NCT02857231

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 5, 2016

Completed
1 year until next milestone

Study Start

First participant enrolled

August 7, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 19, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 9, 2018

Completed
Last Updated

July 8, 2019

Status Verified

July 1, 2019

Enrollment Period

7 months

First QC Date

July 27, 2016

Last Update Submit

July 5, 2019

Conditions

NYHA Class III Heart Failure

Keywords

Bioimpedance spectroscopy

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Heart failure patients who have a CardioMEMS device

You may qualify if:

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

You may not qualify if:

  • Patient:
  • has pacemaker/ICD
  • is pregnant or breastfeeding
  • is an amputee
  • has been diagnosed with multiple medical conditions that would make participation burdensome
  • not able to co-operate with impedance measurements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Scripps Clinic, John R. Anderson V Medical Pavilion

La Jolla, California, 92037, United States

Location

Related Publications (1)

  • 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.

    PMID: 33898536DERIVED

Biospecimen

Retention: NONE RETAINED

Two blood samples for each participant with be taken, baseline and last study visit.

Study Officials

  • James T Heywood, MD

    Scripps Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2016

First Posted

August 5, 2016

Study Start

August 7, 2017

Primary Completion

March 19, 2018

Study Completion

October 9, 2018

Last Updated

July 8, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

This is a pilot study, no individual participant data will be made available.

Locations

US(1)