Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2026-02-20 @ 6:05 PM
Study NCT ID:
NCT03775993
Status:
UNKNOWN
Last Update Posted:
2019-02-15
First Post:
2018-12-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of GHD Associated With CHF
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D004393', 'term': 'Dwarfism, Pituitary'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019382', 'term': 'Human Growth Hormone'}], 'ancestors': [{'id': 'D013006', 'term': 'Growth Hormone'}, {'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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 64}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2022-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-02-13', 'studyFirstSubmitDate': '2018-12-12', 'studyFirstSubmitQcDate': '2018-12-12', 'lastUpdatePostDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of peak oxygen consumption (peak VO2)', 'timeFrame': '1 year', 'description': 'According to previous observations, the investigators set a target increase of peak VO2 in the treated arm at 3 ml/kg/min at the end of the study'}], 'secondaryOutcomes': [{'measure': 'Number of Hospitalizations', 'timeFrame': '1 year'}, {'measure': 'End-systolic LV volumes', 'timeFrame': '1 year'}, {'measure': 'NT-proBNP levels', 'timeFrame': '1 year'}, {'measure': 'Quality of life score from the Minnesota Living with Heart Failure Questionnaire', 'timeFrame': '1 year', 'description': "The questionnaire is comprised of 21 physical, emotional and socioeconomic questions that may adversely affect a patient's life. After receiving brief standardized instructions, the patient marks a 0 (lower valure) to 5 (upper value) scale to indicate how much each itemized adverse of heart failure has prevented the patient from living as he or she wanted to live during the past 4 weeks. The final score is calculated by sum."}, {'measure': 'Evaluation of Endothelial function (flow-mediated vasodilation)', 'timeFrame': '1 year'}, {'measure': 'Muscle strength (handgrip)', 'timeFrame': '1 year'}, {'measure': 'Evaluation of the Levels of Endothelial Progenitor Cells (EPCs)', 'timeFrame': '1 year'}, {'measure': 'Evaluation of the Levels of lymphocyte G protein-coupled receptor kinase (GRK)-2', 'timeFrame': '1 year'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Growth Hormone', 'Placebo', 'Exercise capacity', 'Vascular reactivity', 'LV function', 'Prognosis'], 'conditions': ['Heart Failure', 'Growth Hormone Deficiency']}, 'referencesModule': {'references': [{'pmid': '40047762', 'type': 'DERIVED', 'citation': "Marra AM, D'Assante R, De Luca M, Arcopinto M, Gargiulo P, Valente V, Crisci G, Rainone C, Modestino M, Giardino F, Paolillo S, Cacciatore F, Saldamarco L, Bruzzese D, Scarpa D, Filardi PP, Esposito G, Sacca L, Bossone E, Salzano A, Cittadini A. Growth Hormone Replacement Therapy in Heart Failure With Reduced Ejection Fraction: A Randomized, Double-Blind, Placebo-Controlled Trial. JACC Heart Fail. 2025 Apr;13(4):602-614. doi: 10.1016/j.jchf.2024.11.017. Epub 2025 Mar 5."}]}, 'descriptionModule': {'briefSummary': 'Aim of the current study is to assess the cardiovascular effects of GH replacement therapy in patients with coexisting GHD and CHF', 'detailedDescription': 'Multiple anabolic deficiencies are common in chronic heart failure (CHF) and identify subgroups of patients with higher mortality. Apart from CHF, GH deficiency (GHD) per se increases cardiovascular mortality in the general population and low IGF-1 levels in the general population predict the development of ischemic heart disease and CHF. GHD modifies cardiac size and function, through a reduction in both myocardial growth and cardiac performance. The investigators therefore completed 2 studies aimed at evaluating the clinical status, neurohormonal parameters, exercise capacity, vascular reactivity, and left ventricular architecture and function in patients with GHD and CHF, at baseline and after 6 months of GH replacement therapy. They subsequently extended the observation period up to 48 months. At 6-months, GH replacement therapy improved clinical status and exercise capacity, as shown by a significant reduction of the Minnesota living with heart failure questionnaire score, increased peak oxygen consumption and exercise duration, and flow mediated vasodilation of the brachial artery. No major adverse events were reported in the patients receiving GH.\n\nHowever, the encouraging results of these studies are limited by the lack of a double-blind, placebo-controlled design, insofar as the investigators performed a randomized controlled, single-blind study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. patients of either sex affected by CHF NYHA class I-III, secondary to ischemic or idiopathic di-lated cardiomyopathy;\n2. age range 18-85 years;\n3. stable and optimal medical therapy for at least three months prior to randomization, including ACE inhibitors or AT1 antagonists and beta-blockers (unless untolerated);\n4. LV ejection fraction 40% or less and LV end-diastolic dimension 55 mm or more;\n5. GH deficiency diagnosed with GHRH + arginine provocative test;\n6. signed informed consent.\n\nExclusion Criteria:\n\n1. inability to perform a bicycle exercise test;\n2. poorly controlled diabetes mellitus (HbA1c \\>8.5) and/or active proliferative or severe non-proliferative diabetic retinopathy;\n3. active and/or history of malignancy;\n4. unstable angina or recent myocardial infarction (less than six months);\n5. severe liver or kidney disease (serum creatinine levels \\>2.5 mg/dl'}, 'identificationModule': {'nctId': 'NCT03775993', 'briefTitle': 'Treatment of GHD Associated With CHF', 'organization': {'class': 'OTHER', 'fullName': 'Federico II University'}, 'officialTitle': 'Treatment of Growth Hormone Deficiency Associated With Chronic Heart Failure: A Randomized, Double-Blind, Placebo-Controlled Study', 'orgStudyIdInfo': {'id': '2016-004580-39'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'GHD', 'interventionNames': ['Drug: Human growth hormone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Human growth hormone', 'type': 'DRUG', 'description': 'Administration of growth hormone', 'armGroupLabels': ['GHD']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Administration of placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Antonio Cittadini, Full Professor of Medicine', 'role': 'CONTACT', 'email': 'cittadin@unina.it', 'phone': '+390817464375'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federico II University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Full Professor', 'investigatorFullName': 'Antonio Cittadini', 'investigatorAffiliation': 'Federico II University'}}}}