Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2026-01-08 @ 4:34 AM
Study NCT ID:
NCT01960218
Status:
UNKNOWN
Last Update Posted:
2014-04-04
First Post:
2013-10-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gas Exchange for Predicting Hospital Heart Failure Readmissions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004417', 'term': 'Dyspnea'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2015-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-04-03', 'studyFirstSubmitDate': '2013-10-04', 'studyFirstSubmitQcDate': '2013-10-08', 'lastUpdatePostDateStruct': {'date': '2014-04-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '1. To evaluate if exercise gas exchange tests can predict 30 day hospital readmission for heart failure.', 'timeFrame': '30 days ± 3 days post discharge', 'description': 'The analysis of exercise gas exchange (using the Shape-HF Cardiopulmonary Exercise Testing System) of the incidence of hospital readmission through 30 days ± 3 days post discharge follow-up.'}, {'measure': '2. To evaluate which gas exchange patterns were most highly associated with 30 day risk of readmission for recurrent acute decompensated heart failure.', 'timeFrame': '30 days ± 3 days post discharge', 'description': 'The analysis of exercise gas exchange (using the Shape-HF Cardiopulmonary Exercise Testing System) of the incidence of hospital readmission through 30 days ± 3 days post discharge follow-up.'}, {'measure': '3. To determine the incidence of Adverse Events (AE) and Serious Adverse Events (SAE).', 'timeFrame': '30 days ± 3 days post discharge follow-up and through 180 days ± 15 days post discharge', 'description': 'The analysis of the incidence of AEs and SAEs on the day of discharge post Shape-HF Cardiopulmonary Exercise Testing System through 30 days ± 3 days post discharge follow-up and through 180 days ± 15 days post discharge follow-up.'}], 'secondaryOutcomes': [{'measure': '1. To evaluate if exercise gas exchange tests can predict 180 day hospital readmission for heart failure.', 'timeFrame': '180 days ± 15 days post discharge', 'description': 'The analysis of exercise gas exchange (using the Shape-HF Cardiopulmonary Exercise Testing System) of the incidence of hospital readmission through 180 days ± 15 days post discharge follow-up.'}, {'measure': '2. To evaluate which gas exchange patterns were most highly associated with 180 day risk of readmission for recurrent acute decompensated heart failure.', 'timeFrame': '180 days ± 15 days post discharge', 'description': 'The analysis of exercise gas exchange (using the Shape-HF Cardiopulmonary Exercise Testing System) of the incidence of hospital readmission through 180 days ± 15 days post discharge follow-up.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['acute decompensated heart failure', 'gas exchange', 'cardiopulmonary', 'dyspnea', 'cardiopulmonary analyzer', 'heart disease', 'cardiovascular disease', 'cardiopulmonary exercise'], 'conditions': ['Acute Decompensated Heart Failure']}, 'referencesModule': {'references': [{'pmid': '18672162', 'type': 'BACKGROUND', 'citation': 'Fang J, Mensah GA, Croft JB, Keenan NL. Heart failure-related hospitalization in the U.S., 1979 to 2004. J Am Coll Cardiol. 2008 Aug 5;52(6):428-34. doi: 10.1016/j.jacc.2008.03.061.'}, {'pmid': '11773911', 'type': 'BACKGROUND', 'citation': 'Pulignano G, Del Sindaco D, Tavazzi L, Lucci D, Gorini M, Leggio F, Porcu M, Scherillo M, Opasich C, Di Lenarda A, Senni M, Maggioni AP; IN-CHF Investigators. Clinical features and outcomes of elderly outpatients with heart failure followed up in hospital cardiology units: data from a large nationwide cardiology database (IN-CHF Registry). Am Heart J. 2002 Jan;143(1):45-55. doi: 10.1067/mhj.2002.119608.'}, {'pmid': '21164330', 'type': 'BACKGROUND', 'citation': 'Jacobs B. Reducing heart failure hospital readmissions from skilled nursing facilities. Prof Case Manag. 2011 Jan-Feb;16(1):18-24; quiz 25-6. doi: 10.1097/NCM.0b013e3181f3f684.'}, {'pmid': '16061743', 'type': 'BACKGROUND', 'citation': 'Yu CM, Wang L, Chau E, Chan RH, Kong SL, Tang MO, Christensen J, Stadler RW, Lau CP. Intrathoracic impedance monitoring in patients with heart failure: correlation with fluid status and feasibility of early warning preceding hospitalization. Circulation. 2005 Aug 9;112(6):841-8. doi: 10.1161/CIRCULATIONAHA.104.492207. Epub 2005 Aug 1.'}]}, 'descriptionModule': {'briefSummary': 'To determine whether, and if so, which gas exchange parameters measured on the Shape-HF Cardiopulmonary Exercise Testing System predict 30 and 180 day re-hospitalization in subjects discharged from hospitalization for an episode of acute decompensated heart failure.', 'detailedDescription': "This is a prospective, single-specialty clinical study. This study is intended to evaluate the select gas exchange parameters during a short, sub-max bout of exercise using a simple stationary step on day of discharge to predict the subjects' readmission for acute decompensated heart failure."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects will be consecutively recruited from the population of subjects admitted to the hospital with acute decompensated heart failure.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject is 18 Years and older\n* Subject is hospitalized for acute decompensated heart failure (ADHF)\n\n 1. Systolic OR\n 2. Diastolic\n* Subject is Stage C:Class II/III/IV heart failure\n* Subject is willing and to provide appropriate informed consent\n* Subject is willing and able to comply with the requirements of the protocol, including follow-up evaluations and schedule\n* Subject is willing to use the Shape-HF Cardiopulmonary Exercise Testing System\n\nExclusion Criteria:\n\n* The subject is pregnant (verified in a manner consistent with institution's standard of care)\n* Subject is currently participating in another investigational device or drug trial\n* Subject is a prisoner, a minor or unable to adequately give informed consent due to mental or physical condition\n* Subject is unwilling or unable to return for the required follow-up after test\n* Subject has Left Ventricular Assist Device (LVAD)\n* Subject is listed for transplant\n* Subject has a clinical diagnosis of acute myocardial infarction (AMI) on admission (Note: If troponin measurements have been collected and are elevated but not due to an MI subject is still eligible for study)\n* Subject has a pulmonary embolism (PE) on admission\n* Subject is dialysis dependent\n* Subject has a cardiac resynchronization device (CRT) which has been re-programmed at any time during the study\n* Subject has Chronic Obstructive Pulmonary Disease (COPD) who is oxygen or steroid dependent\n* Subject has severe hypertension \\> 180 millimeter of mercury (mmHg) resting systolic at time of test\n* Subject has severe heart failure with renal insufficiency (with Creatinine clearance rate (CrCL) of 30 or less) and/or on IV Inotropic therapy and/or enrolling in hospice"}, 'identificationModule': {'nctId': 'NCT01960218', 'briefTitle': 'Gas Exchange for Predicting Hospital Heart Failure Readmissions', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shape Medical Systems, Inc.'}, 'officialTitle': 'Gas Exchange for Predicting Hospital Heart Failure Readmissions Clinical Evaluation Study', 'orgStudyIdInfo': {'id': '0512'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'acute decompensated heart failure', 'description': 'Adult subjects anticipating discharge from a hospitalization where the primary discharge diagnosis is acute decompensated heart failure and who are not excluded due to existing conditions.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20422', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jacqueline Gannuscio, DNP, ACNP', 'role': 'CONTACT', 'phone': '202-745-8000', 'phoneExt': '7297'}, {'name': 'Jacqueline Gannuscio, DNP, ACNP', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Veterans Affairs-Washington DC', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '61820', 'city': 'Champaign', 'state': 'Illinois', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Diane Genthner', 'role': 'CONTACT', 'phone': '217-337-2221'}, {'name': 'Abraham G Kocheril, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Christie Clinic', 'geoPoint': {'lat': 40.11642, 'lon': -88.24338}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Aaron Eisman', 'role': 'CONTACT', 'phone': '617-643-1697'}, {'name': 'Ashley Dress', 'role': 'CONTACT', 'phone': '617.643.1697'}, {'name': 'Gregory Lewis, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55435', 'city': 'Edina', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jennifer Nelson, RN', 'role': 'CONTACT', 'phone': '612-625-9455'}, {'name': 'Eric Ernst, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fairview Southdale', 'geoPoint': {'lat': 44.88969, 'lon': -93.34995}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jennifer Nelson, RN', 'role': 'CONTACT', 'phone': '612-625-0455'}, {'name': 'Peter Eckman, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jessica Biondo, RN', 'role': 'CONTACT', 'phone': '314-286-1767'}, {'name': 'Gregory A Ewald, MD, FACC', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Washington University of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ellen Slifcak, BA, RN', 'role': 'CONTACT', 'phone': '216-445-1776'}, {'name': 'Nancy Albert, PhD., R.N.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Abraham G Kocheril, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Christie Clinc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shape Medical Systems, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}