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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 1. To evaluate if exercise gas exchange tests can predict 30 day hospital readmission for heart failure. | 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. | 30 days ± 3 days post discharge |
| 2. To evaluate which gas exchange patterns were most highly associated with 30 day risk of readmission for recurrent acute decompensated heart failure. | 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. | 30 days ± 3 days post discharge |
| 3. To determine the incidence of Adverse Events (AE) and Serious Adverse Events (SAE). | 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. | 30 days ± 3 days post discharge follow-up and through 180 days ± 15 days post discharge |
| Measure | Description | Time Frame |
|---|---|---|
| 1. To evaluate if exercise gas exchange tests can predict 180 day hospital readmission for heart failure. | 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. | 180 days ± 15 days post discharge |
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Inclusion Criteria:
Subject is 18 Years and older
Subject is hospitalized for acute decompensated heart failure (ADHF)
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:
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Subjects will be consecutively recruited from the population of subjects admitted to the hospital with acute decompensated heart failure.
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| Name | Affiliation | Role |
|---|---|---|
| Abraham G Kocheril, MD | Christie Clinc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Veterans Affairs-Washington DC | Recruiting | Washington D.C. | District of Columbia | 20422 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18672162 | Background | 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. | |
| 11773911 | Background | 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. |
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| ID | Term |
|---|---|
| D004417 | Dyspnea |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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| 2. To evaluate which gas exchange patterns were most highly associated with 180 day risk of readmission for recurrent acute decompensated heart failure. |
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. |
| 180 days ± 15 days post discharge |
| Christie Clinic | Not yet recruiting | Champaign | Illinois | 61820 | United States |
|
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
|
| Fairview Southdale | Recruiting | Edina | Minnesota | 55435 | United States |
|
| University of Minnesota | Recruiting | Minneapolis | Minnesota | 55455 | United States |
|
| Washington University of Medicine | Recruiting | St Louis | Missouri | 63110 | United States |
|
| Cleveland Clinic | Recruiting | Cleveland | Ohio | 44195 | United States |
|
| 21164330 | Background | 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. |
| 16061743 | Background | 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. |
| D013568 | Pathological Conditions, Signs and Symptoms |