Heart FailureCONGEST-HFEXNCT06393842
Correlation of Non-invasive CPM Wearable Device With Measures of Congestion in Heart Failure in Exercise
An observational study of Heart Failure, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
Trial summary
Fluid status and congestion can be determined by the CPM wearable device and correlates with 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?
- Cardiopulmonary Management Wearable Device
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Mar 2024to 6 Feb 2026
- 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: Cohort A- Dialysis patients (Inpatients and Outpatients) at the Queen Elizabeth University Hospital, Glasgow Cohort B- Heart Failure Hospitalizations at the Queen Elizabeth University Hospital
Who may be able to join
- Written informed consent Male or female ≥18 years of age
- Cohort A
- Established on hemodialysis for >90 days
- Undergoing hemodialysis with target volume removal ≥1.5 liters fluid
- Cohort B Meet ESC criteria for diagnosis of Heart Failure including
- Heart failure with reduced (HF-REF), mid-range (HF-mREF) and preserved (HF-PEF) ejection fractions
- 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
- Currently uncontrolled cardiac arrhythmia
- Hemodynamically significant mitral stenosis (at least moderate in severity on TTE)
Show all 9Show fewer
- Conditions that may confound congestion assessments including
- Severe obstructive lung disease B. Severe fibrotic lung disease C. Severe liver disease D. Relevant active malignancy E. Active viral or bacterial bronchopneumonia-CXR within 4 weeks showing consolidation F. Pulmonary contusion G. Pneumothorax H. Pneumonectomy I. Lobectomy J. Pulmonary embolism within the previous 3 months K. Indwelling intercostal chest drain L. Left ventricular assist device (LVAD) M. COVID-19 infection. N. Increased Body Mass Index where satisfactory Echocardiographic images not possible
- Cohort B only - inability to perform exercise safely
Trial locations and contacts
1 site in 1 country.
Shivasankar Murugan Sukumar, MBBS, MRCP contact
United Kingdom1 site, 1 recruiting
- Recruiting
Glasgow Cardiovascular Research Centre
Glasgow, Scotland, G12 8TA
Shivasankar Murugan Sukumar, MRCP, 0141 330 2418, Shivasankar.MuruganSukumar@glasgow.ac.uk
About this study
Official title: Correlation of the Non-invasive Cardiopulmonary Management Wearable Device With Measures of Congestion in Heart Failure in Exercise - CONGEST - HF - EX
Fluid status and congestion can be determined by the CPM wearable device and correlates with non-invasive measures and biochemical markers of congestion and changes in congestion.
Read the detailed description
Heart Failure is common, affecting 1-2% of the general population, with the prevalence increasing to over 10% in those over the age of 80. Heart Failure is associated with high morbidity, with many patients requiring frequent and often lengthy hospitalization for treatment with intra venous diuretics. In the recent Heart Failure audit of England and Wales, of over 68000 patients admitted to hospital with a primary diagnosis of Heart Failure between 2017 and 2018, median length of stay was 6-9 days, depending on whether patients were managed by specialist cardiologists. Heart Failure hospitalizations account for approximately 5% of all emergency admissions leading to 2% of all NHS inpatient bed-days. Heart Failure accounts for almost 2% of the total NHS budget, with approximately 70% of these costs due to Heart Failure hospitalizations. The hallmark of decompensation is the development of congestion. This is usually manifested by the development or worsening of pulmonary edema or peripheral edema. Patients often present to hospital when the degree of congestion becomes severe enough to cause symptoms, most often shortness of breath, and therefore require treatment through decongestion with vasodilators and intra venous diuretics. However, a number of studies have shown that the presence of congestion can be detected days to weeks prior to hospitalization leaving a window of opportunity in which treatment aimed at averting a costly hospitalization could occur. Furthermore, congestion can be altered by exercise and may be more pronounced on exercise. Detecting these early signs of congestion has so far only been possible using invasive monitoring devices such as specially designed pacemakers (Heart Logic™, Boston Scientific) or implantable pressure monitors (Cardio MEMS™, Abbott)
Analog Devices Inc have developed a wearable patch-like device called the Cardio- Pulmonary Management (CPM) wearable device which is applied to a patient's chest to assess congestion levels by measuring a number of physiological parameters over approximately five minutes. The goal of this Prospective Uncontrolled Clinical Investigation is to determine if the CPM wearable device can accurately detect the presence of congestion by correlating the findings from the device with changes in congestion status in patients receiving hemodialysis (Cohort A) and if the correlations are different before and after exercise in patients receiving treatment for decongestion for heart failure as an inpatient (Cohort B) as measured by lung spirometry, lung ultrasound Trans Thoracic Echocardiography and Biomarkers
- Conditions
- Heart Failure
- Being tested
- Cardiopulmonary Management Wearable Device
- Keywords
- Pulmonary Congestion
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiopulmonary Management Wearable DeviceDevice
Fluid status and congestion can be determined by the CPM wearable device and correlates with non-invasive measures and biochemical markers of congestion and changes in congestion.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Patients receiving hemodialysis: Primary Objective is to investigate if changes in measures derived by the CPM wearable device correlate with changes in B-lines between dialysis sessions and with the difference in weight between dialysis sessions. The end point would be to demonstrate a change in number of B-Lines on Lung Ultrasound between dialysis sessions and compare it with changes in measures derived by CPM wearable device (thoracic impedance and S3) taken during the same sessions. We would then use correlation coefficient to find how strong a relationship is between measures from Lung Ultrasound and CPM wearable device.
Secondary objective will include correlation of the measures from CPM wearable device with other measures of congestion including Spirometry, Echocardiography, Biomarkers and Physical symptoms and signs including EVEREST and ASCEND congestion score Receives: Device: Cardiopulmonary Management Wearable Device | |
| Cohort B | Primary Objective- Patients receiving inpatient intravenous diuretic treatment for heart failure. To investigate if measures derived by the CPM wearable device system correlate with B-lines on lung ultrasound before and after exercise during the treatment for HF. The end point would be to demonstrate a change in number of B-Lines on LUS before and after exercise during decongestion treatment for HF and compare it with measures derived by CPM wearable device (thoracic impedance and S3) taken during the same sessions. We would then use correlation coefficient to find how strong a relationship is between measures from LUS and CPM wearable device and whether the correlation improved following exercise.
Secondary objective will include correlation of the measures from CPM wearable device with other measures of congestion including Spirometry, Echocardiography, Biomarkers and Physical symptoms and signs including EVEREST and ASCEND congestion score Receives: Device: Cardiopulmonary Management Wearable Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate if changes in measures derived by the CPM wearable device correlate with changes in B-lines between dialysis sessions and with the difference in weight between dialysis sessions.
Correlation of change in congestion measured by the CPM wearable device (thoracic impedance and S3) and change in lung ultrasound (LUS) and weight between the end of the dialysis session and the start of the subsequent dialysis session in patients undergoing two consecutive hemodialysis sessions.
Measured: Between Two Consecutive Dialysis Session (Day 1 and Day 3)
To investigate if measures derived by the CPM wearable device system correlate with B-lines on lung ultrasound before and after exercise during the treatment for HF.
To compare correlations of congestion measured by the CPM wearable device (thoracic impedance and S3) and clinical measures of congestion (LUS) in inpatients with HF obtained before and after exercise
Measured: Data will be gathered at four time points: (1) on the day of enrolment; (2) the day after enrolment; (3) within 24 hours of switch from IV to oral diuretics and; (4) when the patient is as euvolemic as reasonably achievable
Secondary outcomes (2)
To determine the correlation between change in pulmonary function measured by the CPM wearable device and change in pulmonary function measured with spirometry between two consecutive dialysis sessions.
To determine the correlation between change in pulmonary function measured by the CPM device (tidal volume) and pulmonary function measured with spirometry between the end of the dialysis session and the start of the subsequent dialysis session in patients undergoing two consecutive hemodialysis sessions.
To determine the correlation between change in congestion measured by the CPM wearable device (thoracic impedance and S3) and change in clinical measures of congestion [physical symptoms and signs and TTE findings] between the end of the dialysis session and the start of the subsequent dialysis session in patients undergoing two consecutive hemodialysis sessions.
Measured: Between Two Consecutive Dialysis Session (Day 1 and Day 3)
To compare the correlations, before and after exercise, between congestion measured by the CPM wearable device (thoracic impedance and S3) and TTE findings.
The end point would be to demonstrate change in IVC size and change in parameters such as TR Vmax and E/e' on Echocardiography before and after exercise during decongestion treatment for HF and compare it with change in congestion measured by CPM wearable device during the same sessions. We would then use correlation coefficient to find how strong a relationship is between echocardiographic parameters and CPM wearable device.
Measured: Data will be gathered at four time points: (1) on the day of enrolment; (2) the day after enrolment; (3) within 24 hours of switch from IV to oral diuretics and; (4) when the patient is as euvolemic as reasonably achievable
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start22 Mar 2024
- Primary completion6 Feb 2025 (estimated)
- Study completion6 Feb 2026 (estimated)
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- Analog Devices
- Responsible party
- Sponsor
- Investigators
- Pardeep Jhund, FRCP, PhD, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06393842
- Sponsor's protocol ID
- INGN22CA411
- Acronym
- CONGEST-HFEX
- Status last verified
- Apr 2024
- First submitted
- 19 Feb 2024
- Last updated
- 1 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of the Non-invasive Cardiopulmonary Management Wearable Device With Measures of Congestion in Heart Failure in Exercise - CONGEST - HF - EX
- ClinicalTrials.gov ID
- NCT06393842
- Acronym / sponsor ID
- CONGEST-HFEX / INGN22CA411
- Conditions
- Heart Failure
- Keywords
- Pulmonary Congestion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- Analog Devices
- Study start
- 22 Mar 2024 (actual)
- Primary completion
- 6 Feb 2025 (estimated)
- Study completion
- 6 Feb 2026 (estimated)
- First posted
- 1 May 2024 (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 non-invasive measures and biochemical markers of congestion and changes in congestion.
Detailed description
Heart Failure is common, affecting 1-2% of the general population, with the prevalence increasing to over 10% in those over the age of 80. Heart Failure is associated with high morbidity, with many patients requiring frequent and often lengthy hospitalization for treatment with intra venous diuretics. In the recent Heart Failure audit of England and Wales, of over 68000 patients admitted to hospital with a primary diagnosis of Heart Failure between 2017 and 2018, median length of stay was 6-9 days, depending on whether patients were managed by specialist cardiologists. Heart Failure hospitalizations account for approximately 5% of all emergency admissions leading to 2% of all NHS inpatient bed-days. Heart Failure accounts for almost 2% of the total NHS budget, with approximately 70% of these costs due to Heart Failure hospitalizations. The hallmark of decompensation is the development of congestion. This is usually manifested by the development or worsening of pulmonary edema or peripheral edema. Patients often present to hospital when the degree of congestion becomes severe enough to cause symptoms, most often shortness of breath, and therefore require treatment through decongestion with vasodilators and intra venous diuretics. However, a number of studies have shown that the presence of congestion can be detected days to weeks prior to hospitalization leaving a window of opportunity in which treatment aimed at averting a costly hospitalization could occur. Furthermore, congestion can be altered by exercise and may be more pronounced on exercise. Detecting these early signs of congestion has so far only been possible using invasive monitoring devices such as specially designed pacemakers (Heart Logic™, Boston Scientific) or implantable pressure monitors (Cardio MEMS™, Abbott)
Analog Devices Inc have developed a wearable patch-like device called the Cardio- Pulmonary Management (CPM) wearable device which is applied to a patient's chest to assess congestion levels by measuring a number of physiological parameters over approximately five minutes. The goal of this Prospective Uncontrolled Clinical Investigation is to determine if the CPM wearable device can accurately detect the presence of congestion by correlating the findings from the device with changes in congestion status in patients receiving hemodialysis (Cohort A) and if the correlations are different before and after exercise in patients receiving treatment for decongestion for heart failure as an inpatient (Cohort B) as measured by lung spirometry, lung ultrasound Trans Thoracic Echocardiography and Biomarkers
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A | – | Device: Cardiopulmonary Management Wearable DevicePatients receiving hemodialysis: Primary Objective is to investigate if changes in measures derived by the CPM wearable device correlate with changes in B-lines between dialysis sessions and with the difference in weight between dialysis sessions. The end point would be to demonstrate a change in number of B-Lines on Lung Ultrasound between dialysis sessions and compare it with changes in measures derived by CPM wearable device (thoracic impedance and S3) taken during the same sessions. We would then use correlation coefficient to find how strong a relationship is between measures from Lung Ultrasound and CPM wearable device. Secondary objective will include correlation of the measures from CPM wearable device with other measures of congestion including Spirometry, Echocardiography, Biomarkers and Physical symptoms and signs including EVEREST and ASCEND congestion score |
| Cohort B | – | Device: Cardiopulmonary Management Wearable DevicePrimary Objective- Patients receiving inpatient intravenous diuretic treatment for heart failure. To investigate if measures derived by the CPM wearable device system correlate with B-lines on lung ultrasound before and after exercise during the treatment for HF. The end point would be to demonstrate a change in number of B-Lines on LUS before and after exercise during decongestion treatment for HF and compare it with measures derived by CPM wearable device (thoracic impedance and S3) taken during the same sessions. We would then use correlation coefficient to find how strong a relationship is between measures from LUS and CPM wearable device and whether the correlation improved following exercise. Secondary objective will include correlation of the measures from CPM wearable device with other measures of congestion including Spirometry, Echocardiography, Biomarkers and Physical symptoms and signs including EVEREST and ASCEND congestion score |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cohort A- Dialysis patients (Inpatients and Outpatients) at the Queen Elizabeth University Hospital, Glasgow Cohort B- Heart Failure Hospitalizations at the Queen Elizabeth University Hospital
Key inclusion criteria (7 listed)
- Written informed consent Male or female ≥18 years of age
- Cohort A
- Established on hemodialysis for >90 days
- Undergoing hemodialysis with target volume removal ≥1.5 liters fluid
- Cohort B Meet ESC criteria for diagnosis of Heart Failure including
Key exclusion criteria (9 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
- Currently uncontrolled cardiac arrhythmia
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 |
|---|---|---|
| Cardiopulmonary Management Wearable DeviceFluid status and congestion can be determined by the CPM wearable device and correlates with non-invasive measures and biochemical markers of congestion and changes in congestion. | Device | Cohort A, Cohort B |
Primary outcome
To investigate if changes in measures derived by the CPM wearable device correlate with changes in B-lines between dialysis sessions and with the difference in weight between dialysis sessions.
Time frame: Between Two Consecutive Dialysis Session (Day 1 and Day 3)
Correlation of change in congestion measured by the CPM wearable device (thoracic impedance and S3) and change in lung ultrasound (LUS) and weight between the end of the dialysis session and the start of the subsequent dialysis session in patients undergoing two consecutive hemodialysis sessions.
To investigate if measures derived by the CPM wearable device system correlate with B-lines on lung ultrasound before and after exercise during the treatment for HF.
Time frame: Data will be gathered at four time points: (1) on the day of enrolment; (2) the day after enrolment; (3) within 24 hours of switch from IV to oral diuretics and; (4) when the patient is as euvolemic as reasonably achievable
To compare correlations of congestion measured by the CPM wearable device (thoracic impedance and S3) and clinical measures of congestion (LUS) in inpatients with HF obtained before and after exercise
2 secondary outcomes
To determine the correlation between change in pulmonary function measured by the CPM wearable device and change in pulmonary function measured with spirometry between two consecutive dialysis sessions.
Time frame: Between Two Consecutive Dialysis Session (Day 1 and Day 3)
To compare the correlations, before and after exercise, between congestion measured by the CPM wearable device (thoracic impedance and S3) and TTE findings.
Time frame: Data will be gathered at four time points: (1) on the day of enrolment; (2) the day after enrolment; (3) within 24 hours of switch from IV to oral diuretics and; (4) when the patient is as euvolemic as reasonably achievable
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
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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.
Shivasankar Murugan Sukumar, MBBS, MRCP contact
Pardeep Jhund, FRCP, PhD principal investigator
University of Glasgow
1 site 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 1 site 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 7 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shivasankar Murugan Sukumar, MBBS, MRCP (+44 141 330 2677, Shivasankar.MuruganSukumar@glasgow.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To investigate if changes in measures derived by the CPM wearable device correlate with changes in B-lines between dialysis sessions and with the difference in weight between dialysis sessions. (time frame: Between Two Consecutive Dialysis Session (Day 1 and Day 3)). The study lists 2 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 1 May 2024.