Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2025-12-25 @ 9:18 PM
Study NCT ID:
NCT00702156
Status:
TERMINATED
Last Update Posted:
2008-09-03
First Post:
2008-06-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bisoprolol in Patients With Heart Failure and Chronic Obstructive Pulmonary Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017298', 'term': 'Bisoprolol'}], 'ancestors': [{'id': 'D050198', 'term': 'Phenoxypropanolamines'}, {'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'whyStopped': 'Inadequate patient recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-08', 'completionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-09-02', 'studyFirstSubmitDate': '2008-06-19', 'studyFirstSubmitQcDate': '2008-06-19', 'lastUpdatePostDateStruct': {'date': '2008-09-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Forced expiratory volume 1 second (FEV1)', 'timeFrame': '16 weeks'}], 'secondaryOutcomes': [{'measure': 'Quality of life: Minnesota Living with Heart Failure, SF-36', 'timeFrame': '16 weeks'}, {'measure': 'NYHA Class', 'timeFrame': '16 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Heart Failure', 'Chronic Obstructive Pulmonary Disease', 'Beta-blockers', 'Pulmonary Function'], 'conditions': ['Heart Failure', 'Chronic Obstructive Pulmonary Disease']}, 'referencesModule': {'references': [{'pmid': '19460848', 'type': 'DERIVED', 'citation': 'Hawkins NM, MacDonald MR, Petrie MC, Chalmers GW, Carter R, Dunn FG, McMurray JJ. Bisoprolol in patients with heart failure and moderate to severe chronic obstructive pulmonary disease: a randomized controlled trial. Eur J Heart Fail. 2009 Jul;11(7):684-90. doi: 10.1093/eurjhf/hfp066. Epub 2009 May 21.'}]}, 'descriptionModule': {'briefSummary': 'The principal research objectives are to demonstrate cardioselective beta-blockade using bisoprolol is not inferior to placebo with regard to pulmonary function and improves quality of life in patients with heart failure and coexistent moderate or severe chronic obstructive pulmonary disease with or without significant reversibility. Patients will be followed up for 4 months during which bisoprolol will be up-titrated to the maximum clinically tolerated dose. Health status will be assessed using a generic and two disease specific questionnaires, and pulmonary function by spirometry, body box plethysmography, and cardiopulmonary exercise testing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* symptomatic NYHA II or III chronic heart failure\n* left ventricular systolic dysfunction\n* moderate or severe chronic obstructive pulmonary disease\n* with or without significant reversibility\n\nExclusion Criteria:\n\n* beta-blocker contraindications\n* non-dihydropyridine (diltiazem / verapamil) calcium channel blockers\n* recent coronary percutaneous intervention or coronary artery bypass graft surgery\n* haemodynamically significant valvular disease or hypertrophic cardiomyopathy.\n* active myocarditis or pericarditis.\n* recent cerebrovascular accident or transient ischaemic attack\n* serious concurrent systemic disease, such as malignancy, resulting in likely reduced life expectancy\n* pregnancy, childbearing potential with inadequate contraception, breast feeding'}, 'identificationModule': {'nctId': 'NCT00702156', 'briefTitle': 'Bisoprolol in Patients With Heart Failure and Chronic Obstructive Pulmonary Disease', 'organization': {'class': 'OTHER', 'fullName': 'NHS Greater Glasgow and Clyde'}, 'officialTitle': 'Cardioselective Beta-Blockade Using Bisoprolol in Patients With Chronic Heart Failure (CHF) and Coexistent Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) With or Without Significant Reversibility.', 'orgStudyIdInfo': {'id': 'RN05CA013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Bisoprolol', 'interventionNames': ['Drug: Bisoprolol']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Identical appearance matching placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Bisoprolol', 'type': 'DRUG', 'otherNames': ['Bisoprolol Fumarate', 'Brand name: Cardicor'], 'description': 'Titration. 1.25 mg 2 weeks, 2.5 mg 2 weeks, 5 mg 4 weeks, 7.5 mg 4 weeks, 10 mg 4 weeks.', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Titration. 1.25 mg 2 weeks, 2.5 mg 2 weeks, 5 mg 4 weeks, 7.5 mg 4 weeks, 10 mg 4 weeks.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G31 2ER', 'city': 'Glasgow', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Cardiopulmonary Transplant Unit Glasgow Royal Infirmary', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}], 'overallOfficials': [{'name': 'Nathaniel M Hawkins, MBChB', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NHS Greater Glasgow and Clyde'}, {'name': 'Francis G Dunn, MBChB MD', 'role': 'STUDY_CHAIR', 'affiliation': 'NHS Greater Glasgow and Clyde'}, {'name': 'Roger Carter, BSc MSc PHD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'NHS Greater Glasgow and Clyde'}, {'name': 'George W Chalmers, MBChB MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'NHS Greater Glasgow and Clyde'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NHS Greater Glasgow and Clyde', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr Nathaniel Hawkins', 'oldOrganization': 'Glasgow Royal Infirmary'}}}}