Gas Exchange for Predicting Hospital Heart Failure Readmissions

Status unconfirmed

Conditions studied: Acute Decompensated Heart Failure

In brief

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.

Key facts

Study ID

NCT01960218

Run by

Shape Medical Systems, Inc.

People needed

120

Starts

2013-10-01

Expected to finish

2015-01-01

Last updated by the study team

2014-04-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Fairview Southdale — Edina, Minnesota, United States (enrolling)
• Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• Veterans Affairs-Washington DC — Washington D.C., District of Columbia, United States (enrolling)
• University of Minnesota — Minneapolis, Minnesota, United States (enrolling)
• Washington University of Medicine — St Louis, Missouri, United States (enrolling)
• Christie Clinic — Champaign, Illinois, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.