Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2026-01-07 @ 9:16 PM
Study NCT ID:
NCT00591760
Status:
COMPLETED
Last Update Posted:
2012-11-19
First Post:
2007-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Growth Hormone Deficiency in Chronic Heart Failure: A Preliminary Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D004393', 'term': 'Dwarfism, Pituitary'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D004392', 'term': 'Dwarfism'}, {'id': 'D001848', 'term': 'Bone Diseases, Developmental'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D001849', 'term': 'Bone Diseases, Endocrine'}, {'id': 'D007018', 'term': 'Hypopituitarism'}, {'id': 'D010900', 'term': 'Pituitary Diseases'}, {'id': 'D007027', 'term': 'Hypothalamic Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013006', 'term': 'Growth Hormone'}, {'id': 'D019382', 'term': 'Human Growth Hormone'}], 'ancestors': [{'id': 'D010908', 'term': 'Pituitary Hormones, Anterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'antonio.cittadini@unina.it', 'phone': '0039(0)817464375', 'title': 'Prof. Antonio Cittadini', 'organization': 'Federico II University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'GH Replacement Therapy', 'description': 'Patients will receive 6 months of substitutive somatotropin (growth hormone) therapy at a dose of 0,00415 mg/kg a day, added to their background optimized CHF therapy', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'Optimal CHF treatment', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Peak VO2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GH Replacement Therapy', 'description': 'Patients will receive 6 months of substitutive somatotropin (growth hormone) therapy at a dose of 0,00415 mg/kg a day, added to their background optimized CHF therapy'}, {'id': 'OG001', 'title': 'Control', 'description': 'Optimal CHF treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '14.5', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '12.9', 'spread': '1.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'changes in peak VO2', 'unitOfMeasure': 'ml/kg/min', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'GH Replacement Therapy', 'description': 'Patients will receive 6 months of substitutive somatotropin (growth hormone) therapy at a dose of 0,00415 mg/kg a day, added to their background optimized CHF therapy'}, {'id': 'FG001', 'title': 'Control', 'description': 'Optimal CHF treatment'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Sixty-three patients with CHF NYHA class II-IV and GH deficiency were enrolled from December 2004 to December 2006. These patients were consecutively selected from a cohort of 158 ambulatory patients referred to our tertiary care center and, to a minor extent, patients hospitalized for CHF.', 'preAssignmentDetails': 'Patients recruited during hospital stay were studied after a 3-months period of optimized medical therapy and clinical stability'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'GH Replacement Therapy', 'description': 'Patients will receive 6 months of substitutive somatotropin (growth hormone) therapy at a dose of 0,00415 mg/kg a day, added to their background optimized CHF therapy'}, {'id': 'BG001', 'title': 'Control', 'description': 'Optimal CHF treatment'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0.0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '32.0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '24.0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62', 'spread': '6', 'groupId': 'BG000'}, {'value': '62', 'spread': '8', 'groupId': 'BG001'}, {'value': '62', 'spread': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9.0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '47.0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'echocardiography', 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000', 'lowerLimit': '20', 'upperLimit': '70'}, {'value': '40', 'groupId': 'BG001', 'lowerLimit': '20', 'upperLimit': '70'}, {'value': '35', 'groupId': 'BG002', 'lowerLimit': '20', 'upperLimit': '70'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '% of ejection fraction', 'dispersionType': 'FULL_RANGE'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-17', 'studyFirstSubmitDate': '2007-12-20', 'resultsFirstSubmitDate': '2009-03-23', 'studyFirstSubmitQcDate': '2007-12-27', 'lastUpdatePostDateStruct': {'date': '2012-11-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-10-17', 'studyFirstPostDateStruct': {'date': '2008-01-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-11-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peak VO2', 'timeFrame': '6 months', 'description': 'changes in peak VO2'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Heart Failure', 'Growth Hormone', 'Anabolism', 'Anabolic Deficiency', 'Hormone replacement'], 'conditions': ['Heart Failure', 'Growth Hormone Deficiency', 'Ischemic Heart Disease']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the potential benefits of the correction of growth hormone (GH) deficiency with GH replacement therapy in patients with chronic heart failure due to left ventricular systolic dysfunction.', 'detailedDescription': 'To date, a wide range of alterations in the GH/IGF-1 axis have been described in patients with chronic heart failure (CHF): reductions in GH levels, reductions in IGF-1 and a pattern of peripheral resistance to GH, in particular in patients with severe heart failure and cardiac cachexia. Unpublished experience of our group support the concept that a considerable amount of CHF-patients have a coexisting Growth Hormone Deficiency (GHD), defined by current guidelines(GH stimulation test).\n\nOur study hypothesis is that correction of GH deficiency in patients with chronic heart failure may exert a beneficial effect on their cardiac function and remodeling, performance status and quality-of-life.\n\nSince this was a preliminary study, no sample size calculation was performed; treatment effects from were sought in left ventricular function (as assessed by cardiac MRI), cardiopulmonary exercise performance, clinical status, vascular reactivity, biochemistry and neurohumoral markers of disease (NT-proBNP).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Heart Failure in ew York Heart Association functional class II to IV\n* Left ventricular end diastolic diameter \\> 60 mm\n* Left ventricular ejection fraction \\< 40%\n* Growth Hormone Deficiency (defined as a peak GH response to intravenous stimulation with GHRH + Arginine \\< 9 ng/dl)\n* Age 18-80 years\n* Clinical stability, guideline-oriented maximal pharmacological therapy\n* Informed consent\n\nExclusion Criteria:\n\n* Active Myocarditis\n* Hypertrophic Cardiomyopathy\n* Active endocarditis\n* Active malignancy\n* End stage renal disease\n* Severe liver disease (Child B-C)'}, 'identificationModule': {'nctId': 'NCT00591760', 'briefTitle': 'Growth Hormone Deficiency in Chronic Heart Failure: A Preliminary Trial', 'organization': {'class': 'OTHER', 'fullName': 'Federico II University'}, 'officialTitle': 'Correction of Growth Hormone Deficiency in Patients With Chronic Heart Failure: a Randomized, Controlled, Single-blind Study', 'orgStudyIdInfo': {'id': 'GH replacement in CHF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GH', 'description': 'Patients will receive 6 months of substitutive somatotropin (growth hormone) therapy at a dose of 0.012 mg/kg every second day, added to their background optimized CHF therapy', 'interventionNames': ['Drug: Somatotropin']}, {'type': 'NO_INTERVENTION', 'label': 'Placebo', 'description': 'PLacebo will be admistred with the same devices of GH, also on top of Optimal CHF treatment'}], 'interventions': [{'name': 'Somatotropin', 'type': 'DRUG', 'otherNames': ['rhGH', 'Saizen', 'NutropinAq'], 'description': 'Subcutaneous Somatotropin (recombinant human Growth Hormone) 0.012 mg/kg every second day for 6 months', 'armGroupLabels': ['GH']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Antonio Cittadini, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federico II University - Naples'}, {'name': 'Luigi Saccà, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Federico II University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federico II University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Antonio Cittadini', 'oldOrganization': 'Federico II University'}}}}