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Clinical Trials/NCT02134379
NCT02134379
Completed
Not Applicable

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

Charles Porter, MD1 site in 1 country11 target enrollmentApril 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Failure; With Decompensation
Sponsor
Charles Porter, MD
Enrollment
11
Locations
1
Primary Endpoint
Change from sitting to supine to standing in thoracic impedance
Status
Completed
Last Updated
10 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
April 2014
End Date
January 2016
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Charles Porter, MD
Responsible Party
Sponsor Investigator
Principal Investigator

Charles Porter, MD

Clinical Associate Professor

University of Kansas Medical Center

Eligibility 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

Outcomes

Primary Outcomes

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

  • Rate of change in thoracic impedance(Baseline, 30 days)

Study Sites (1)

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