Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2026-04-15 @ 12:39 PM
Study NCT ID:
NCT01852994
Status:
COMPLETED
Last Update Posted:
2016-12-15
First Post:
2013-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise Training and Testosterone Replacement in Heart Failure Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C010792', 'term': 'testosterone undecanoate'}, {'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-14', 'studyFirstSubmitDate': '2013-03-11', 'studyFirstSubmitQcDate': '2013-05-09', 'lastUpdatePostDateStruct': {'date': '2016-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Microneurography', 'timeFrame': '4 months of exercise training/testosterone replacement', 'description': 'Muscle sympathetic nerve activity (MSNA) is recorded directly from the peroneal nerve using the microneurography technique. Multiunit postganglionic muscle sympathetic nerve recordings is made using a tungsten microelectrode. All of the recordings of MSNA met previously established and described criteria. MSNA is quantified as burst frequency (bursts per minute).'}, {'measure': 'Forearm blood flow', 'timeFrame': '4 months of exercise training/testosterone replacement', 'description': 'Forearm blood flow is measured by venous occlusion plethysmography. The nondominant arm is elevated above heart level to ensure adequate venous drainage. A mercury-filled silastic tube attached to a low-pressure transducer is placed around the forearm and connected to a plethysmography. Forearm blood flow is determined on the basis of a minimum off four separate readings. Forearm vascular conductance is calculated by dividing forearm blood flow by mean arterial pressure times 100 and expressed in arbitrary units.'}], 'secondaryOutcomes': [{'measure': 'Cardiopulmonary exercise', 'timeFrame': '4 months of exercise training/testosterone replacement', 'description': 'The maximal cardiopulmonary test is carried out on a bike using a ramp protocol with workload increment every minute with energetic demand of about 1 metabolic equivalent(MET) per minute or 3.5 mL/Kg.min of oxygen uptake.'}, {'measure': 'Body composition', 'timeFrame': '4 months of exercise training/testosterone replacement', 'description': 'Body composition and bone mineral density is determined by dual energy x-ray absorptiometry using densitometry equipment (Hologic), at the following regions: lumbar spine, femoral neck, total femur and total body. Appendicular lean mass is calculated as the sum of arms and legs lean soft tissue masses, assuming that all non-fat and non-bone tissue is skeletal muscle. The total body fat is expressed in grams and as a percentage of body weight.'}, {'measure': 'Muscle biopsy', 'timeFrame': '4 months of exercise training/testosterone replacement', 'description': 'The muscle biopsy is obtained with a single entry into the muscle 5-10 minutes after administering the local anesthetic following an incision through the skin. A portion of the muscle (\\~10 mg) is processed to evaluate 1) muscle fiber type and 2) cross-sectional area'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if exercise training with or without testosterone replacement can improve cardiopathy in heart failure patients', 'detailedDescription': 'In this study, we are evaluating:\n\n* hospital length of stay and readmission\n* muscle sympathetic nerve activity\n* functional capacity\n* body composition'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* heart failure\n* hypogonadism\n* left ventricular fraction ejection \\< 45%\n\nExclusion Criteria:\n\n* chronic renal failure\n* normal testosterone\n* pace maker'}, 'identificationModule': {'nctId': 'NCT01852994', 'briefTitle': 'Exercise Training and Testosterone Replacement in Heart Failure Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo General Hospital'}, 'officialTitle': 'Exercise Training and Testosterone Replacement in Heart Failure Patients', 'orgStudyIdInfo': {'id': 'Testosterone'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Exercise training', 'description': 'Aerobic and strength exercise training', 'interventionNames': ['Other: Exercise training']}, {'type': 'OTHER', 'label': 'Testosterone replacement', 'description': 'Testosterone replacement will be done quarterly', 'interventionNames': ['Drug: Testosterone replacement']}, {'type': 'OTHER', 'label': 'Testosterone replacement+Exercise', 'description': 'Both Testosterone replacement and Exercise will done', 'interventionNames': ['Drug: Testosterone replacement', 'Other: Exercise training']}], 'interventions': [{'name': 'Testosterone replacement', 'type': 'DRUG', 'otherNames': ['Testosterone Undecylate (Nebido)'], 'description': 'Application quarterly of Testosterone Undecylate', 'armGroupLabels': ['Testosterone replacement', 'Testosterone replacement+Exercise']}, {'name': 'Exercise training', 'type': 'OTHER', 'description': 'Aerobic and strength exercise training', 'armGroupLabels': ['Exercise training', 'Testosterone replacement+Exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05403-900', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Instituto do Coração do Hospital da Clínicas da Universidade de Sao Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Maria Janieire N Alves, MD; PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sao Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}