Ignite Creation Date:
2025-12-24 @ 6:57 PM
Ignite Modification Date:
2026-01-22 @ 6:40 AM
Study NCT ID:
NCT06507657
Status:
RECRUITING
Last Update Posted:
2025-10-03
First Post:
2024-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Empagliflozin on Left Atrial Function in Adults at Risk for Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C570240', 'term': 'empagliflozin'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'placebo-controlled, double-blinded, randomized pilot study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2029-01-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-01', 'studyFirstSubmitDate': '2024-07-11', 'studyFirstSubmitQcDate': '2024-07-11', 'lastUpdatePostDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-01-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in LA function', 'timeFrame': '9 months', 'description': 'LA function will be quantified by assessing LA reservoir, conduit, and contractile strain with 2DE at baseline and 9 months.'}], 'secondaryOutcomes': [{'measure': 'change in left ventricular ejection fraction', 'timeFrame': '9 months'}, {'measure': 'change in global longitudinal strain', 'timeFrame': '9 months'}, {'measure': 'change in mass (indexed to body surface area)', 'timeFrame': '9 months'}, {'measure': "change in E/e' ratio", 'timeFrame': '9 months'}, {'measure': 'change in plasma protein levels: DLK-1 (protein delta homolog 1)', 'timeFrame': '9 months'}, {'measure': 'change in plasma protein levels: GDF15 (growth differentiating factor 15)', 'timeFrame': '9 months'}, {'measure': 'change in plasma protein levels: Spondin-1', 'timeFrame': '9 months'}, {'measure': 'change in plasma protein levels: IGBPF-7', 'timeFrame': '9 months'}, {'measure': 'change in plasma protein levels: THBS-2 (thrombospondin 2)', 'timeFrame': '9 months'}, {'measure': 'change in plasma protein levels: IGFBP-1 (insulin-like binding factor protein 1)', 'timeFrame': '9 months'}, {'measure': 'change in plasma protein levels: FABP-4 (fatty acid-binding protein 4)', 'timeFrame': '9 months'}, {'measure': 'change in plasma protein levels: CCL16 (C-C motif chemokine 16)', 'timeFrame': '9 months'}, {'measure': 'change in cardiovascular disease biomarker C-reactive protein (CRP)', 'timeFrame': '3 months and 9 months'}, {'measure': 'change in cardiovascular disease biomarker Troponin', 'timeFrame': '3 months and 9 months'}, {'measure': 'change in cardiovascular disease biomarker NT-proBNP', 'timeFrame': '3 months and 9 months'}, {'measure': 'changes in blood pressure ration', 'timeFrame': '1, 3 and 9 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertension', 'Cardiovascular Diseases']}, 'descriptionModule': {'briefSummary': 'Sodium-glucose cotransporter 2 inhibitors (SGLT2i) reduce CVD events, including incident HF. SGLT2 is a glucose transport protein in the kidneys. Inhibition of this protein results in glucosuria and lower serum blood sugar. The SGLT2i medications were initially approved to treat type 2 diabetes (T2D). In 2015, Zinman et al. published the first large randomized clinical trial (RCT) demonstrating a lower composite CVD outcome in adults with T2D treated with empagliflozin compared to placebo (HR 0.85, 95% CI 0.74-0.99). In the specific case of empagliflozin, the hazard ratio was 0.75 (95% CI 0.65-0.86) for HFrEF 8 and 0.79 (95% CI 0.69-0.90) for HFpEF using a treatment dose of 10mg daily.\n\nThe purpose of this placebo-controlled, double-blinded, randomized pilot study is to investigate the effect of empagliflozin on left atrial (LA) function in 80 patients who are at risk for heart failure. Participants will be randomized 1:1 to either intake of a 10mg empagliflozin oral tablet or a matching placebo once daily.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age \\>60 years of age\n* Clinical diagnosis of hypertension\n* Body mass index ≥30kg/m2\n* We will screen for participants with an echocardiogram within 60 days of the baseline visit\n\nExclusion Criteria:\n\n* Female participants who are pregnant, lactating, or of child bearing potential\n* History of type 1 or type 2 diabetes mellitus by medical history or hemoglobin A1c \\>7.0% at Visit 1\n* Clinical diagnosis of HFpEF or HFrEF by participant self-report or documented in the electronic health record\n* Any LVEF measure of ≤40% on past echocardiogram\n* Moderate or severe valve disease on echocardiogram\n* History of genitourinary infection\n* eGFR \\<60 ml/min/1.73 m2 at Visit 1\n* Current treatment with SGLT2 inhibitor, GLP1 agonist, or DPP4 inhibitors\n* Participants in whom coronary revascularization by either PCI or bypass surgery is being contemplated within 6 months, or who have undergone revascularization in the prior 2 months\n* Significant allergy or known intolerance to SGLT2 inhibitors or any ingredient in the formulations\n* Participants currently experiencing any clinically significant or unstable medical condition that might limit their ability to complete the study, or to comply with the requirements of the protocol, including: dermatologic disease, hematological disease, pulmonary disease, hepatic disease, gastrointestinal disease, genitourinary disease, endocrine disease, neurological disease, and psychiatric disease\n* Any malignancy not considered cured (except basal cell carcinoma of the skin). A participant is considered cured if there has been no evidence of cancer recurrence for the 5 years prior to screening\n* Participants who have participated in studies of an investigational drug or device within 30 days prior to the screening visit\n* Inadequate quality echocardiographic images\n* Unstable coronary syndromes\n* Major surgery (major according to the investigator's assessment) performed within 90 days prior to Visit 1 or scheduled major elective surgery within 90 days after Visit 1.\n* Non-English speaking individuals"}, 'identificationModule': {'nctId': 'NCT06507657', 'briefTitle': 'Effect of Empagliflozin on Left Atrial Function in Adults at Risk for Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Effect of Empagliflozin on Left Atrial Function in Adults at Risk for Heart Failure', 'orgStudyIdInfo': {'id': 'CV-2023-32230'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'interventionNames': ['Drug: empagliflozin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'interventionNames': ['Drug: Placebo tablet']}], 'interventions': [{'name': 'empagliflozin', 'type': 'DRUG', 'description': 'intake of a 10mg empagliflozin oral tablet\n\nAt visit 1, after randomization, participants will be provided with bottles containing enough study pills for 3 months duration at 1 tablet daily. Participants will start the study drug on the morning following Visit 1. At the 3 month follow up visit, participants will be provided with enough study pills to complete the remaining 6 months of the study.', 'armGroupLabels': ['Experimental group']}, {'name': 'Placebo tablet', 'type': 'DRUG', 'description': 'intake a placebo oral tablet\n\nAt visit 1, after randomization, participants will be provided with bottles containing enough study pills for 3 months duration at 1 tablet daily. Participants will start the study drug on the morning following Visit 1. At the 3 month follow up visit, participants will be provided with enough study pills to complete the remaining 6 months of the study.', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55414', 'city': 'Minneapolis', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Julie Dicken', 'role': 'CONTACT', 'email': 'dicke022@umn.edu'}], 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'centralContacts': [{'name': 'Julie Dicken, RN', 'role': 'CONTACT', 'email': 'dicke022@umn.edu'}], 'overallOfficials': [{'name': "Jeremy Van't Hof, MD", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}