The CPM wearable device and measures of congestion study. V1.0
Research type
Research Study
Full title
Correlation of the non-invasive Cardiopulmonary Management (CPM) wearable device with measures of congestion in heart failure- CONGEST-HF
IRAS ID
276197
Contact name
PS Jhund
Contact email
Sponsor organisation
NHS Greater Glasgow & Clyde Research & Innovations
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
This study is being conducted to assess how effective the Cardiopulmonary Management (CPM) wearable device is at measuring congestion (excess fluid) in patients who are actively experiencing congestion.
The build up of congestion is a prominent feature in heart failure and a major contributor to heart failure hospitalisations. Recognising changes in excess fluid status either before a patient becomes unwell or during decongestion treatment is highly desirable so that timely treatment can be started or so that treatment can be adjusted based on an individual's response to therapy. The ability to assess patients by applying a patch-like, non-invasive wearable device would provide a useful, practical tool for assessing a patient’s congestion levels. The CPM device measurements of congestion will be compared with established measures of congestion such as physical examination, blood tests, lung function tests, echocardiography and lung ultrasound.
This is an observational study that will not influence the medical care the participants receive. 100 participants
will be enrolled. 20 patients will be recruited at the Scottish National Advanced Heart Failure Unit at the Golden Jubilee National Hospital who are undergoing repeated, clinically indicated right heart catheterisations. This cohort will be assessed on a minimum of two occasions. 40 patients receiving regular (3 times a week) dialysis will be recruited from the dialysis unit at the Queen Elizabeth University Hospital (QEUH). This cohort will be assessed twice on the same day. 40 patients admitted to the QEUH with decompensated heart failure will also be enrolled. This cohort will be assessed 4 times over the course of their admission. A cohort of 3-5 heart failure inpatients at the QEUH will be recruited as a small training cohort for the researchers to become familiar with applying the device and performing device readings. The training cohort will have one device reading only.REC name
London - Dulwich Research Ethics Committee
REC reference
21/LO/0465
Date of REC Opinion
3 Aug 2021
REC opinion
Further Information Favourable Opinion