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
  Purpose

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.


Condition
Acute Decompensated Heart Failure

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Gas Exchange for Predicting Hospital Heart Failure Readmissions Clinical Evaluation Study

Resource links provided by NLM:


Further study details as provided by Shape Medical Systems, Inc.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 120
Study Start Date: October 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01960218

Locations
United States, District of Columbia
Veterans Affairs-Washington DC Recruiting
Washington, District of Columbia, United States, 20422
Contact: Jacqueline Gannuscio, DNP, ACNP    202-745-8000 ext 7297      
Principal Investigator: Jacqueline Gannuscio, DNP, ACNP         
United States, Illinois
Christie Clinic Not yet recruiting
Champaign, Illinois, United States, 61820
Contact: Diane Genthner    217-337-2221      
Principal Investigator: Abraham G Kocheril, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Aaron Eisman    617-643-1697      
Contact: Ashley Dress    617.643.1697      
Principal Investigator: Gregory Lewis, MD         
United States, Minnesota
Fairview Southdale Recruiting
Edina, Minnesota, United States, 55435
Contact: Jennifer Nelson, RN    612-625-9455      
Principal Investigator: Eric Ernst, MD         
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Jennifer Nelson, RN    612-625-0455      
Principal Investigator: Peter Eckman, MD         
United States, Missouri
Washington University of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Jessica Biondo, RN    314-286-1767      
Principal Investigator: Gregory A Ewald, MD, FACC         
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Ellen Slifcak, BA, RN    216-445-1776      
Principal Investigator: Nancy Albert, PhD., R.N.         
Sponsors and Collaborators
Shape Medical Systems, Inc.
Investigators
Principal Investigator: Abraham G Kocheril, MD Christie Clinc
  More Information

Publications:
Responsible Party: Shape Medical Systems, Inc.
ClinicalTrials.gov Identifier: NCT01960218     History of Changes
Other Study ID Numbers: 0512
Study First Received: October 4, 2013
Last Updated: April 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Shape Medical Systems, Inc.:
acute decompensated heart failure
gas exchange
cardiopulmonary
dyspnea
cardiopulmonary analyzer
heart disease
cardiovascular disease
cardiopulmonary exercise

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014