Clinical trial NCT01960218: Gas Exchange for Predicting Hospital Heart Failure Readmissions
Official title: Gas Exchange for Predicting Hospital Heart Failure Readmissions Clinical Evaluation Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Decompensated Heart Failure
Keywords: acute decompensated heart failure
gas exchange
cardiopulmonary
dyspnea
cardiopulmonary analyzer
heart disease
cardiovascular disease
cardiopulmonary exercise
Lead sponsor: Shape Medical Systems, Inc.
Sponsor class: INDUSTRY
First posted: 2013-10-10
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects will be consecutively recruited from the population of subjects admitted to the hospital with acute decompensated heart failure.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Subject is 18 Years and older
* 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:

* The subject is pregnant (verified in a manner consistent with institution's standard of care)
* 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

Primary outcomes:
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
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
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
Secondary outcomes:
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
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
Other outcomes:
Locations:
city: Washington
country: United States
facility: Veterans Affairs-Washington DC
state: District of Columbia
city: Champaign
country: United States
facility: Christie Clinic
state: Illinois
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Edina
country: United States
facility: Fairview Southdale
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: St. Louis
country: United States
facility: Washington University of Medicine
state: Missouri
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: Christie Clinc
name: Abraham G Kocheril, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.