Gas Exchange for Predicting Hospital Heart Failure Readmissions

Acute Decompensated Heart Failure Clinical Trial

Official title:

Gas Exchange for Predicting Hospital Heart Failure Readmissions Clinical Evaluation Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01960218
• Other study ID #: 0512
• Status: Recruiting
• Phase: N/A
• First received: October 4, 2013
• Last updated: April 3, 2014
• Start date: October 2013
• Est. completion date: January 2015

Study information

• Verified date: April 2014
• Source: Shape Medical Systems, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: January 2015
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Decompensated Heart Failure
• Heart Failure

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Christie Clinic	Champaign	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	Fairview Southdale	Edina	Minnesota
United States	University of Minnesota	Minneapolis	Minnesota
United States	Washington University of Medicine	St. Louis	Missouri
United States	Veterans Affairs-Washington DC	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Shape Medical Systems, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (4)

Fang J, Mensah GA, Croft JB, Keenan NL. Heart failure-related hospitalization in the U.S., 1979 to 2004. J Am Coll Cardiol. 2008 Aug 5;52(6):428-34. doi: 10.1016/j.jacc.2008.03.061. — View Citation

Jacobs B. Reducing heart failure hospital readmissions from skilled nursing facilities. Prof Case Manag. 2011 Jan-Feb;16(1):18-24; quiz 25-6. doi: 10.1097/NCM.0b013e3181f3f684. — View Citation

Pulignano G, Del Sindaco D, Tavazzi L, Lucci D, Gorini M, Leggio F, Porcu M, Scherillo M, Opasich C, Di Lenarda A, Senni M, Maggioni AP; IN-CHF Investigators. Clinical features and outcomes of elderly outpatients with heart failure followed up in hospital cardiology units: data from a large nationwide cardiology database (IN-CHF Registry). Am Heart J. 2002 Jan;143(1):45-55. — View Citation

Yu CM, Wang L, Chau E, Chan RH, Kong SL, Tang MO, Christensen J, Stadler RW, Lau CP. Intrathoracic impedance monitoring in patients with heart failure: correlation with fluid status and feasibility of early warning preceding hospitalization. Circulation. 2005 Aug 9;112(6):841-8. Epub 2005 Aug 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No