NCT05405504

Brief Summary

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).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

May 23, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 6, 2022

Completed
7 days until next milestone

Study Start

First participant enrolled

June 13, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

June 14, 2022

Status Verified

June 1, 2022

Enrollment Period

1.6 years

First QC Date

May 23, 2022

Last Update Submit

June 13, 2022

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (2)

  • Correlation between ReDS ICU fluid parameters and Swan-Ganz measurements

    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

    mPAP (mmHg), dPAP (mmHg) and the percentage of fluid in the lungs (%)

    3 months

Secondary Outcomes (6)

  • Changes in ReDS ICU fluid parameters following changes in Positive End Expiratory Pressure

    During the first 72 hours after Swan-Ganz implantation

  • Changes in ReDS ICU fluid parameters following raised leg test

    During the first 72 hours after Swan-Ganz implantation

  • Changes in ReDS ICU fluid parameters following changes in body position

    During the first 72 hours after Swan-Ganz implantation

  • Changes in ReDS ICU fluid parameters following changes administration of diuretics and inotropic/inodilators

    During the first 72 hours after Swan-Ganz implantation

  • Correlation between ReDS v2.7 fluid parameters and body weight

    3 months

  • +1 more secondary outcomes

Study Arms (2)

ICU part

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

Device: Remote Dielectric Sensing (ReDS)

Out-patient part

Chronic heart failure patients with CardioMEMS.

Device: Remote Dielectric Sensing (ReDS)

Interventions

Remote Dielectric Sensing (ReDS)DEVICE

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.

ICU partOut-patient part

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

Related Publications (9)

  • Sattar Y, Suleiman A, Mir T, et al. TREND OF HEART FAILURE READMISSION PREVENTION IN REMOTE DIELECTRIC SENSING (REDS) MONITORING- A META-ANALYSIS. J Am Coll Cardiol. 2021 May, 77 (18_Supplement_1) 808.

    BACKGROUND

  • Abraham WT, Bensimhon D, Pinney SP, Feitell SC, Peacock WF, Amir O, Burkhoff D. Patient monitoring across the spectrum of heart failure disease management 10 years after the CHAMPION trial. ESC Heart Fail. 2021 Oct;8(5):3472-3482. doi: 10.1002/ehf2.13550. Epub 2021 Aug 13.

    PMID: 34390219BACKGROUND

  • Amir O, Azzam ZS, Gaspar T, Faranesh-Abboud S, Andria N, Burkhoff D, Abbo A, Abraham WT. Validation of remote dielectric sensing (ReDS) technology for quantification of lung fluid status: Comparison to high resolution chest computed tomography in patients with and without acute heart failure. Int J Cardiol. 2016 Oct 15;221:841-6. doi: 10.1016/j.ijcard.2016.06.323. Epub 2016 Jul 1.

    PMID: 27434357BACKGROUND

  • Uriel N, Sayer G, Imamura T, Rodgers D, Kim G, Raikhelkar J, Sarswat N, Kalantari S, Chung B, Nguyen A, Burkhoff D, Abbo A. Relationship Between Noninvasive Assessment of Lung Fluid Volume and Invasively Measured Cardiac Hemodynamics. J Am Heart Assoc. 2018 Nov 20;7(22):e009175. doi: 10.1161/JAHA.118.009175.

    PMID: 30571493BACKGROUND

  • Lala A, Barghash MH, Giustino G, Alvarez-Garcia J, Konje S, Parikh A, Ullman J, Keith B, Donehey J, Mitter SS, Trivieri MG, Contreras JP, Burkhoff D, Moss N, Mancini DM, Pinney SP. Early use of remote dielectric sensing after hospitalization to reduce heart failure readmissions. ESC Heart Fail. 2021 Apr;8(2):1047-1054. doi: 10.1002/ehf2.13026. Epub 2020 Dec 18.

    PMID: 33336881BACKGROUND

  • Amir O, Rappaport D, Zafrir B, Abraham WT. A novel approach to monitoring pulmonary congestion in heart failure: initial animal and clinical experiences using remote dielectric sensing technology. Congest Heart Fail. 2013 May-Jun;19(3):149-55. doi: 10.1111/chf.12021. Epub 2013 Jan 25.

    PMID: 23350643BACKGROUND

  • Bensimhon D, Alali SA, Curran L, Gelbart E, Garman DWV, Taylor R, Chase P, Peacock WF. The use of the reds noninvasive lung fluid monitoring system to assess readiness for discharge in patients hospitalized with acute heart failure: A pilot study. Heart Lung. 2021 Jan-Feb;50(1):59-64. doi: 10.1016/j.hrtlng.2020.07.003. Epub 2020 Jul 20.

    PMID: 32703623BACKGROUND

  • Imamura T, Hori M, Koi T, Fukui T, Oshima A, Fujioka H, Ueno Y, Onoda H, Tanaka S, Fukuda N, Ueno H, Kinugawa K. Relationship Between Body Posture and Lung Fluid Volume Assessed Using a Novel Noninvasive Remote Dielectric Sensing System. Circ Rep. 2021 Dec 3;4(1):25-28. doi: 10.1253/circrep.CR-21-0130. eCollection 2022 Jan 7.

    PMID: 35083385BACKGROUND

  • Amir O, Ben-Gal T, Weinstein JM, Schliamser J, Burkhoff D, Abbo A, Abraham WT. Evaluation of remote dielectric sensing (ReDS) technology-guided therapy for decreasing heart failure re-hospitalizations. Int J Cardiol. 2017 Aug 1;240:279-284. doi: 10.1016/j.ijcard.2017.02.120. Epub 2017 Mar 3.

    PMID: 28341372BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Christian Hassager, MD, DMSc, Professor

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Frederik T Sondergaard, MS

CONTACT

+4560633626Frederik.tilma.soendergaard@regionh.dk

Rasmus P Beeske, MD

CONTACT

+4530118033Rasmus.paulin.beske@regionh.dk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, DMSc, Professor in Cardiology

Study Record Dates

First Submitted

May 23, 2022

First Posted

June 6, 2022

Study Start

June 13, 2022

Primary Completion

February 1, 2024

Study Completion

February 1, 2024

Last Updated

June 14, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Access and final IPD criteria is pending final, complete publication of the study.
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)

Locations

DK(1)