Gas Exchange for Predicting Hospital Heart Failure Readmissions

April 3, 2014 updated by: Shape Medical Systems, Inc.

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.

Study Overview

Status

Unknown

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.

Study Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
Time Frame: 30 days ± 3 days post discharge
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).
Time Frame: 30 days ± 3 days post discharge follow-up and through 180 days ± 15 days post discharge
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shape Medical Systems, Inc.

Investigators

  • Principal Investigator: Abraham G Kocheril, MD, Christie Clinc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Anticipated)

July 1, 2014

Study Completion (Anticipated)

January 1, 2015

Study Registration Dates

First Submitted

October 4, 2013

First Submitted That Met QC Criteria

October 8, 2013

First Posted (Estimate)

October 10, 2013

Study Record Updates

Last Update Posted (Estimate)

April 4, 2014

Last Update Submitted That Met QC Criteria

April 3, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0512

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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