NCT05026034

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2021

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 30, 2021

Completed
24 days until next milestone

Study Start

First participant enrolled

September 23, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 22, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 22, 2022

Completed
Last Updated

April 3, 2023

Status Verified

March 1, 2023

Enrollment Period

10 months

First QC Date

August 23, 2021

Last Update Submit

March 30, 2023

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (10)

  • Cohort A: To determine the correlation between pulmonary function measured by the CPM wearable device and spirometry

    24 hours

  • Cohort B: To determine the correlation between pulmonary function measured by the CPM wearable device and spirometry

    24 hours

  • Cohort C: To determine the correlation between pulmonary function measured by the CPM wearable device and spirometry

    24 hours

  • Cohort A: To determine the correlation between congestion measured by the CPM wearable device and the Everest clinical congestions score

    3 months

  • Cohort B: To determine the correlation between congestion measured by the CPM wearable device and the Everest clinical congestions score

    4 hours

  • +5 more secondary outcomes

Other Outcomes (9)

  • Cohort A: Correlation coefficient between congestion score measured by CPM wearable device and NTproBNP

    3 months

  • Cohort B: Correlation coefficient between congestion score measured by CPM wearable device and NTproBNP

    4 hours

  • Cohort C: Correlation coefficient between congestion score measured by CPM wearable device and NTproBNP

    24 hours

  • +6 more other outcomes

Study Arms (4)

Training Cohort

Inpatients with HF requiring \>24 hours IV diuretics

Device: non-invasive Cardiopulmonary Management (CPM) wearable device

Cohort A

Patients undergoing serial, clinically indicated RHC. To investigate if measures derived by the CPM wearable device correlate with invasive measures of cardiopulmonary haemodynamics (PCWP).

Device: non-invasive Cardiopulmonary Management (CPM) wearable device

Cohort B

Patients receiving haemodialysis. To investigate if changes in measures derived by the CPM wearable device correlate with B-lines on LUS and changes in B-lines before and after haemodialysis and with volume of fluid removed during haemodialysis

Device: non-invasive Cardiopulmonary Management (CPM) wearable device

Cohort C

Patients receiving inpatient intravenous diuretic treatment for heart failure. To investigate if changes in measures derived by the CPM wearable device system correlate with B-lines on lung ultrasound and weight before and after treatment for HF.

Device: non-invasive Cardiopulmonary Management (CPM) wearable device

Interventions

non-invasive Cardiopulmonary Management (CPM) wearable deviceDEVICE

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

Cohort ACohort BCohort CTraining Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with Heart Failure

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Golden Jubilee National Hospital

Glasgow, G81 4HX, United Kingdom

Location

Queen Elizabeth University Hospital

Glasgow, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples will be taken for future cardiac biomarker analysis

MeSH Terms

Conditions

Heart Failure

Interventions

Wearable Electronic Devices

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electrical Equipment and SuppliesEquipment and Supplies

Study Officials

  • Pardeep Jhund

    Glasgow University and NHS Greater Glasgow and Clyde

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2021

First Posted

August 30, 2021

Study Start

September 23, 2021

Primary Completion

July 22, 2022

Study Completion

July 22, 2022

Last Updated

April 3, 2023

Record last verified: 2023-03

Locations

GB(2)