Gas Exchange for Predicting Hospital Heart Failure Readmissions

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014