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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05405504
• Other study ID #: HJE-REDS-0001
• Status: Recruiting
• Start date: June 13, 2022
• Est. completion date: February 1, 2024

Study information

• Verified date: June 2022
• Source: Rigshospitalet, Denmark
• Contact: Frederik T Sondergaard, MS
• Phone: +4560633626
• Email: Frederik.tilma.soendergaard[@]regionh.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: February 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

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.

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Christian Hassager

Country where clinical trial is conducted

Denmark, 

References & Publications (9)

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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.

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. — View Citation

Outcome

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