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.

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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.

View Eligibility Criteria

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

Study is for people with:

Heart Failure

Estimated Enrollment:

120

Study ID:

NCT01960218

Recruitment Status:

Unknown status

Sponsor:

Shape Medical Systems, Inc.

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There are 7 Locations for this study

See Locations Near You

Veterans Affairs-Washington DC
Washington District of Columbia, 20422, United States More Info
Jacqueline Gannuscio, DNP, ACNP
Contact
202-745-8000
Jacqueline Gannuscio, DNP, ACNP
Principal Investigator
Christie Clinic
Champaign Illinois, 61820, United States More Info
Diane Genthner
Contact
217-337-2221
Abraham G Kocheril, MD
Principal Investigator
Massachusetts General Hospital
Boston Massachusetts, 02114, United States More Info
Aaron Eisman
Contact
617-643-1697
Ashley Dress
Contact
617.643.1697
Gregory Lewis, MD
Principal Investigator
Fairview Southdale
Edina Minnesota, 55435, United States More Info
Jennifer Nelson, RN
Contact
612-625-9455
Eric Ernst, MD
Principal Investigator
University of Minnesota
Minneapolis Minnesota, 55455, United States More Info
Jennifer Nelson, RN
Contact
612-625-0455
Peter Eckman, MD
Principal Investigator
Washington University of Medicine
St. Louis Missouri, 63110, United States More Info
Jessica Biondo, RN
Contact
314-286-1767
Gregory A Ewald, MD, FACC
Principal Investigator
Cleveland Clinic
Cleveland Ohio, 44195, United States More Info
Ellen Slifcak, BA, RN
Contact
216-445-1776
Nancy Albert, PhD., R.N.
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

120

Study ID:

NCT01960218

Recruitment Status:

Unknown status

Sponsor:


Shape Medical Systems, Inc.

How clear is this clinincal trial information?

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