Dynamic Thoracic Impedance as a Marker for Heart Failure Decompensation

Completed

• Conditions: Heart Failure; With Decompensation
• Interventions: Device: Medtronic ICDs, CRT-Ds, and CRT-Ps

• Registration Number: NCT02134379
• Lead Sponsor: Charles Porter, MD

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.

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-05-07
• Study First Submitted QC: 2014-05-07
• Study First Posted: 2014-05-09
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-13
• Last Update Posted: 2016-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Heart Failure	Medtronic ICDs, CRT-Ds, and CRT-Ps	Subjects have implanted Medtronic device and a primary diagnosis of left ventricular systolic dysfunction

Primary Outcome Measures

Name	Time	Method
Change from sitting to supine to standing in thoracic impedance	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

Name	Time	Method
Rate of change in thoracic impedance	Baseline, 30 days

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States