Ignite Creation Date:
2025-12-24 @ 12:15 PM
Ignite Modification Date:
2025-12-24 @ 12:15 PM
Study NCT ID:
NCT06804161
Status:
RECRUITING
Last Update Posted:
2025-12-22
First Post:
2025-01-27
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
SGLT2 Inhibition for Cardiovascular Endpoint Reduction in Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2032-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-15', 'studyFirstSubmitDate': '2025-01-27', 'studyFirstSubmitQcDate': '2025-01-27', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-02-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2032-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Safety endpoints', 'timeFrame': '7 Years', 'description': '* AE (general)\n* AE leading to treatment discontinuation\n* SAE\n* AE of special interest (AESI): including volume depletion, hypotension, metabolic acidosis and ketoacidosis'}], 'primaryOutcomes': [{'measure': 'Time until first occurrence of', 'timeFrame': '7 Years'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atrial Hypertension']}, 'descriptionModule': {'briefSummary': 'Hypertension (HTN) is a leading cause of cardiovascular disease (CVD). Despite existing therapies, patients with HTN still face substantial risks, due to pre-existing and ongoing end-organ damage due, in part, to inadequate blood pressure (BP) control. SGLT2 inhibitors (SGLT2i) are recommended for both type-2 diabetes and heart failure to reduce morbidity and mortality. SGLT2i reduce BP and might also improve outcomes for HTN by reducing end-organ damage through diverse other actions. However, confirmation that SGLT2i are clinically useful for the management of HTN is required to change guidelines and clinical practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age ≥60 years\n2. Systolic blood pressure \\>140 mmHg or diastolic blood pressure \\>90 mmHg in two measurements on different days for newly diagnosed hypertension, or through one measurement at the screening visit for patients with an existing diagnosis of hypertension.\n3. A history of at least one CV event (myocardial infarction\\* or stroke\\*; stable angina or clinical evidence of coronary heart disease; peripheral arterial disease; transient ischemic attack)\n\nor\n\nThe presence of at least one cardiovascular risk factor (current smoking of more than one cigarette per day during at least 1 year; LDL-cholesterol \\> 4,0 mmol/l, Age ≥ 75 years, ESC HeartScore \\> 15%, BMI \\> 32 kg/m2)\n\n\\*excluding patients with myocardial infarction or stroke within preceding 3 months\n\nExclusion Criteria:- Known secondary cause of hypertension\n\n* Myocardial infarction or stroke within the previous 3 months\n* Symptomatic heart failure (including HFrEF, HFmEF, HFpEF)\n* History of Diabetes mellitus\n* History of ketoacidosis\n* Hepatic impairment (aspartate transaminase \\[AST\\] or alanine transaminase \\[ALT\\] \\>3x the upper limit of normal \\[ULN\\])\n* eGFR \\<25 mL/min/1.73 m2 (CKD-EPICr 2021 formula) at Visit 1\n* Receiving therapy with an SGLT2i within 8 weeks prior to randomization or previous intolerance to an SGLT2i\n* Participation in another clinical study with an investigational product during the last month prior to enrolment\n* Known allergy or hypersensitivity to SGLT2i\n* Women who are pregnant, nursing, or who plan to become pregnant while in the trial\n* Any medical condition - outside the renal and CV disease area - with a life expectancy of less than 2 years based on investigator's clinical judgement\n* Active malignancy requiring treatment at the time of visit 1 (with the exception of successfully treated basal cell or treated squamous cell carcinoma)\n* Inability to give informed consent"}, 'identificationModule': {'nctId': 'NCT06804161', 'acronym': 'SGLT2-HYPE', 'briefTitle': 'SGLT2 Inhibition for Cardiovascular Endpoint Reduction in Hypertension', 'organization': {'class': 'OTHER', 'fullName': 'University of Luebeck'}, 'officialTitle': 'SGLT2 Inhibition for Cardiovascular Endpoint Reduction in Hypertension', 'orgStudyIdInfo': {'id': '724154'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SGLT2 Arm', 'interventionNames': ['Drug: SGLT2']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'SGLT2', 'type': 'DRUG', 'description': '10 mg', 'armGroupLabels': ['SGLT2 Arm']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '1 tablet', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23538', 'city': 'Lübeck', 'state': 'Schleswig-Holstein', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Ingo Eitel, Prof. Dr. med.', 'role': 'CONTACT'}, {'name': 'Thomas Stiermaier, Dr.med', 'role': 'CONTACT'}], 'facility': 'Universität zu Lübeck', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}], 'centralContacts': [{'name': 'Ingo Eitel, Prof. Dr.', 'role': 'CONTACT', 'email': 'cvro@uksh.de', 'phone': '045150044542'}, {'name': 'Elias Rawish, Dr.', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Ingo Eitel, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitätsklinikum Schleswig-Holstein - Campus Lübeck'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prof. Dr. med. Ingo Eitel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Head of department of medical clinic II', 'investigatorFullName': 'Prof. Dr. med. Ingo Eitel', 'investigatorAffiliation': 'University of Luebeck'}}}}