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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

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

Conditions
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Heart Failure

Intervention / Treatment
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* Device: Remote Dielectric Sensing (ReDS)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ICU part<br>Acute heart failure patients with Swan-Ganz catheter and an arterial catheter. | Device: Remote Dielectric Sensing (ReDS)<br>* 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.<br>|
| Out-patient part<br>Chronic heart failure patients with CardioMEMS. | Device: Remote Dielectric Sensing (ReDS)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Correlation between ReDS v2.7 fluid parameters and body weight | The percentage of fluid in the lungs (%) | 3 months | 
| Correlation between ReDS v2.7 fluid parameters and dyspnea symptom evaluated by NYHA class. | The percentage of fluid in the lungs (%) | 3 months |