Bioimpedance Spectroscopy Compared to CardioMEMS™

Bioimpedance Spectroscopy Compared to CardioMEMS™ Determined Pulmonary Artery Pressure Measurements

Comparison of changes in diastolic pulmonary artery pressure as measured by CardioMEMS™ to impedance parameters as measured by ImpediMed's BIS technology.

Study Overview

• Status: Completed
• Conditions: NYHA Class III Heart Failure

Detailed Description

This is a prospective, single-arm, observational, non-randomized clinical study that will enroll patients with heart failure who have had a CardioMEMS™ device implanted to monitor their diastolic pulmonary artery pressure. The study will recruit and enroll ten participants from the Scripps Clinic. Participants will be monitored 3 times a week for a period of 4 weeks. At each monitoring visit, the patient's diastolic pulmonary artery pressure will be measured by CardioMEMS™ and the ImpediMed's BIS technology. Participant's vital signs and weight will also be taken at each monitoring visit.

• Study Type: Observational
• Enrollment (Actual): 16

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • Scripps Clinic, John R. Anderson V Medical Pavilion

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

Heart failure patients who have a CardioMEMS device

Description

Inclusion Criteria:

Patient:

1. has an CardioMEMs device implanted
2. has been diagnosed with various stages of heart failure as described by New York Heart Association (NYHA)
3. is able to give informed consent

Exclusion Criteria:

Patient:

1. has pacemaker/ICD
2. is pregnant or breastfeeding
3. is an amputee
4. has been diagnosed with multiple medical conditions that would make participation burdensome
5. not able to co-operate with impedance measurements

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in bioimpedance measurement at 4 weeks	Change in impedance values will be tracked from baseline for 4 weeks and compared to CardioMEMS measures	Baseline and 4 weeks

Collaborators and Investigators

• Sponsor: ImpediMed Limited

Publications and helpful links

General Publications

• Accardi AJ, Matsubara BS, Gaw RL, Daleiden-Burns A, Heywood JT. Clinical Utility of Fluid Volume Assessment in Heart Failure Patients Using Bioimpedance Spectroscopy. Front Cardiovasc Med. 2021 Apr 7;8:636718. doi: 10.3389/fcvm.2021.636718. eCollection 2021.

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2017
• Primary Completion (Actual): March 19, 2018
• Study Completion (Actual): October 9, 2018

Study Registration Dates

• First Submitted: July 27, 2016
• First Submitted That Met QC Criteria: August 2, 2016
• First Posted (Estimate): August 5, 2016

Study Record Updates

• Last Update Posted (Actual): July 8, 2019
• Last Update Submitted That Met QC Criteria: July 5, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Bioimpedance spectroscopy
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: IPD-SCRIPPS-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is a pilot study, no individual participant data will be made available.