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

NCT06439069 | Recruiting DMC

• 1 other identifier: LUHSKC- 405
• Study Type: observational
• Target: 340
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Obesity

Keywords

Heart failure; Entresto; Obese; Sacubitril/Valsartan; BMI; Tolerability; Efficacy; NT-proBNP

Outcome Measures

Primary Outcomes (1)

• Maximum tolerable dose of Entresto achieved

  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.

  up to 24 weeks

Secondary Outcomes (5)

• Changes in Heart Failure Symptoms (NYHA Classification)

  up to 24 weeks

• Changes in Functional Capacity (6-Minute Walk Test Distance)

  up to 24 weeks

• Changes in Quality of Life (KCCQ Score)

  up to 24 weeks

• Hospitalization Rates

  up to 24 weeks

• Changes in BNP/NT-proBNP Levels

  up to 24 weeks

Study Arms (4)

Normal Weight (BMI 18.5-24.9)

Participants with a BMI between 18.5 and 24.9. This group will serve as a reference for normal weight individuals, providing baseline data for comparison with higher BMI categories regarding the tolerability and efficacy of Entresto.

Overweight (BMI 25-29.9)

Participants with a BMI between 25 and 29.9. This group will assess the impact of being overweight on the tolerability and efficacy of Entresto in heart failure patients.

Obese (BMI 30-34.9)

Participants with a BMI between 30 and 34.9. This group will evaluate the effects of obesity on the tolerability and efficacy of Entresto, providing insights into how increased body weight influences treatment outcomes.

Very Obese (BMI ≥ 35)

Participants with a BMI of 35 or higher. This group will explore the challenges and potential benefits of Entresto uptitration in very obese individuals, focusing on the highest BMI category.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study includes adult patients diagnosed with heart failure with reduced ejection fraction (HFrEF) and left ventricular ejection fraction (LVEF) ≤ 40%. Participants are either naïve to Entresto therapy or willing to switch from previous ACE inhibitor/ARB therapy. They will be categorized into four BMI groups: Normal Weight (BMI 18.5-24.9), Overweight (BMI 25-29.9), Obese (BMI 30-34.9), and Very Obese (BMI ≥ 35). Exclusion criteria include severe renal (eGFR \< 30 mL/min/1.73m²) or hepatic impairment, history of angioedema, pregnancy, breastfeeding, active malignancies, severe comorbid conditions, and non-compliance with medication regimens. The study aims to enroll approximately 340 participants, with about 85 in each BMI category. Participants will be recruited from multiple cardiology clinics and hospitals.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lithuanian University of Health Sciences: lead
• Sligo General Hospital: collaborator
• KlaipÄ-da University: collaborator

Study Sites (1)

Hospital of Lithuanian University of Health Sciences Kaunas Clinics

Kaunas, LT-50161, Lithuania

RECRUITING

MeSH Terms

Conditions

Heart Failure; Obesity

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ali Aldujeli, MD., MSc

CONTACT

+37064874874; ali.aldujeli@kaunoklinikos.lt

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Cardiologist

Study Record Dates

• First Submitted: May 27, 2024
• First Posted: June 3, 2024
• Study Start: August 10, 2023
• Primary Completion: November 1, 2024
• Study Completion: December 1, 2024
• Last Updated: June 3, 2024

Record last verified: 2024-05

Locations

LI (1)