Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2025-12-26 @ 3:08 AM
Study NCT ID:
NCT00282620
Status:
UNKNOWN
Last Update Posted:
2007-11-20
First Post:
2006-01-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Magnesium to Reduce Implantable Cardioverter Defibrillator (ICD) Shocks and Improve Patient's Quality of Life.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-03', 'completionDateStruct': {'date': '2008-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2007-11-16', 'studyFirstSubmitDate': '2006-01-25', 'studyFirstSubmitQcDate': '2006-01-25', 'lastUpdatePostDateStruct': {'date': '2007-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-01-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cumulative occurrence of ICD shocks and patient perceived quality of life at baseline, 3,6,9, and 12 months'}], 'secondaryOutcomes': [{'measure': 'Change in QTc interval in the total population and the subgroup receiving class III antiarrhythmics at baseline, 3, 6, 9, 12 months.'}, {'measure': 'Intracellular magnesium concentrations at baseline, 3 and 12 months'}, {'measure': 'Incidence of supraventricular arrhythmias, ventricular arrhythmias, and sinus tachycardias at baseline, 3,6,9,12 months.'}, {'measure': 'Ventricular fibrillation cycle length and the variability in VFCL at baseline, 3,6,9,12 months'}, {'measure': 'Adverse events at basline, 3,6,9,12 months. Total Hospital Costs and Cost-effectiveness.'}]}, 'conditionsModule': {'keywords': ['Implantable Cardioverter Defibrillator', 'Magnesium', 'Electrocardiogram', 'Ventricular Arrhythmia'], 'conditions': ['Arrhythmia', 'Quality of Life', 'Hypomagnesemia']}, 'descriptionModule': {'briefSummary': 'This study is being conducted to see if magnesium can reduce the number of shocks patients with ICDs experience and to see if magnesium supplementation improves patients quality of life.', 'detailedDescription': "Not all ICD shocks are for ventricular arrhythmias. Some patients receive shocks when they have arrhythmias in the atria (top chambers of the heart). These are called inapproriate shocks, but the pain is similar to the pain patients feel with an appropriate shock (a shock for a ventricular arrhythmia). This study is being conducted to determine if taking magnesium can reduce the number of shocks patients with ICDs experience and to see if magnesium supplementation improves patients quality of life. Magnesium's impact of the electrocardiogram (ECG) and intracellular magnesium concentrations will also be studied.\n\nComparison: Magnesium compared to placebo in patients with ICDs to evaluate the number of ICD shocks and patient perceived quality of life."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:newly implanted ICD or recent ICD shock (within 6 months) -\n\nExclusion Criteria:inability to swallow, a non-cardiac disease with a survival prognosis of less than 12 months, hypermagnesemia, a creatinine clearance less than 30mL/min, lactic acidosis or systemic acidosis syndrome, or previous intolerance to magnesium L-lactate.\n\n\\-'}, 'identificationModule': {'nctId': 'NCT00282620', 'briefTitle': "Magnesium to Reduce Implantable Cardioverter Defibrillator (ICD) Shocks and Improve Patient's Quality of Life.", 'organization': {'class': 'OTHER', 'fullName': 'Hartford Hospital'}, 'officialTitle': 'The Adjuvant Magnesium Trial (AdMag): Assessment if the Impact of Oral Magnesium on ICD Firing and Quality of Life', 'orgStudyIdInfo': {'id': 'KLUG001817HE'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Magnesium L-lactate', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06102-5037', 'city': 'Hartford', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jeffrey Kluger, MD', 'role': 'CONTACT', 'email': 'JKluger@harthosp.org', 'phone': '860-545-2883'}, {'name': 'Charles M White, PharmD', 'role': 'CONTACT', 'email': 'Cmwhite@harthosp.org', 'phone': '860-545-2221'}, {'name': 'Jeffrey Kluger, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Charles M White, PharmD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Nickole N Henyan, PharmD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Stephen D Sander, PharmD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Craig I Coleman, PharmD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Effie L Gillespie, PharmD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Christopher A Clyne, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'William L Baker, PharmD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hartford Hospital', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}], 'centralContacts': [{'name': 'Jeffrey Kluger, MD', 'role': 'CONTACT', 'email': 'Jkluger@harthosp.org', 'phone': '860-545-2883'}, {'name': 'Charles M White, PharmD', 'role': 'CONTACT', 'email': 'Cmwhite@harthosp.org', 'phone': '860-545-2221'}], 'overallOfficials': [{'name': 'Jeffrey Kluger, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hartford Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hartford Hospital', 'class': 'OTHER'}}}}