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

Christian Hassager

Status

Enrolling

Conditions

Heart Failure

Treatments

Device: Remote Dielectric Sensing (ReDS)

Study type

Observational

Funder types

Other

Identifiers

NCT05405504

HJE-REDS-0001

Details and patient eligibility

About

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).

Full 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.

Enrollment

25 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.