Gas Exchange for Predicting Hospital Heart Failure Readmissions

This study is currently recruiting participants.
Verified April 2014 by Shape Medical Systems, Inc.
Sponsor:
Information provided by (Responsible Party):
Shape Medical Systems, Inc.
ClinicalTrials.gov Identifier:
NCT01960218
First received: October 4, 2013
Last updated: April 3, 2014
Last verified: April 2014

October 4, 2013
April 3, 2014
October 2013
July 2014   (final data collection date for primary outcome measure)
  • 1. To evaluate if exercise gas exchange tests can predict 30 day hospital readmission for heart failure. [ Time Frame: 30 days ± 3 days post discharge ] [ Designated as safety issue: No ]
    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.
  • 2. To evaluate which gas exchange patterns were most highly associated with 30 day risk of readmission for recurrent acute decompensated heart failure. [ Time Frame: 30 days ± 3 days post discharge ] [ Designated as safety issue: No ]
    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.
  • 3. To determine the incidence of Adverse Events (AE) and Serious Adverse Events (SAE). [ Time Frame: 30 days ± 3 days post discharge follow-up and through 180 days ± 15 days post discharge ] [ Designated as safety issue: No ]
    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.
Same as current
Complete list of historical versions of study NCT01960218 on ClinicalTrials.gov Archive Site
  • 1. To evaluate if exercise gas exchange tests can predict 180 day hospital readmission for heart failure. [ Time Frame: 180 days ± 15 days post discharge ] [ Designated as safety issue: No ]
    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.
  • 2. To evaluate which gas exchange patterns were most highly associated with 180 day risk of readmission for recurrent acute decompensated heart failure. [ Time Frame: 180 days ± 15 days post discharge ] [ Designated as safety issue: No ]
    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.
Same as current
Not Provided
Not Provided
 
Gas Exchange for Predicting Hospital Heart Failure Readmissions
Gas Exchange for Predicting Hospital Heart Failure Readmissions Clinical Evaluation Study

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Subjects will be consecutively recruited from the population of subjects admitted to the hospital with acute decompensated heart failure.

Acute Decompensated Heart Failure
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
January 2015
July 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Not Provided
United States
 
NCT01960218
0512
No
Shape Medical Systems, Inc.
Shape Medical Systems, Inc.
Not Provided
Principal Investigator: Abraham G Kocheril, MD Christie Clinc
Shape Medical Systems, Inc.
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP