Heart FailureBETTER-HFNCT06439069
BMI-Driven Tolerability and Efficacy of Entresto in Heart Failure Patients
An observational study of Heart Failure and Obesity, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Obesity
- How many people
- 340 participants
- Where
- 1 siteLithuania
- Study dates
- 10 Aug 2023to 1 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Lithuania1 site, 1 recruiting
- Recruiting
Hospital of Lithuanian University of Health Sciences Kaunas Clinics
Kaunas, LT-50161
Ali Aldujeli, MD., MSc, +37064874874, ali.aldujeli@kaunoklinikos.lt
About this study
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.
Read the 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.
- Conditions
- Heart Failure, Obesity
- Keywords
- Heart failure, Entresto, Obese, Sacubitril/Valsartan, BMI, Tolerability, Efficacy, NT-proBNP
- Medical subject headings
- Heart Failure, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 24 weeks
Secondary outcomes (5)
Changes in Heart Failure Symptoms (NYHA Classification)
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.
Measured: up to 24 weeks
Changes in Functional Capacity (6-Minute Walk Test Distance)
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.
Measured: up to 24 weeks
Changes in Quality of Life (KCCQ Score)
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.
Measured: up to 24 weeks
Hospitalization Rates
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.
Measured: up to 24 weeks
Changes in BNP/NT-proBNP Levels
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.
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start10 Aug 2023
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lithuanian University of Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Sligo General Hospital, Klaipėda University
- Responsible party
- Principal investigator, Ali Aldujeli, Lithuanian University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06439069
- Sponsor's protocol ID
- LUHSKC- 405
- Acronym
- BETTER-HF
- Status last verified
- May 2024
- First submitted
- 27 May 2024
- Last updated
- 3 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BMI-Driven Tolerability and Efficacy of Entresto in Heart Failure Patients
- ClinicalTrials.gov ID
- NCT06439069
- Acronym / sponsor ID
- BETTER-HF / LUHSKC- 405
- Conditions
- Heart Failure, Obesity
- Keywords
- Heart failure, Entresto, Obese, Sacubitril/Valsartan, BMI, Tolerability, Efficacy, NT-proBNP
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- Lithuanian University of Health SciencesUniversity, hospital or other
- Collaborators
- Sligo General Hospital, Klaipėda University
- Study start
- 10 Aug 2023 (actual)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 3 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Maximum tolerable dose of Entresto achieved
Time frame: 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.
5 secondary outcomes
Changes in Heart Failure Symptoms (NYHA Classification)
Time frame: up to 24 weeks
Changes in Functional Capacity (6-Minute Walk Test Distance)
Time frame: up to 24 weeks
Changes in Quality of Life (KCCQ Score)
Time frame: up to 24 weeks
Hospitalization Rates
Time frame: up to 24 weeks
Changes in BNP/NT-proBNP Levels
Time frame: up to 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Obesity, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ali Aldujeli, MD., MSc (+37064874874, ali.aldujeli@kaunoklinikos.lt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerable dose of Entresto achieved (time frame: up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2024.