Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2026-01-24 @ 12:56 PM
Study NCT ID:
NCT01700218
Status:
UNKNOWN
Last Update Posted:
2014-11-25
First Post:
2012-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Integrated Telemonitoring and Nurse Support Evaluation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 350}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2015-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-11-23', 'studyFirstSubmitDate': '2012-10-02', 'studyFirstSubmitQcDate': '2012-10-02', 'lastUpdatePostDateStruct': {'date': '2014-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'exploratory endpoint', 'timeFrame': '12 months', 'description': 'The exploratory endpoint will focus on the percentage of optimal dosing (according to current ESC-guidelines) for ACE-inhibitors, angiotensin receptor blockers and beta-blockers'}], 'primaryOutcomes': [{'measure': 'all cause mortality and hospitalization for worsening heart failure', 'timeFrame': '12 months', 'description': 'outcome assessment will be done by a blinded committee'}], 'secondaryOutcomes': [{'measure': 'days alive and out of hospital', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['telemonitoring'], 'conditions': ['Chronic Heart Failure']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to test a new medical device for optimizing treatment of heart failure and compare its effect on outcome of patients with a recent hospitalization for worsening heart failure', 'detailedDescription': 'Patients after an episode of acute heart failure have an increased risk of rehospitalisation and impaired prognosis for survival. Neither a sole mobile nurse support nor a sole telemonitoring system has been able to provide consistent data on a beneficial influence on prognosis. Furthermore, the influence of frequent measurements of NT-pro-BNP in a home setting of heart failure patients has not been investigated so far.\n\nThis study will test a new medical device (software) for optimizing treatment of heart failure patients and evaluate its impact on outcome of these patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* acute systolic heart failure with admission for at least 4 consecutive days\n* treatment with an ACE-inhibitor/angiotensin receptor blocker, beta-blocker, mineralocorticoid receptor antagonist according to current ESC-guidelines\n* treatment with a loop diuretic\n* stable renal function (eGFR according to MDRD of at least 30ml)\n* written informed consent\n* minimum age of 18 years\n\nExclusion Criteria:\n\n* unstable coronary artery disease with revascularisation of any type within the last two months\n* planned revascularisation or operation for valvular heart disease within the next 6 months\n* planned heart transplantation\n* uncontrolled hypertension\n* active myocarditis\n* malignant disease with a life expectancy of less than 18 months\n* chronic use of high-dose NSAID or COX-2-inhibitors\n* psychiatric disorders that make it unlikely to understand the protocol\n* participation in an other randomized trial\n* inability to operate a smartphone'}, 'identificationModule': {'nctId': 'NCT01700218', 'acronym': 'INTENSE-HF', 'briefTitle': 'Integrated Telemonitoring and Nurse Support Evaluation', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Graz'}, 'officialTitle': 'Integrated Telemonitoring and Nurse Support Evaluation in Heart Failure', 'orgStudyIdInfo': {'id': '24-537 ex 11/12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'telemonitoring', 'description': 'patients in the telemonitoring arm will record vital parameters (blood pressure, heart rate, body weight) and transmit these parameters together with wellbeing and daily dose of heart failure medication', 'interventionNames': ['Other: telemonitoring']}, {'type': 'OTHER', 'label': 'control', 'description': 'patients in the control arm will not record any vital parameter', 'interventionNames': ['Other: control']}], 'interventions': [{'name': 'telemonitoring', 'type': 'OTHER', 'armGroupLabels': ['telemonitoring']}, {'name': 'control', 'type': 'OTHER', 'armGroupLabels': ['control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8036', 'city': 'Graz', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Friedrich M Fruhwald, MD', 'role': 'CONTACT', 'email': 'friedrich.fruhwald@medunigraz.at', 'phone': '+43-316-385', 'phoneExt': '12544'}, {'name': 'Daniel Scherr, MD', 'role': 'CONTACT', 'email': 'daniel.scherr@medunigraz.at', 'phone': '+43-316-385', 'phoneExt': '12544'}, {'name': 'Friedrich M Fruhwald, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Daniel Scherr, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Medical University', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}], 'centralContacts': [{'name': 'Friedrich M Fruhwald, MD', 'role': 'CONTACT', 'email': 'friedrich.fruhwald@medunigraz.at', 'phone': '+43-316-385', 'phoneExt': '12544'}, {'name': 'Daniel Scherr, MD', 'role': 'CONTACT', 'email': 'daniel.scherr@medunigraz.at', 'phone': '+43-316-385', 'phoneExt': '12544'}], 'overallOfficials': [{'name': 'Friedrich M Fruhwald, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Graz'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Graz', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ludwig Boltzmann Institute for translational heart failure research', 'class': 'UNKNOWN'}, {'name': 'AIT Austrian Institute of Technology GmbH', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}