Dynamic Thoracic Impedance as a Marker for Heart Failure Decompensation

Heart Failure; With Decompensation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02134379
• Other study ID #: STUDY00000596
• Status: Completed
• Phase: N/A
• First received: May 7, 2014
• Last updated: April 13, 2016
• Start date: April 2014
• Est. completion date: January 2016

Study information

• Verified date: April 2016
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure; With Decompensation

Intervention

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.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Charles Porter, MD	Medtronic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Rate of change in thoracic impedance		Baseline, 30 days	No