Ignite Creation Date:
2025-12-24 @ 12:49 PM
Ignite Modification Date:
2025-12-28 @ 4:28 AM
Study NCT ID:
NCT01576861
Status:
COMPLETED
Last Update Posted:
2012-10-18
First Post:
2012-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-Term Efficacy and Safety of Growth Hormone Replacement Therapy in Chronic Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004393', 'term': 'Dwarfism, Pituitary'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013006', 'term': '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-17', 'studyFirstSubmitDate': '2012-03-19', 'studyFirstSubmitQcDate': '2012-04-12', 'lastUpdatePostDateStruct': {'date': '2012-10-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peak Oxygen Consumption', 'timeFrame': 'after 48 months'}, {'measure': 'Side effects', 'timeFrame': 'Any side effects recorded after 6,24 and 48 months'}], 'secondaryOutcomes': [{'measure': 'Left Ventricular Ejection Fraction', 'timeFrame': 'after 48 months'}, {'measure': 'Left Ventricular End-Systolic Volume', 'timeFrame': 'after 48 months'}, {'measure': 'Left Ventricular End-Diastolic Volume', 'timeFrame': 'after 48 months'}, {'measure': 'Quality of Life', 'timeFrame': 'after 48 months'}]}, 'conditionsModule': {'conditions': ['Growth Hormone Deficiency', 'Chronic Heart Failure']}, 'descriptionModule': {'briefSummary': 'After the encouraging results of 6 months of Growth Hormone Replacement Therapy in Patients With Chronic Heart Failure and Coexisting Growth Hormone Deficiency (NCT00591760) the investigators wanted to collect data about the long-term efficacy and safety of this kind of therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic Heart Failure New York Heart Association functional class II to IV, secondary to ischemic or idiopathic cardiomyopathy\n* Age range 18-80 years\n* Stable medication for at least one month including beta-blockers that had to be started at least 5 months before entering the study\n* Left Ventricular ejection fraction 40% or less\n* Growth Hormone Deficiency (defined as a peak GH response to intravenous stimulation with GHRH + Arginine \\< 9 ng/ml)\n* Written Informed consent\n\nExclusion Criteria:\n\n* Acute proliferative or severe non-proliferative diabetic retinopathy\n* Active malignancy\n* Evidence of progression or recurrence of an underlying intracranial tumor\n* Unstable Angina or recent myocardial infarction\n* Serum Creatinine levels \\> 2.5 mg/dl\n* Severe liver disease (Child-Pugh B-C)'}, 'identificationModule': {'nctId': 'NCT01576861', 'briefTitle': 'Long-Term Efficacy and Safety of Growth Hormone Replacement Therapy in Chronic Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'Federico II University'}, 'orgStudyIdInfo': {'id': 'Long-Term GH in CHF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GH replacement', 'description': 'Patients will receive 48 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': 'Control CHF patients under optimized CHF therapy'}], 'interventions': [{'name': 'Somatotropin', 'type': 'DRUG', 'description': 'Subcutaneous Somatotropin (recombinant Human Growth Hormone) 0,012 mg/kg every second day', 'armGroupLabels': ['GH replacement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80131', 'city': 'Napoli', 'state': 'Campania', 'country': 'Italy', 'facility': 'Department of Internal Medicine, Cardiovascular and Immunological Sciences', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federico II University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Antonio Cittadini', 'investigatorAffiliation': 'Federico II University'}}}}