Evaluation of ReDS Pro System V2.7 and ReDS ICU in Patients With Heart Failure

June 13, 2022 updated by: Christian Hassager
The study is an investigator-initiated, prospective cohort trial. The trial aims to evaluate ReDS Pro System V2.7 and ReDS ICU in patients with heart failure (HF).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study is an investigator-initiated, prospective cohort trial. The trial aims to evaluate ReDS Pro System V2.7 and ReDS ICU in patients with heart failure (HF). The overall purposes are:

  • to evaluate the ReDS efficacy measurements of lung fluid compared to pulmonary artery pressure guided therapy with CardioMEMS in out-patients with HF.
  • to describe the feasibility of ReDS ICU in patients admitted to an ICU with HF

For the out-patient part, the patients will be recruited from the outpatient clinic at Rigshospitalet. The patient must be at least 18 years, have a history of chronic HF, and already monitored using CardioMEMS and must not fulfill any of the exclusion criteria.

For the ICU part, the patients will be recruited at the ICU department at the Heart Center at Rigshospitalet. The patient must be at least 18 years, intubated, and unconscious or sedated (Glasgow Coma Score <8), and already monitored using Swan-Ganz and arterial catherization and must not fulfill any of the exclusion criteria.

Study Type

Observational

Enrollment (Anticipated)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

ICU part:

Acute heart failure patients with Swan-Ganz catheter and an arterial catheter.

Outpatient part:

Chronic heart failure patients with CardioMEMS.

Description

Inclusion Criteria:

ICU part:

  • at least 18 years of age
  • hospitalized in ICU setting at Rigshospitalet
  • intubated
  • unconscious or sedated (Glasgow Coma Score <8)
  • monitored using Swan-Ganz and arterial catherization.

Out-patient part:

  • at least 18 years of age
  • history of Chronic heart failure > 3 months
  • CardioMEMS

Exclusion Criteria:

ICU part:

  • pacemaker or ICD on the right side
  • congenital heart malformations or intra-thoracic mass that would affect the right lung anatomy (e.g. dextrocardia, lung carcinoma)
  • wounds, burns, healing tissue, skin infection or recent skin graft or flap where the sensors should be attached to the skin
  • habitus is out of range due to one or more of the following
  • height less than 155 cm or higher than 195 cm
  • estimated BMI of less than 22 or more than 36
  • standard active therapy has been stopped as the patient is inevitably dying.

Out-patient part:

  • pacemaker or ICD on the right side
  • congenital heart malformations or intra-thoracic mass that would affect the right lung anatomy (e.g. dextrocardia, lung carcinoma)
  • wounds, burns, healing tissue, skin infection or recent skin graft or flap where the sensors should be attached to the skin
  • habitus is out of range due to one or more of the following Height less than 155 cm or higher than 195 cm BMI of less than 22 or more than 38 For BMI 36 to 38, chest size ruler should be 39 or less
  • cancer or other severe non-cardiac disease with estimated life expectancy less than 1 year
  • planned hospitalization for ICD, pacemaker, lung or heart surgery including heart transplantation during the study period.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ICU part
Acute heart failure patients with Swan-Ganz catheter and an arterial catheter.
Device: Remote Dielectric Sensing (ReDS)
Non-invasive device designed for the measurement of lung fluid using extremely low power electromagnetic waves. The ReDS Pro System V2.7 system has CE approval (3900874CE01) and FDA clearance.
Out-patient part
Chronic heart failure patients with CardioMEMS.
Device: Remote Dielectric Sensing (ReDS)
Non-invasive device designed for the measurement of lung fluid using extremely low power electromagnetic waves. The ReDS Pro System V2.7 system has CE approval (3900874CE01) and FDA clearance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between ReDS ICU fluid parameters and Swan-Ganz measurements
Time Frame: Daily Swan-Ganz catheter and ReDS ICU measurements the first 72 hours after Swan-Ganz implantation
Measurements on Swan-Ganz catheter (CVP, PAP, PCWP - all in mmHg) and the percentage of fluid in the lungs (%)
Daily Swan-Ganz catheter and ReDS ICU measurements the first 72 hours after Swan-Ganz implantation
Correlation between ReDS v2.7 fluid parameters and CardioMEMS measurements
Time Frame: 3 months
mPAP (mmHg), dPAP (mmHg) and the percentage of fluid in the lungs (%)
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in ReDS ICU fluid parameters following changes in Positive End Expiratory Pressure
Time Frame: During the first 72 hours after Swan-Ganz implantation
The percentage of fluid in the lungs (%) and PEEP
During the first 72 hours after Swan-Ganz implantation
Changes in ReDS ICU fluid parameters following raised leg test
Time Frame: During the first 72 hours after Swan-Ganz implantation
The percentage of fluid in the lungs (%)
During the first 72 hours after Swan-Ganz implantation
Changes in ReDS ICU fluid parameters following changes in body position
Time Frame: During the first 72 hours after Swan-Ganz implantation
The percentage of fluid in the lungs (%)
During the first 72 hours after Swan-Ganz implantation
Changes in ReDS ICU fluid parameters following changes administration of diuretics and inotropic/inodilators
Time Frame: During the first 72 hours after Swan-Ganz implantation
The percentage of fluid in the lungs (%)
During the first 72 hours after Swan-Ganz implantation
Correlation between ReDS v2.7 fluid parameters and body weight
Time Frame: 3 months
The percentage of fluid in the lungs (%)
3 months
Correlation between ReDS v2.7 fluid parameters and dyspnea symptom evaluated by NYHA class.
Time Frame: 3 months
The percentage of fluid in the lungs (%)
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Christian Hassager

Investigators

  • Principal Investigator: Christian Hassager, MD, DMSc, Professor, Rigshospitalet, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 13, 2022

Primary Completion (Anticipated)

February 1, 2024

Study Completion (Anticipated)

February 1, 2024

Study Registration Dates

First Submitted

May 23, 2022

First Submitted That Met QC Criteria

May 31, 2022

First Posted (Actual)

June 6, 2022

Study Record Updates

Last Update Posted (Actual)

June 14, 2022

Last Update Submitted That Met QC Criteria

June 13, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HJE-REDS-0001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Data is planned to be available upon reasonable request via the Principal Investigator pending final, complete publication of the study.

IPD Sharing Time Frame

Access and final IPD criteria is pending final, complete publication of the study.

IPD Sharing Access Criteria

Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA)

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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