Gas Exchange for Predicting Hospital Heart Failure Readmissions
NCT ID: NCT01960218
Last Updated: 2014-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
120 participants
OBSERVATIONAL
2013-10-31
2015-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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acute decompensated heart failure
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Subject is hospitalized for acute decompensated heart failure (ADHF)
1. Systolic OR
2. Diastolic
* Subject is Stage C:Class II/III/IV heart failure
* Subject is willing and to provide appropriate informed consent
* Subject is willing and able to comply with the requirements of the protocol, including follow-up evaluations and schedule
* Subject is willing to use the Shape-HF Cardiopulmonary Exercise Testing System
Exclusion Criteria
* Subject is currently participating in another investigational device or drug trial
* Subject is a prisoner, a minor or unable to adequately give informed consent due to mental or physical condition
* Subject is unwilling or unable to return for the required follow-up after test
* Subject has Left Ventricular Assist Device (LVAD)
* Subject is listed for transplant
* 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)
* Subject has a pulmonary embolism (PE) on admission
* Subject is dialysis dependent
* Subject has a cardiac resynchronization device (CRT) which has been re-programmed at any time during the study
* Subject has Chronic Obstructive Pulmonary Disease (COPD) who is oxygen or steroid dependent
* Subject has severe hypertension \> 180 millimeter of mercury (mmHg) resting systolic at time of test
* 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
18 Years
ALL
No
Sponsors
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Shape Medical Systems, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Abraham G Kocheril, MD
Role: PRINCIPAL_INVESTIGATOR
Christie Clinc
Locations
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Veterans Affairs-Washington DC
Washington D.C., District of Columbia, United States
Christie Clinic
Champaign, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Fairview Southdale
Edina, Minnesota, United States
University of Minnesota
Minneapolis, Minnesota, United States
Washington University of Medicine
St Louis, Missouri, United States
Cleveland Clinic
Cleveland, Ohio, United States
Countries
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Facility Contacts
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Jacqueline Gannuscio, DNP, ACNP
Role: primary
Diane Genthner
Role: primary
Aaron Eisman
Role: primary
Ashley Dress
Role: backup
Jennifer Nelson, RN
Role: primary
Jennifer Nelson, RN
Role: primary
Jessica Biondo, RN
Role: primary
Ellen Slifcak, BA, RN
Role: primary
References
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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.
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.
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.
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.
Other Identifiers
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0512
Identifier Type: -
Identifier Source: org_study_id
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