Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2026-02-28 @ 2:30 PM
Study NCT ID:
NCT02340702
Status:
WITHDRAWN
Last Update Posted:
2020-03-11
First Post:
2015-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chronic Obstructive Pulmonary Disease (COPD) in Patients Hospitalized for Acute Decompensated Heart Failure.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004194', 'term': 'Disease'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'targetDuration': '5 Weeks', 'patientRegistry': True}, 'statusModule': {'whyStopped': 'Unable to abstract pulmonary function and some other data from medical records.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2017-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-09', 'studyFirstSubmitDate': '2015-01-07', 'studyFirstSubmitQcDate': '2015-01-13', 'lastUpdatePostDateStruct': {'date': '2020-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-01-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'In-hospital mortality', 'timeFrame': 'Average of 5-weeks', 'description': 'Participants would be followed for the duration of hospital stay'}], 'secondaryOutcomes': [{'measure': 'Length of hospital stay', 'timeFrame': 'Average of 5-weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['COPD and heart failure'], 'conditions': ['Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'The presence of chronic obstructive pulmonary disease (COPD) would confer increased in-hospital mortality and length of hospital stay in patients with acute decompensated heart failure Assess the (1) prevalence of COPD in patients who are hospitalized for acute decompensated heart failure and (2) the association between COPD and in-hospital mortality or length of stay in this cohort.', 'detailedDescription': 'Background:\n\nThe prevalence of mild to moderate COPD is \\~5%-10% with one-year mortality around 3% while heart failure affects is1%-3% with one year mortality 5-7% in the community. The mortality of COPD and heart failure dramatically increase following hospitalization.\n\nHeart failure and COPD are independent predictors of increased morbidity and mortality. COPD and heart failure frequently co-exist in an individual patient through the shared risk factors. The prevalence of COPD in heart failure patient-population and vice verse varies widely according to patient-selection and age of the population. Estimates suggest that COPD is present in 10-40% of the patients with heart failure. Conversely, unrecognized heart failure is identified in approximately 20% of the patient with COPD. The impact of COPD on clinical outcome in patients with acute decompensated heart failure is unclear.\n\nMethods:\n\nThis is an observational cohort study. Per national registry, acute heart failure is defined as either new onset heart failure or decompensation of chronic established heart failure with symptoms sufficient to warrant hospitalization.\n\nThe data related to the following variables would be collected:\n\nage, gender, severity of heart failure (mild, moderate, and severe prior to admission), presence of dyspnea, peripheral edema, crackles, systolic and diastolic blood pressure (on admission and on discharge), heart rate (on admission and on discharge), oxygen saturation (on admission and discharge), blood urea nitrogen (on admission and discharge), serum creatinine (on admission and discharge), serum sodium (on admission and discharge), hemoglobin (on admission and discharge), red cell distribution width (on admission and discharge), electrocardiographic intervals (on admission and discharge), comorbidities (coronary artery disease, chronic kidney disease, atrial fibrillation, diabetes, hypertension, dyslipidemia, peripheral artery disease, COPD/asthma, left ventricular ejection fraction \\>40%. Medication use: angiotensin converting enzyme inhibitors, angiotensin receptor blockers, aspirin, metoprolol tartrate, metoprolol succinate, carvedilol, atenolol, amlodipine, Cardizem, clopidogrel, digoxin, diuretics, statins, nitrates, warfarin, non-steroidal anti-inflammatory drugs, hydralazine.\n\nEnd-points:\n\n1\\) All cause in-hospital death and 2) length of hospital stay between heart failure patients with COPD and those with no COPD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients hospitalized for acute decompensated heart Failure', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Heart failure\n\nExclusion Criteria:\n\n* Ambulatory patients'}, 'identificationModule': {'nctId': 'NCT02340702', 'acronym': 'COPD', 'briefTitle': 'Chronic Obstructive Pulmonary Disease (COPD) in Patients Hospitalized for Acute Decompensated Heart Failure.', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'COPD in Patients Hospitalized for Acute Decompensated Heart Failure.', 'orgStudyIdInfo': {'id': '14-006196'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patient with COPD and those without COPD', 'description': 'The participants of acute decompensated heart failure national registry would be stratified in to two group: those with COPD and those without COPD, to determine prognostic implication of COPD in participants with acute decompensated heart failure', 'interventionNames': ['Other: COPD']}], 'interventions': [{'name': 'COPD', 'type': 'OTHER', 'otherNames': ['chronic obstructive pulmonary disease'], 'description': 'COPD as diagnosed clinically or based on pulmonary function test showing post-bronchodilator forced expiratory volume in one second to forced vital capacity ratio of \\<0.7.', 'armGroupLabels': ['Patient with COPD and those without COPD']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PI', 'investigatorFullName': 'Mohammed Yousufuddin, M.D', 'investigatorAffiliation': 'Mayo Clinic'}}}}