Dynamic Thoracic Impedance as a Marker for Heart Failure Decompensation

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

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

Study Overview

• Status: Completed
• Conditions: Heart Failure; With Decompensation
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 11

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects will be identified from the KU Hospital Cardiology clinic.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Rate of change in thoracic impedance	Baseline, 30 days

Collaborators and Investigators

• Sponsor: Charles Porter, MD
• Collaborators: Medtronic
• Investigators: Principal Investigator: Charles Porter, MD, FACC, FACP, University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: May 7, 2014
• First Submitted That Met QC Criteria: May 7, 2014
• First Posted (Estimate): May 9, 2014

Study Record Updates

• Last Update Posted (Estimate): April 14, 2016
• Last Update Submitted That Met QC Criteria: April 13, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Heart Failure; HF; Thoracic Impedance; Diagnostic Marker; Bed Rest Test; Transthoracic Impedance
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Cytochrome P-450 CYP2C9 Inhibitors; Clotrimazole; Miconazole
• Other Study ID Numbers: STUDY00000596

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No