Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2026-01-16 @ 10:13 AM
Study NCT ID:
NCT02696005
Status:
UNKNOWN
Last Update Posted:
2016-03-02
First Post:
2015-12-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hormone KLOTHO Level in Heart Failure Patients That Participate in Rehabilitation Programme
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2017-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-02-25', 'studyFirstSubmitDate': '2015-12-30', 'studyFirstSubmitQcDate': '2016-02-25', 'lastUpdatePostDateStruct': {'date': '2016-03-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-03-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum Klotho hormone level', 'timeFrame': '"Baseline", "3 months" and "6 months"', 'description': 'Change in serum Klotho level between "Baseline", "3 months" and "6 months" visits'}], 'secondaryOutcomes': [{'measure': 'Incidence of Hospital Readmissions in patients with different serum level of KLOTHO', 'timeFrame': '"3 months" and "6 months" and "1 Year"'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': '30 patients suffering from Heart Failure with Ejection Fraction less than 40% start Cardiac Rehabilitation Programme, serum KLOTHO Hormone level and other labs and Echo measurements will be taken on the first visit.\n\nAfter completion of 3-month Rehabilitation Programme the second set of labs and Echo measurements will be taken.\n\nThan participants will be divided for 2 groups: the patients who wish to continue Rehabilitation programme for additional 3-month period and the second group that prefer to stop Rehabilitation programme after completion of the first 3 month period.\n\nFor both groups additional set of labs will be taken this time and at the end of the study.\n\nThe Aim of the study: to investigate association between serum KLOTHO level, physical activity and possible correlation with laboratory and echocardiographic parameters in cohort of Heart Failure patients.', 'detailedDescription': '30 patients, age range older than 18 years old suffering from Heart Failure, Functional capacity II-III and echocardiographic evidence of Left Ventricular Ejection Fraction less than 40% beginning Cardiac Rehabilitation Programme. Following recruitment of patients to the study each one will undergo serum KLOTHO Hormone level assessment along with kidney functions, N terminal -Pro B-Type Natriuretic Peptide hormone activity and Echo measurements .\n\nAfter completion of 3-months Exercise based Rehabilitation Programme set at 70-80% of maximal individual exercise capacity,a second identical set of lab tests and Echo measurements will be performed.\n\nAfter than participants will be divided into 2 groups: Group I will comprise patients who wish to continue Rehabilitation programme for additional 3-months period and the Group II those who will stop Exercise Rehabilitation programme following completion of the first 3 months.\n\nBoth groups will undergo additional set of lab tests at this six-months-point. Except for the primary and secondary end-points all possible correlations between serum KLOTHO level and age, sex, Ejection Fraction, functional capacity, N terminal -Pro B-Type Natriuretic Peptide hormone activity hormone level and kidney function indices will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '30 patients suffering from Heart Failure and beginning Rehabilitation Programme', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Both genders\n2. Patients ≥ than 18 years\n3. Ejection Fraction ≤ than 40 %\n\nExclusion Criteria:\n\n1. Myocardial Infarction ≤ than 1.5 month before inclusion\n2. Renal failure with Creatinine ≥ 1.5 mg/dl\n3. Known Inflammatory condition.\n4. Patient taking Calcium Supplement,Vitamin D or pyrophosphate.'}, 'identificationModule': {'nctId': 'NCT02696005', 'briefTitle': 'Hormone KLOTHO Level in Heart Failure Patients That Participate in Rehabilitation Programme', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bnai Zion Medical Center'}, 'officialTitle': 'Hormone KLOTHO Level in Heart Failure Patients That Participate in Rehabilitation Programme', 'orgStudyIdInfo': {'id': '109-15-BNZ'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group I', 'description': '15 patients who will continue participation in Exercise- Based Cardiac Rehabilitation Programme after completion initial 3-months period.', 'interventionNames': ['Other: Exercise- Based Cardiac Rehabilitation Programme']}, {'label': 'Group II', 'description': '15 patients who will stop participation in Exercise- Based Cardiac Rehabilitation Programme after the initial 3-months period.', 'interventionNames': ['Other: Exercise- Based Cardiac Rehabilitation Programme']}], 'interventions': [{'name': 'Exercise- Based Cardiac Rehabilitation Programme', 'type': 'OTHER', 'otherNames': ['Rehabilitation Programme'], 'description': 'Exercise- Based Cardiac Rehabilitation Programme for patients suffering from Heart Failure.', 'armGroupLabels': ['Group I', 'Group II']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Eugeny Radzishevsky, MD', 'role': 'CONTACT', 'email': 'eradzish@gmail.com', 'phone': '9724835394'}, {'name': 'Ehud Goldhammer, Prof', 'role': 'CONTACT', 'email': 'ehud.goldhammer@b-zion.org.il', 'phone': '9724835394'}], 'overallOfficials': [{'name': 'Eugeny Radzishevsky, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bnai Zion Medical Center- Ministry of Health, Israel'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bnai Zion Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}