Heart Failure Clinical Trial
Gas Exchange for Predicting Hospital Heart Failure Readmissions
Summary
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.
Full 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 Criteria
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
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There are 7 Locations for this study
Washington District of Columbia, 20422, United States More Info
Principal Investigator
Champaign Illinois, 61820, United States More Info
Principal Investigator
Boston Massachusetts, 02114, United States More Info
Principal Investigator
Edina Minnesota, 55435, United States More Info
Principal Investigator
Minneapolis Minnesota, 55455, United States More Info
Principal Investigator
St. Louis Missouri, 63110, United States More Info
Principal Investigator
Cleveland Ohio, 44195, United States More Info
Principal Investigator
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