Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2026-01-01 @ 4:13 AM
Study NCT ID:
NCT06439069
Status:
RECRUITING
Last Update Posted:
2024-06-03
First Post:
2024-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BMI-Driven Tolerability and Efficacy of Entresto in Heart Failure Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 340}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-27', 'studyFirstSubmitDate': '2024-05-27', 'studyFirstSubmitQcDate': '2024-05-27', 'lastUpdatePostDateStruct': {'date': '2024-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum tolerable dose of Entresto achieved', 'timeFrame': 'up to 24 weeks', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Changes in Heart Failure Symptoms (NYHA Classification)', 'timeFrame': 'up to 24 weeks', 'description': '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.'}, {'measure': 'Changes in Functional Capacity (6-Minute Walk Test Distance)', 'timeFrame': 'up to 24 weeks', 'description': '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.'}, {'measure': 'Changes in Quality of Life (KCCQ Score)', 'timeFrame': 'up to 24 weeks', 'description': '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.'}, {'measure': 'Hospitalization Rates', 'timeFrame': 'up to 24 weeks', 'description': '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.'}, {'measure': 'Changes in BNP/NT-proBNP Levels', 'timeFrame': 'up to 24 weeks', 'description': '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.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Heart failure', 'Entresto', 'Obese', 'Sacubitril/Valsartan', 'BMI', 'Tolerability', 'Efficacy', 'NT-proBNP'], 'conditions': ['Heart Failure', 'Obesity']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 18 and older\n* Diagnosed with heart failure with reduced ejection fraction (HFrEF) (LVEF ≤ 35%)\n* Naïve to Entresto therapy or willing to switch from previous ACE inhibitor/ARB therapy\n* Ability to provide informed consent\n\nExclusion Criteria:\n\n* Severe renal or hepatic impairment (e.g., eGFR \\< 30 mL/min/1.73m², severe liver disease)\n* History of angioedema\n* Pregnant or breastfeeding women\n* Patients with malignancies or other severe comorbid conditions\n* Non-compliance with medication regimen'}, 'identificationModule': {'nctId': 'NCT06439069', 'acronym': 'BETTER-HF', 'briefTitle': 'BMI-Driven Tolerability and Efficacy of Entresto in Heart Failure Patients', 'organization': {'class': 'OTHER', 'fullName': 'Lithuanian University of Health Sciences'}, 'officialTitle': 'BMI-Driven Tolerability and Efficacy of Entresto in Heart Failure Patients', 'orgStudyIdInfo': {'id': 'LUHSKC- 405'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Normal Weight (BMI 18.5-24.9)', 'description': '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.'}, {'label': 'Overweight (BMI 25-29.9)', 'description': '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.'}, {'label': 'Obese (BMI 30-34.9)', 'description': '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.'}, {'label': 'Very Obese (BMI ≥ 35)', 'description': '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.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'LT-50161', 'city': 'Kaunas', 'status': 'RECRUITING', 'country': 'Lithuania', 'contacts': [{'name': 'Ali Aldujeli, MD., MSc', 'role': 'CONTACT', 'email': 'ali.aldujeli@kaunoklinikos.lt', 'phone': '+37064874874'}], 'facility': 'Hospital of Lithuanian University of Health Sciences Kaunas Clinics', 'geoPoint': {'lat': 54.90156, 'lon': 23.90909}}], 'centralContacts': [{'name': 'Ali Aldujeli, MD., MSc', 'role': 'CONTACT', 'email': 'ali.aldujeli@kaunoklinikos.lt', 'phone': '+37064874874'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lithuanian University of Health Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sligo General Hospital', 'class': 'OTHER'}, {'name': 'KlaipÄ-da University', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant Cardiologist', 'investigatorFullName': 'Ali Aldujeli', 'investigatorAffiliation': 'Lithuanian University of Health Sciences'}}}}