 weeks | This outcome assesses changes in the quality of life related to heart failure symptoms, as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ). Scores will be recorded at baseline and at 1 year follow-up visit. |
| Hospitalization Rates | up to 24 weeks | This outcome tracks the number of hospitalizations due to heart failure or related conditions during the study period. It provides an indicator of disease progression and treatment efficacy. |
| Changes in BNP/NT-proBNP Levels | up to 24 weeks | This outcome measures the changes in B-type natriuretic peptide (BNP) or N-terminal pro b-type natriuretic peptide (NT-proBNP) levels, which are biomarkers for heart failure severity, at baseline and at 1 year follow-up visit. |
Countries
Lithuania
Contacts
Primary ContactAli Aldujeli, MD., MSc
Outcome results
None listed