Ignite Creation Date:
2025-12-24 @ 1:21 PM
Ignite Modification Date:
2025-12-29 @ 9:41 PM
Study NCT ID:
NCT01671995
Status:
COMPLETED
Last Update Posted:
2012-08-24
First Post:
2012-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimising Congestive Heart Failure Outpatient Clinic Project
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 208}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1996-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2001-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-21', 'studyFirstSubmitDate': '2012-08-19', 'studyFirstSubmitQcDate': '2012-08-21', 'lastUpdatePostDateStruct': {'date': '2012-08-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2001-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of life', 'timeFrame': '18 months', 'description': 'Nottingham health profile used for quality of life assessment'}], 'secondaryOutcomes': [{'measure': 'Hospitalizations', 'timeFrame': '18 months', 'description': 'Registry data that cover all hospitalizations for all patients'}, {'measure': 'Evaluation of heart failure medication', 'timeFrame': '18 months', 'description': 'Whether patients receive appropriate drug therapy (drug classes) and reach target doses of heart failure medication'}, {'measure': 'Mortality', 'timeFrame': '18 months', 'description': 'Mortality from death certificates obtained.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Heart failure', 'Quality of life'], 'conditions': ['Heart Failure']}, 'referencesModule': {'references': [{'pmid': '15310688', 'type': 'RESULT', 'citation': 'Mejhert M, Kahan T, Persson H, Edner M. Limited long term effects of a management programme for heart failure. Heart. 2004 Sep;90(9):1010-5. doi: 10.1136/hrt.2003.014407.'}, {'pmid': '12181213', 'type': 'RESULT', 'citation': 'Mejhert M, Linder-Klingsell E, Edner M, Kahan T, Persson H. Ventilatory variables are strong prognostic markers in elderly patients with heart failure. Heart. 2002 Sep;88(3):239-43. doi: 10.1136/heart.88.3.239.'}, {'pmid': '16213040', 'type': 'RESULT', 'citation': 'Mejhert M, Kahan T, Persson H, Edner M. Predicting readmissions and cardiovascular events in heart failure patients. Int J Cardiol. 2006 Apr 28;109(1):108-13. doi: 10.1016/j.ijcard.2005.07.015. Epub 2005 Oct 5.'}, {'pmid': '18338962', 'type': 'RESULT', 'citation': 'Mejhert M, Kahan T, Edner M, Persson HE. Sex differences in systolic heart failure in the elderly: the prognostic importance of left ventricular mass in women. J Womens Health (Larchmt). 2008 Apr;17(3):373-81. doi: 10.1089/jwh.2007.0487.'}]}, 'descriptionModule': {'briefSummary': 'This study examines whether a nurse monitored management program at the hospital heart failure outpatient clinic can improve quality of life in elderly patients with chronic heart failure, as compared to standard treatment in primary healthcare.', 'detailedDescription': 'Patients 60 years of age or more hospitalized with heart failure according to New York Heart Association (NYHA) class II-IV and systolic dysfunction (left ventricular ejection fraction less than 0.45) are investigated before discharge and than randomized to the nurse monitored management program or to standard care. Examinations are performed at 0, 6, 12, and 18 months, and include clinical signs and symptoms, quality of life, biochemical assessment, echocardiography and drugs used. The study will be completed when all patients have passed the 18 month follow up examination. Quality of life is assessed by the Nottingham health profile.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients 60 years of age or older\n* Hospitalized with heart failure according to New York Heart Association (NYHA) class II-IV\n* Left ventricular systolic dysfunction with an ejection fraction below 0.45, by echocardiography\n\nExclusion Criteria:\n\n* An acute myocardial infarction or unstable angina pectoris within the last three months\n* Valvular stenosis\n* Dementia\n* Severe concomitant disease\n* Refusal to participate.'}, 'identificationModule': {'nctId': 'NCT01671995', 'acronym': 'OPTIMAL', 'briefTitle': 'Optimising Congestive Heart Failure Outpatient Clinic Project', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Optimising Congestive Heart Failure Outpatient Clinic Project (OPTIMAL)', 'orgStudyIdInfo': {'id': 'OPTIMAL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nurse monitored heart failure program', 'description': 'To assess whether a nurse monitored management programme at the hospital outpatient clinic would improve quality of life, as compared to standard primary health care.', 'interventionNames': ['Procedure: Nurse monitored heart failure program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard primary health care', 'description': 'To assess whether a nurse monitored management programme at the hospital outpatient clinic would improve quality of life, as compared to standard primary health care.', 'interventionNames': ['Procedure: Standard primary health care']}], 'interventions': [{'name': 'Nurse monitored heart failure program', 'type': 'PROCEDURE', 'description': 'Standard program for a heart failure clinic with information, education, drug titration', 'armGroupLabels': ['Nurse monitored heart failure program']}, {'name': 'Standard primary health care', 'type': 'PROCEDURE', 'description': 'Standard care in primary care according to national guidelines but at the discretion of the primary care caregiver', 'armGroupLabels': ['Standard primary health care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '182 88', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Danderyd University Hospital Corp', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Magnus Edner, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Karolinska Institutet'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'collaborators': [{'name': 'Region Stockholm', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Thomas Kahan', 'investigatorAffiliation': 'Karolinska Institutet'}}}}