Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2026-02-24 @ 5:04 PM
Study NCT ID:
NCT00562692
Status:
TERMINATED
Last Update Posted:
2015-06-25
First Post:
2007-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Natriuretic Peptides in the Treatment of Acutely Decompensated Heart Failure Patient With Obstructive Airways Disease
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020097', 'term': 'Natriuretic Peptide, Brain'}], 'ancestors': [{'id': 'D045265', 'term': 'Natriuretic Peptides'}, {'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'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': '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': 'ACTUAL', 'count': 6}}, 'statusModule': {'whyStopped': 'Recruitment very difficult. Study drug expired so we have stopped the study.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-23', 'studyFirstSubmitDate': '2007-11-21', 'studyFirstSubmitQcDate': '2007-11-21', 'lastUpdatePostDateStruct': {'date': '2015-06-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-11-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To compare the need for and the length of time patients require non invasive ventilation when treated with nesiritide vs placebo.', 'timeFrame': '24 hours'}], 'secondaryOutcomes': [{'measure': 'dyspnoea score respiratory rate FEV1 PEFR requirement for concomitant bronchodilator therapy BNP', 'timeFrame': '24 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Heart failure', 'OAD', 'BNP', 'Heart Failure patients who present to the emergency department'], 'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': "Brain natriuretic peptide (BNP) is a useful therapy when treating patients with heart failure. As many of these patients also have airways disease it is important to determine if BNP also has a positive effect on their respiratory condition. The role of BNP in airways disease has never been studied although there is evidence to suggest that it will have a positive effect.\n\nThe current study is therefore a proof on concept study which will demonstrate whether BNP (nesiritide) will improve both heart failure and airflow obstruction in patient who have both.\n\nThe investigators are looking to enroll 40 patients with heart failure and airways disease who present to hospital emergency departments. Patients who consent and meet the entry criteria will be randomised to receive either nesiritide or placebo in addition to standard therapy. They will receive a bolus of study medication followed by a 4 hour infusion. Before, at hourly intervals and immediately following the infusion the following data will be collected:\n\n* dyspnoea score\n* respiratory rate\n* FEV1 (if able to be performed)\n* peak respiratory flow rates (PEFR, if able to be performed)\n* requirement for concomitant bronchodilator therapy\n* urinary GMP At all times during the study period and at the conclusion of the study patients will be provided with the best available therapy for their condition at the physicians' discretion."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Males and females\n2. Over 18 years of age\n3. Confirmed written informed consent.\n4. Acute decompensated heart failure based on physicians assessment and requiring treatment as per standard emergency department protocols for this condition.\n5. Requirement for intravenous therapy of HF, e.g. diuretic, vasodilator.\n6. COAD based on physician's assessment and requiring treatment as per standard emergency department protocols for this condition. Must have at least 2 of the following criteria:\n\n * history of smoking \\> 20 pack years,\n * prior history of PFTs within last 1 year consistent with COAD,\n * history of chronic cough and sputum production,\n * progressive dyspnea, episodes of acute bronchitis over at least 2 yrs\n\nExclusion Criteria:\n\n1. Women lactating, pregnant or of childbearing potential not using 2 reliable contraceptive methods.\n2. Patients who had received an investigational new drug within the last 4 weeks.\n3. Patients with a history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study.\n4. SBP \\<90mmHg\n5. Creatinine \\>0.25mmol/L\n6. Sp02 \\< 80% on supplemental oxygen or known cor pulmonale with TR"}, 'identificationModule': {'nctId': 'NCT00562692', 'acronym': 'BNP in OAD', 'briefTitle': 'Role of Natriuretic Peptides in the Treatment of Acutely Decompensated Heart Failure Patient With Obstructive Airways Disease', 'organization': {'class': 'OTHER', 'fullName': 'The Alfred'}, 'officialTitle': 'Role of Natriuretic Peptides in the Treatment of Acutely Decompensated Heart Failure Patient With Obstructive Airways Disease', 'orgStudyIdInfo': {'id': 'CP-02/05'}, 'secondaryIdInfos': [{'id': 'Project No. 11/06'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'Nesiritide', 'interventionNames': ['Drug: Nesiritide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'B', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Nesiritide', 'type': 'DRUG', 'description': 'Nesiritide 4 hour infusion', 'armGroupLabels': ['A']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo infusion', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3004', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Alfred Hospital', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}], 'overallOfficials': [{'name': 'Henry Krum, MBBS FRACP PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Monash University / Alfred Hospital'}, {'name': 'Peter Cameron', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Monash University / Alfred Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Alfred', 'class': 'OTHER'}, 'collaborators': [{'name': 'Janssen-Cilag Pty Ltd', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head Clinical Pharmacology', 'investigatorFullName': 'Henry Krum', 'investigatorAffiliation': 'The Alfred'}}}}