Dynamic Thoracic Impedance as a Marker for Heart Failure Decompensation

NCT02134379 | Completed

• 1 other identifier: STUDY00000596
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; With Decompensation

Keywords

Thoracic Impedance; Diagnostic Marker; Bed Rest Test; Transthoracic Impedance; Heart Failure; HF

Outcome Measures

Primary Outcomes (1)

• Change from sitting to supine to standing in thoracic impedance

  thoracic impedance will be measured at each position at baseline visit then again at the follow-up visits through 30 days

  Baseline, 30 Days

Secondary Outcomes (1)

• Rate of change in thoracic impedance

  Baseline, 30 days

Study Arms (1)

Heart Failure

Subjects have implanted Medtronic device and a primary diagnosis of left ventricular systolic dysfunction

Device: Medtronic ICDs, CRT-Ds, and CRT-Ps

Interventions

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.

Also known as: 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)

Heart Failure

Eligibility Criteria

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

Study Population

Subjects will be identified from the KU Hospital Cardiology clinic.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charles Porter, MD: lead
• Medtronic: collaborator

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Charles Porter, MD, FACC, FACP

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: May 7, 2014
• First Posted: May 9, 2014
• Study Start: April 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: April 14, 2016

Record last verified: 2016-04

Locations

US (1)