Gas Exchange for Predicting Hospital Heart Failure Readmissions

NCT01960218 | Unknown

• 1 other identifier: 0512
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Acute Decompensated Heart Failure

Keywords

acute decompensated heart failure; gas exchange; cardiopulmonary; dyspnea; cardiopulmonary analyzer; heart disease; cardiovascular disease; cardiopulmonary exercise

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Secondary Outcomes (2)

• 1. To evaluate if exercise gas exchange tests can predict 180 day hospital readmission for heart failure.

  180 days ± 15 days post discharge

• 2. To evaluate which gas exchange patterns were most highly associated with 180 day risk of readmission for recurrent acute decompensated heart failure.

  180 days ± 15 days post discharge

Study Arms (1)

acute decompensated heart failure

Adult subjects anticipating discharge from a hospitalization where the primary discharge diagnosis is acute decompensated heart failure and who are not excluded due to existing conditions.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects will be consecutively recruited from the population of subjects admitted to the hospital with acute decompensated heart failure.

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

Sponsors & Collaborators

• Shape Medical Systems, Inc.: lead

Study Sites (7)

Veterans Affairs-Washington DC

Washington D.C., District of Columbia, 20422, United States

RECRUITING

Christie Clinic

Champaign, Illinois, 61820, United States

NOT YET RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Fairview Southdale

Edina, Minnesota, 55435, United States

RECRUITING

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

Washington University of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

Related 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.

  PMID: 18672162 BACKGROUND

• 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. doi: 10.1067/mhj.2002.119608.

  PMID: 11773911 BACKGROUND

• 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.

  PMID: 21164330 BACKGROUND

• 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. doi: 10.1161/CIRCULATIONAHA.104.492207. Epub 2005 Aug 1.

  PMID: 16061743 BACKGROUND

MeSH Terms

Conditions

Dyspnea; Heart Diseases; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Abraham G Kocheril, MD

  Christie Clinc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2013
• First Posted: October 10, 2013
• Study Start: October 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: January 1, 2015
• Last Updated: April 4, 2014

Record last verified: 2014-04

Locations

US (7)