Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2026-01-01 @ 1:29 AM
Study NCT ID:
NCT06233695
Status:
COMPLETED
Last Update Posted:
2024-02-26
First Post:
2024-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gender-based Differences in the Outcome of Treatment With Aldosterone Antagonists in Patients With Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D003075', 'term': 'Coitus'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D012725', 'term': 'Sexual Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026941', 'term': 'Sodium Channel Blockers'}], 'ancestors': [{'id': 'D049990', 'term': 'Membrane Transport Modulators'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D002317', 'term': 'Cardiovascular Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-23', 'studyFirstSubmitDate': '2024-01-13', 'studyFirstSubmitQcDate': '2024-01-28', 'lastUpdatePostDateStruct': {'date': '2024-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Heart failure hospitalization', 'timeFrame': '6 months after enrollment', 'description': 'The incidence of Hospitalization due to heart failure'}, {'measure': 'Acute myocardial infarction', 'timeFrame': '6 months after enrollment', 'description': 'The incidence of acute myocardial infarction'}, {'measure': 'Percentage of patients who discontinued mineralocorticoid receptor antagonist', 'timeFrame': '6 months after enrollment', 'description': 'Discontinuation of mineralocorticoid receptor antagonist'}, {'measure': 'Switching from one mineralocorticoid receptor antagonist to another', 'timeFrame': '6 months after enrollment', 'description': 'Changing the mineralocorticoid receptor antagonist used'}, {'measure': 'Acute Kidney Injury', 'timeFrame': '6 months after enrollment', 'description': 'The incidence of acute kidney injury'}, {'measure': 'Adverse effects', 'timeFrame': '6 months after enrollment', 'description': 'The occurrence of Hyperkalemia, hypochloremic alkalosis, dehydration, or MRA adverse effects'}], 'secondaryOutcomes': [{'measure': 'All-cause hospitalization rate', 'timeFrame': '6 months after enrollment', 'description': 'Hospitalization due to any cause including heart failure'}, {'measure': 'All-cause mortality rate', 'timeFrame': '6 months after enrollment', 'description': 'Death due to any cause'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Heart Failure', 'Heart Failure with Reduced Ejection Fraction', 'Gender', 'Eplerenone', 'Spironolactone', 'Hospitalization'], 'conditions': ['Heart Failure', 'Heart Failure With Reduced Ejection Fraction', 'Heart Failure NYHA Class II', 'Heart Failure NYHA Class III', 'Heart Failure NYHA Class IV']}, 'descriptionModule': {'briefSummary': 'Heart failure (HF) is a major healthcare problem. In patients with Heart Failure with Reduced Ejection Fraction (HFrEF), aldosterone antagonists reduce mortality and hospitalization rate. Gender-related differences have been described in the regulation of renin angiotensin aldosterone system (RAAS), which is at the core of the pathophysiology of HF. Regarding gender-related differences in the use of MRAs, less is known about the effects of androgens on RAAS.\n\nIn this single-center prospective cohort, a total of 100 adult (≥ 18 years) ambulatory patients of both sexes with the diagnosis of HF with HFrEF (LVEF≤ 40%) and NYHA class II-IV under optimized medical therapy started an aldosterone antagonist are enrolled and followed-up for 6 months. Patients are categorized according to their apparent sexual gender into two groups: the male group and the female group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'New York Heart Association (NYHA) class II-IV heart failure with reduced ejection fraction HFrEF patients (LVEF≤ 40%).', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The diagnosis of heart failure with reduced ejection fraction HFrEF (LVEF≤ 40%) and New York Heart Association (NYHA) class II-IV under optimized medical therapy who are presented to the outpatient clinic and started an aldosterone antagonist at the time of enrollment.\n\nExclusion Criteria:\n\n* Pregnancy or breast-feeding.\n* Serum creatinine \\> 2.5 mg/dL (221 μmol/L) in males and \\> 2 mg/dL (177 μmol/L) in women (or estimated glomerular filtration rate eGFR ≤ 30 mL/minute/1.73 m2).\n* Hyperkalemia (serum potassium level \\> 5 mEq/L).\n* Renal transplant.\n* Concomitant administration of strong CYP3A inhibitors.\n* Concomitant administration of potassium supplements or potassium-sparing diuretics.\n* Disorders of adrenal glands (Addison disease).\n* Patients who used mineralocorticoid receptor antagonists in the last 2 weeks before enrollment.\n* Patients with a history of mineralocorticoid receptor antagonists allergy or intolerance.'}, 'identificationModule': {'nctId': 'NCT06233695', 'acronym': 'GBDAL-HF', 'briefTitle': 'Gender-based Differences in the Outcome of Treatment With Aldosterone Antagonists in Patients With Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'The Gender-Based Differences in the Outcome of Treatment by Aldosterone Antagonists in Patients With Heart Failure', 'orgStudyIdInfo': {'id': 'GBDAL-HF Trial'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'The Female Group', 'description': 'Patients with an apparent gender of female.', 'interventionNames': ['Drug: Potassium sparing diuretic']}, {'label': 'The Male Group', 'description': 'Patients with an apparent gender of male.', 'interventionNames': ['Drug: Potassium sparing diuretic']}], 'interventions': [{'name': 'Potassium sparing diuretic', 'type': 'DRUG', 'description': 'Starting Spironolactone or Eplerenone at the time of enrollment.', 'armGroupLabels': ['The Female Group', 'The Male Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Faculty of Medicine, Alexandria University Hospitals', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}], 'overallOfficials': [{'name': 'Salah Abdelkader, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cardiology Department, Faculty of Medicine, Alexandria University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexandria University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}