Gas Exchange for Predicting Hospital Heart Failure Readmissions

Study Overview
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Brief Summary
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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
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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.

Official Title
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Gas Exchange for Predicting Hospital Heart Failure Readmissions Clinical Evaluation Study

Conditions
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Acute Decompensated Heart Failure

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is 18 Years and older Subject is hospitalized for acute decompensated heart failure (ADHF) Systolic OR 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| acute decompensated heart failure<br>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?
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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. | 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. | 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). | 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. | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute decompensated heart failure, gas exchange, cardiopulmonary, dyspnea, cardiopulmonary analyzer, heart disease, cardiovascular disease, cardiopulmonary exercise