Ignite Creation Date:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2026-03-01 @ 4:12 PM
Study NCT ID:
NCT02976350
Status:
COMPLETED
Last Update Posted:
2016-11-29
First Post:
2016-05-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hormone Deficiency in Heart Failure With Preserved Ejection Fraction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D004393', 'term': 'Dwarfism, Pituitary'}, {'id': 'D005067', 'term': 'Euthyroid Sick Syndromes'}], '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': 'D013959', 'term': 'Thyroid Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'serum for determination of hormonal levels'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-23', 'studyFirstSubmitDate': '2016-05-14', 'studyFirstSubmitQcDate': '2016-11-23', 'lastUpdatePostDateStruct': {'date': '2016-11-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-11-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of Hormone deficiency', 'timeFrame': '1 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Heart failure', 'Heart failure with preserved ejection fraction', 'GH deficiency', 'Testosterone deficiency', 'Low- T3 syndrome', 'Multiple Hormone Deficiencies'], 'conditions': ['Heart Failure', 'Hormone Deficiencies']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to describe the prevalence of Multiple Hormone Deficiencies in Heart Failure with preserved Ejection Fraction.', 'detailedDescription': 'Despite the effectiveness of the neurohormonal model to explain the progression of heart failure and the many insights that it provided for the development of new therapies, there is increasing clinical evidence that suggests that our current models fail to completely explain the disease progression. Thus, neurohormonal models may be necessary but not sufficient to explain all aspects of disease progression in the failing heart. There is evidence suggesting that in heart failure there is a metabolic imbalance characterized by the predominance of the catabolic status over the anabolic drive.\n\nConsistent data coming from several independent groups have documented the reduced activity of most anabolic axes in HF with reduced ejection fraction. To date, no study has addressed the prevalence the presence and the prevalence of the Multiple Hormone Deficiencies in Heart Failure with preserved Ejection Fraction.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Male patients with stable chronic heart failure with preserved ejection fraction', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male patients of affected by CHF, secondary to ischemic or idiopathic dilated cardiomyopathy\n* left ventricle ejection fraction \\> 50% or more\n\nExclusion Criteria:\n\n* severe liver disease\n* serum creatinine levels \\>2.5 mg/dl\n* history of active cancer with life expectancy below 1 year acute coronary syndrome in the previous 6 months'}, 'identificationModule': {'nctId': 'NCT02976350', 'acronym': 'MHDS in HFpEF', 'briefTitle': 'Hormone Deficiency in Heart Failure With Preserved Ejection Fraction', 'organization': {'class': 'OTHER', 'fullName': 'Federico II University'}, 'officialTitle': 'Multiple Hormone Deficiency Syndrome in Heart Failure With Preserved Ejection Fraction', 'orgStudyIdInfo': {'id': 'HormoneHFpEF001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with HFpEF', 'description': 'Male patients with heart failure with preserved ejection fraction'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Napoli', 'country': 'Italy', 'facility': 'Antonio Cittadini', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}], 'overallOfficials': [{'name': 'Antonio Cittadini, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Federico II University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federico II University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Antonio Cittadini', 'investigatorAffiliation': 'Federico II University'}}}}