Gas Exchange for Predicting Hospital Heart Failure Readmissions

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.

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