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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05026034
Other study ID # GN20CA003
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 23, 2021
Est. completion date July 22, 2022

Study information

Verified date March 2023
Source NHS Greater Glasgow and Clyde
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Fluid status and congestion can be determined by the CPM wearable device and correlates with invasive measures, non-invasive measures and biochemical markers of congestion and changes in congestion.


Description:

HF is associated with frequent and lengthy hospitalisations. These hospitalisations are usually as a result of congestion. The signs of congestion that can be recognised by physicians or health care professionals such as lung crackles or worsening of peripheral oedema are often seen at a late stage before an intervention can be made to prevent overt decompensation and admission to hospital. 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 single, non-invasive device would potentially provide a useful tool for assessing a patient's congestion levels and allow patients with progressive deterioration to be identified earlier.


Recruitment information / eligibility

Status Completed
Enrollment 72
Est. completion date July 22, 2022
Est. primary completion date July 22, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: Written informed consent - Male or female over18 years of age Cohort A - Meet European Society of Cardiology 1 (ESC) criteria for diagnosis of HF - Undergoing clinically-indicated RHC Cohort B - Established on haemodialysis for >90 days - Undergoing haemodialysis with target volume removal =1.5 litres fluid Cohort C - Meet ESC criteria for diagnosis of HF including heart failure - Requiring treatment with intravenous (IV) diuretics Training Cohort - Meet ESC criteria for diagnosis of HF including heart failure - Requiring treatment with intravenous (IV) diuretics Exclusion Criteria: - Unable to consent to inclusion in study due to cognitive impairment - Allergies or skin sensitivities to silicone-based adhesive - Skin breakdown or dermatological condition on the left chest or breast areas or chest wall deformity where the device is placed - Pregnancy or breast-feeding - Conditions that may confound congestion assessments - COVID-19 infection.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
non-invasive Cardiopulmonary Management (CPM) wearable device
non-invasive Cardiopulmonary Management (CPM) wearable device with measures of congestion in heart failure

Locations

Country Name City State
United Kingdom Golden Jubilee National Hospital Glasgow
United Kingdom Queen Elizabeth University Hospital Glasgow

Sponsors (2)

Lead Sponsor Collaborator
NHS Greater Glasgow and Clyde University of Glasgow

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Other Cohort A: Correlation coefficient between congestion score measured by CPM wearable device and NTproBNP Cohort A: Correlation coefficient between congestion score measured by CPM wearable device and NTproBNP measured in pg/ml 3 months
Other Cohort B: Correlation coefficient between congestion score measured by CPM wearable device and NTproBNP Cohort B: Correlation coefficient between congestion score measured by CPM wearable device and NTproBNP measured in pg/ml 4 hours
Other Cohort C: Correlation coefficient between congestion score measured by CPM wearable device and NTproBNP Cohort C: Correlation coefficient between congestion score measured by CPM wearable device and NTproBNP measured in pg/ml 24 hours
Other Cohort A: Correlation coefficient between congestion score measured by CPM wearable device and change in haematocrit (Hct) Cohort A: Correlation coefficient between congestion score measured by CPM wearable device and change in haematocrit (Hct) measured in L/L 3 months
Other Cohort B: Correlation coefficient between congestion score measured by CPM wearable device and change in haematocrit (Hct) Cohort B: Correlation coefficient between congestion score measured by CPM wearable device and change in haematocrit (Hct) measured in L/L 4 hours
Other Cohort C: Correlation coefficient between congestion score measured by CPM wearable device and Change in haematocrit (Hct) Cohort C: Correlation coefficient between congestion score measured by CPM wearable device and Change in haematocrit (Hct) measured in L/L 24 hours
Other Cohort C: Correlation coefficient between congestion score measured by CPM wearable device and left ventricular strain Cohort C: Correlation coefficient between congestion score measured by CPM wearable device and left ventricular strain measured in percentage by echocardiography 3 months
Other Cohort C: Correlation coefficient between congestion score measured by CPM wearable device and right ventricular strain Cohort C: Correlation coefficient between congestion score measured by CPM wearable device and right ventricular strain measured in percentage by echocardiography 4 hours
Other Cohort C: Correlation coefficient between congestion score measured by CPM wearable device and left atrial strain Cohort C: Correlation coefficient between congestion score measured by CPM wearable device and left atrial strain measured in percentage by echocardiography 24 hours
Primary Cohort A: determine the correlation between congestion measured by the CPM wearable device and pulmonary capillary wedge pressure Cohort A: determine the correlation between congestion measured by the CPM wearable device and pulmonary capillary wedge pressure measured in mmHg 3 months
Primary Cohort B: To determine the correlation between congestion and change in congestion measured by the CPM wearable device and lung ultrasound (LUS) Cohort B: To determine the correlation between congestion and change in congestion measured by the CPM wearable device and lung ultrasound (LUS) measured as change in number of B lines 4 hours
Primary Cohort B: To determine the correlation between congestion and change in congestion measured by the CPM wearable device and lung ultrasound (LUS) Cohort B: To determine the correlation between congestion and change in congestion measured by the CPM wearable device and volume of fluid removed by dialysis in mls 4 hours
Primary Cohort C: To determine the correlation between congestion and change in congestion measured by the CPM wearable device and clinical measures of congestion Cohort C: To determine the correlation between congestion and change in congestion measured by the CPM wearable device and change in weight (kg) 24 hours
Primary Cohort C: To determine the correlation between congestion and change in congestion measured by the CPM wearable device and lung ultrasound (LUS) Cohort C: To determine the correlation between congestion and change in congestion measured by the CPM wearable device and lung ultrasound (LUS) measured as change in number of B lines 24 hours
Secondary Cohort A: To determine the correlation between pulmonary function measured by the CPM wearable device and spirometry Cohort A: To determine the correlation between pulmonary function measured by the CPM wearable device and spirometry measured by tidal volumes (ml/kg) 24 hours
Secondary Cohort B: To determine the correlation between pulmonary function measured by the CPM wearable device and spirometry Cohort B: To determine the correlation between pulmonary function measured by the CPM wearable device and spirometry measured by tidal volumes (ml/kg) 24 hours
Secondary Cohort C: To determine the correlation between pulmonary function measured by the CPM wearable device and spirometry Cohort C: To determine the correlation between pulmonary function measured by the CPM wearable device and spirometry measured by tidal volumes (ml/kg) 24 hours
Secondary Cohort A: To determine the correlation between congestion measured by the CPM wearable device and the Everest clinical congestions score Cohort A: To determine the correlation between congestion measured by the CPM wearable device and the Everest clinical congestions score grading 0 to 3 (with 0 being absent or a trace) 3 months
Secondary Cohort B: To determine the correlation between congestion measured by the CPM wearable device and the Everest clinical congestions score Cohort B: To determine the correlation between congestion measured by the CPM wearable device and the Everest clinical congestions score grading 0 to 3 (with 0 being absent or a trace) 4 hours
Secondary Cohort C: To determine the correlation between congestion measured by the CPM wearable device and the Everest clinical congestions score Cohort C: To determine the correlation between congestion measured by the CPM wearable device and the Everest clinical congestions score grading 0 to 3 (with 0 being absent or a trace) 24 hours
Secondary Cohort A: To determine the correlation between congestion measured by the CPM wearable device and right heart catheter (RHC) measurements Cohort A: To determine the correlation between congestion measured by the CPM wearable device and right heart catheter (RHC) measurements 3 months
Secondary Cohort A: To determine the correlation between congestion measured by the CPM wearable device and echocardiography Cohort A: To determine the correlation between congestion measured by the CPM wearable device and left ventricular ejection fraction (LVEF) measured as a percentrage by echocardiography 3 months
Secondary Cohort B: To determine the correlation between congestion measured by the CPM wearable device and echocardiography Cohort B: To determine the correlation between congestion measured by the CPM wearable device and left ventricular ejection fraction (LVEF) measured as a percentrage by echocardiography 4 hours
Secondary Cohort C: To determine the correlation between congestion measured by the CPM wearable device and echocardiography Cohort C: To determine the correlation between congestion measured by the CPM wearable device and left ventricular ejection fraction (LVEF) measured as a percentrage by echocardiography 24 hours
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