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Completed

NCT Number: NCT02134379

Dynamic Thoracic Impedance as a Marker for Heart Failure Decompensation

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

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Key information

Conditions

Heart Failure; With Decompensation Cardiovascular Diseases Heart Diseases Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medtronic ICDs, CRT-Ds, and CRT-Ps

Device

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 outcomes

  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 outcomes

  1. Rate of change in thoracic impedance

    Time frame: Baseline, 30 days

Sponsors and collaborators

Lead sponsor

Charles Porter, MD

Other

Collaborators

  • Medtronic

Registry information

Official study title

Dynamic Thoracic Impedance as a Marker for Heart Failure Decompensation: A Pilot Trial of the "Dynamic Thoracic Impedance Bed Rest Test"

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 9, 2014
Registry last updated
Apr 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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