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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02134379

Enrollment

Registered

2014-05-09

Start date

2014-04-30

Completion date

2016-01-31

Last updated

2016-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure; With Decompensation

Keywords

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

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.

Interventions

DEVICEMedtronic 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.

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026