Gas Exchange for Predicting Hospital Heart Failure Readmissions
3. april 2014 oppdatert av: Shape Medical Systems, Inc.
Gas Exchange for Predicting Hospital Heart Failure Readmissions Clinical Evaluation Study
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.
Studieoversikt
Status
Ukjent
Forhold
Detaljert beskrivelse
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.
Studietype
Observasjonsmessig
Registrering (Forventet)
120
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
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District of Columbia
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Washington, District of Columbia, Forente stater, 20422
- Rekruttering
- Veterans Affairs-Washington DC
-
Ta kontakt med:
- Jacqueline Gannuscio, DNP, ACNP
- Telefonnummer: 7297 202-745-8000
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Hovedetterforsker:
- Jacqueline Gannuscio, DNP, ACNP
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Illinois
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Champaign, Illinois, Forente stater, 61820
- Har ikke rekruttert ennå
- Christie Clinic
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Ta kontakt med:
- Diane Genthner
- Telefonnummer: 217-337-2221
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Hovedetterforsker:
- Abraham G Kocheril, MD
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Massachusetts
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Boston, Massachusetts, Forente stater, 02114
- Rekruttering
- Massachusetts General Hospital
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Ta kontakt med:
- Aaron Eisman
- Telefonnummer: 617-643-1697
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Ta kontakt med:
- Ashley Dress
- Telefonnummer: 617.643.1697
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Minnesota
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Edina, Minnesota, Forente stater, 55435
- Rekruttering
- Fairview Southdale
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Ta kontakt med:
- Jennifer Nelson, RN
- Telefonnummer: 612-625-9455
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Hovedetterforsker:
- Eric Ernst, MD
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Minneapolis, Minnesota, Forente stater, 55455
- Rekruttering
- University of Minnesota
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Hovedetterforsker:
- Peter Eckman, MD
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Ta kontakt med:
- Jennifer Nelson, RN
- Telefonnummer: 612-625-0455
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Missouri
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St. Louis, Missouri, Forente stater, 63110
- Rekruttering
- Washington University of Medicine
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Ta kontakt med:
- Jessica Biondo, RN
- Telefonnummer: 314-286-1767
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Hovedetterforsker:
- Gregory A Ewald, MD, FACC
-
-
Ohio
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Cleveland, Ohio, Forente stater, 44195
- Rekruttering
- Cleveland Clinic
-
Ta kontakt med:
- Ellen Slifcak, BA, RN
- Telefonnummer: 216-445-1776
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Hovedetterforsker:
- Nancy Albert, PhD., R.N.
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Sannsynlighetsprøve
Studiepopulasjon
Subjects will be consecutively recruited from the population of subjects admitted to the hospital with acute decompensated heart failure.
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
1. To evaluate if exercise gas exchange tests can predict 30 day hospital readmission for heart failure.
Tidsramme: 30 days ± 3 days post discharge
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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.
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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.
Tidsramme: 30 days ± 3 days post discharge
|
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).
Tidsramme: 30 days ± 3 days post discharge follow-up and through 180 days ± 15 days post discharge
|
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.
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30 days ± 3 days post discharge follow-up and through 180 days ± 15 days post discharge
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
1. To evaluate if exercise gas exchange tests can predict 180 day hospital readmission for heart failure.
Tidsramme: 180 days ± 15 days post discharge
|
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
|
|
2. To evaluate which gas exchange patterns were most highly associated with 180 day risk of readmission for recurrent acute decompensated heart failure.
Tidsramme: 180 days ± 15 days post discharge
|
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Abraham G Kocheril, MD, Christie Clinc
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
- 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.
- 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.
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. oktober 2013
Primær fullføring (Forventet)
1. juli 2014
Studiet fullført (Forventet)
1. januar 2015
Datoer for studieregistrering
Først innsendt
4. oktober 2013
Først innsendt som oppfylte QC-kriteriene
8. oktober 2013
Først lagt ut (Anslag)
10. oktober 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
4. april 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
3. april 2014
Sist bekreftet
1. april 2014
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 0512
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