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Dynamic Thoracic Impedance as a Marker for Heart Failure Decompensation

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ClinicalTrials.gov Identifier: NCT02134379
Recruitment Status : Completed
First Posted : May 9, 2014
Last Update Posted : April 14, 2016
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Charles Porter, MD, University of Kansas Medical Center

Brief Summary:
This pilot study proposes to perform measurements of approved thoracic impedance technology that will help answer questions in patients with decompensated heart failure.

Condition or disease Intervention/treatment
Heart Failure; With Decompensation Device: Medtronic ICDs, CRT-Ds, and CRT-Ps

Detailed Description:
Improved metrics derived from the transthoracic impedance (Z) available from implanted Medtronic devices may provide more sensitive indicators of the state of compensation for heart failure patients. Quantification of specific data may provide new information that can improve quality of life for patients and offer vital information to clinicians regarding the adequacy of inpatient and outpatient assessment and management of acute decompensated heart failure.

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Study Type : Observational
Actual Enrollment : 11 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Dynamic Thoracic Impedance as a Marker for Heart Failure Decompensation: A Pilot Trial of the "Dynamic Thoracic Impedance Bed Rest Test"
Study Start Date : April 2014
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Group/Cohort Intervention/treatment
Heart Failure
Subjects have implanted Medtronic device and a primary diagnosis of left ventricular systolic dysfunction
Device: Medtronic ICDs, CRT-Ds, and CRT-Ps
Any Medtronic implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) device. Device must have capacity to measure thoracic impedance as described in protocol. This includes the majority of FDA-approved Medtronic devices currently in use.
Other Names:
  • ICDs:
  • Evera(TM) XT DR (Models DDBB1D4, DDBB1D1)
  • Evera(TM) XT VR (Models DVBB1D4, DVBB1D1)
  • Protecta(R) XT DR (Models D314DRG, D314DRM)
  • Protecta(R) XT VR (Models D314VRG, D314VRM)
  • Secura(R) DR (Models D224DRG, D204DRM)
  • Secura(R) VR (Models D224VRC, D204VRM)
  • Virtuoso(R) II DR (Model D274DRG)
  • Virtuoso(R) II VR (Model D274VRC)
  • Virtuoso(R) DR (Model D154AWG)
  • Virtuoso(R) VR (Model D154VWC)
  • CRT-Ds/CRT-Ps:
  • Viva(TM) XT CRT-D (Models DTBA1D1, DTBA1D4)
  • Viva(TM) S CRT-D (Models DTBB1D1, DTBB1D4)
  • InSync Sentry(R) CRT-D (Models 7297, 7299)
  • Protecta(R) XT CRT-D (Models D314TRM, D314TRG)
  • Concerto(R) II CRT-D (Model D274TRK)
  • Consulta(R) CRT-D (Models D204TRM, D224TRK)
  • Concerto(R) CRT-D (Models C154DWK, C164AWK)
  • Consulta(R) CRT-P (Model C4TR01)




Primary Outcome Measures :
  1. Change from sitting to supine to standing in thoracic impedance [ Time Frame: Baseline, 30 Days ]
    thoracic impedance will be measured at each position at baseline visit then again at the follow-up visits through 30 days


Secondary Outcome Measures :
  1. Rate of change in thoracic impedance [ Time Frame: Baseline, 30 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects will be identified from the KU Hospital Cardiology clinic.
Criteria

Inclusion Criteria:

  • Patients with systolic dysfunction
  • Able to provide informed consent
  • Have a Medtronic manufactured device with Thoracic Impendence Monitoring capabilities

Exclusion Criteria:

  • Patients with severe congestive heart failure who are intubated
  • Patients who are oxygen dependent on continuous positive or bilevel positive ventilation
  • Inability to tolerate postural variations due to congestive heart failure or other medical or surgical condition.Unable to complete proposed testing
  • Subjects who cannot giveWill not give written, informed consent on their own behalf

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02134379


Locations
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United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
Charles Porter, MD
Medtronic
Investigators
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Principal Investigator: Charles Porter, MD, FACC, FACP University of Kansas Medical Center
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Responsible Party: Charles Porter, MD, Clinical Associate Professor, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT02134379    
Other Study ID Numbers: STUDY00000596
First Posted: May 9, 2014    Key Record Dates
Last Update Posted: April 14, 2016
Last Verified: April 2016
Keywords provided by Charles Porter, MD, University of Kansas Medical Center:
Thoracic Impedance
Diagnostic Marker
Bed Rest Test
Transthoracic Impedance
Heart Failure
HF
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Clotrimazole
Miconazole
Anti-Infective Agents, Local
Anti-Infective Agents
Antifungal Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP3A Inhibitors