Heart FailureCONGEST HFNCT05026034
Correlation of the Non-invasive Cardiopulmonary Management (CPM) Wearable Device With Measures of Congestion in Heart Failure
An observational study of Heart Failure, run by NHS Greater Glasgow and Clyde at 2 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- non-invasive Cardiopulmonary Management (CPM) wearable device
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 72 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 23 Sep 2021to 22 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Heart Failure
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Golden Jubilee National Hospital
Glasgow, G81 4HX
Queen Elizabeth University Hospital
Glasgow
About this study
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.
Read the detailed 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.
- Conditions
- Heart Failure
- Being tested
- non-invasive Cardiopulmonary Management (CPM) wearable device
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-invasive Cardiopulmonary Management (CPM) wearable deviceDevice
non-invasive Cardiopulmonary Management (CPM) wearable device with measures of congestion in heart failure
| Study group | Role | What they receive |
|---|---|---|
| Training Cohort | Inpatients with HF requiring >24 hours IV diuretics Receives: 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). Receives: 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 Receives: 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. Receives: Device: non-invasive Cardiopulmonary Management (CPM) wearable device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 24 hours
Secondary outcomes (10)
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)
Measured: 24 hours
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)
Measured: 24 hours
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)
Measured: 24 hours
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)
Measured: 3 months
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)
Measured: 4 hours
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)
Measured: 24 hours
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
Measured: 3 months
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
Measured: 3 months
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
Measured: 4 hours
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
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start23 Sep 2021
- Primary completion22 Jul 2022
- Study completion22 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- University of Glasgow
- Responsible party
- Sponsor
- Investigators
- Pardeep Jhund, Principal investigator, Glasgow University and NHS Greater Glasgow and Clyde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05026034
- Sponsor's protocol ID
- GN20CA003
- Acronym
- CONGEST HF
- Status last verified
- Mar 2023
- First submitted
- 23 Aug 2021
- Last updated
- 3 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: To be determined on completion of recruitment in line with sponsor policy
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of the Non-invasive Cardiopulmonary Management (CPM) Wearable Device With Measures of Congestion in Heart Failure
- ClinicalTrials.gov ID
- NCT05026034
- Acronym / sponsor ID
- CONGEST HF / GN20CA003
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- University of Glasgow
- Study start
- 23 Sep 2021 (actual)
- Primary completion
- 22 Jul 2022 (actual)
- Study completion
- 22 Jul 2022 (actual)
- First posted
- 30 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Training Cohort | – | Device: non-invasive Cardiopulmonary Management (CPM) wearable deviceInpatients with HF requiring >24 hours IV diuretics |
| Cohort A | – | Device: non-invasive Cardiopulmonary Management (CPM) wearable devicePatients undergoing serial, clinically indicated RHC. To investigate if measures derived by the CPM wearable device correlate with invasive measures of cardiopulmonary haemodynamics (PCWP). |
| Cohort B | – | Device: non-invasive Cardiopulmonary Management (CPM) wearable devicePatients 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 |
| Cohort C | – | Device: non-invasive Cardiopulmonary Management (CPM) wearable devicePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Heart Failure
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non-invasive Cardiopulmonary Management (CPM) wearable devicenon-invasive Cardiopulmonary Management (CPM) wearable device with measures of congestion in heart failure | Device | Cohort A, Cohort B, Cohort C, Training Cohort |
Primary outcome
Cohort A: determine the correlation between congestion measured by the CPM wearable device and pulmonary capillary wedge pressure
Time frame: 3 months
Cohort A: determine the correlation between congestion measured by the CPM wearable device and pulmonary capillary wedge pressure measured in mmHg
Cohort B: To determine the correlation between congestion and change in congestion measured by the CPM wearable device and lung ultrasound (LUS)
Time frame: 4 hours
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
Cohort B: To determine the correlation between congestion and change in congestion measured by the CPM wearable device and lung ultrasound (LUS)
Time frame: 4 hours
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
Cohort C: To determine the correlation between congestion and change in congestion measured by the CPM wearable device and clinical measures of congestion
Time frame: 24 hours
Cohort C: To determine the correlation between congestion and change in congestion measured by the CPM wearable device and change in weight (kg)
Cohort C: To determine the correlation between congestion and change in congestion measured by the CPM wearable device and lung ultrasound (LUS)
Time frame: 24 hours
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
10 secondary outcomes
Cohort A: To determine the correlation between pulmonary function measured by the CPM wearable device and spirometry
Time frame: 24 hours
Cohort B: To determine the correlation between pulmonary function measured by the CPM wearable device and spirometry
Time frame: 24 hours
Cohort C: To determine the correlation between pulmonary function measured by the CPM wearable device and spirometry
Time frame: 24 hours
Cohort A: To determine the correlation between congestion measured by the CPM wearable device and the Everest clinical congestions score
Time frame: 3 months
Cohort B: To determine the correlation between congestion measured by the CPM wearable device and the Everest clinical congestions score
Time frame: 4 hours
Cohort C: To determine the correlation between congestion measured by the CPM wearable device and the Everest clinical congestions score
Time frame: 24 hours
Cohort A: To determine the correlation between congestion measured by the CPM wearable device and right heart catheter (RHC) measurements
Time frame: 3 months
Cohort A: To determine the correlation between congestion measured by the CPM wearable device and echocardiography
Time frame: 3 months
Cohort B: To determine the correlation between congestion measured by the CPM wearable device and echocardiography
Time frame: 4 hours
Cohort C: To determine the correlation between congestion measured by the CPM wearable device and echocardiography
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2023.
- Individual participant dataSharing planned: Undecided. To be determined on completion of recruitment in line with sponsor policy
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pardeep Jhund principal investigator
Glasgow University and NHS Greater Glasgow and Clyde
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by NHS Greater Glasgow and Clyde at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cohort A: determine the correlation between congestion measured by the CPM wearable device and pulmonary capillary wedge pressure (time frame: 3 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2023.