Correlation of the Non-invasive Cardiopulmonary Management (CPM) Wearable Device With Measures of Congestion in Heart Failure (CONGEST HF)

March 30, 2023 updated by: NHS Greater Glasgow and Clyde
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United Kingdom
      • Glasgow, United Kingdom
        • Queen Elizabeth University Hospital
      • Glasgow, United Kingdom, G81 4HX
        • Golden Jubilee National Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with Heart Failure

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Training Cohort
Inpatients with HF requiring >24 hours IV diuretics
Device: non-invasive Cardiopulmonary Management (CPM) wearable device
non-invasive Cardiopulmonary Management (CPM) wearable device with measures of congestion in heart failure
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
non-invasive Cardiopulmonary Management (CPM) wearable device with measures of congestion in heart failure
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
non-invasive Cardiopulmonary Management (CPM) wearable device with measures of congestion in heart failure
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
non-invasive Cardiopulmonary Management (CPM) wearable device with measures of congestion in heart failure

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
3 months
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
4 hours
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
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
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)
24 hours
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
24 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cohort A: 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 pulmonary function measured by the CPM wearable device and spirometry measured by tidal volumes (ml/kg)
24 hours
Cohort B: 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 measured by tidal volumes (ml/kg)
24 hours
Cohort C: 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 measured by tidal volumes (ml/kg)
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 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
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 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
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 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
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 right heart catheter (RHC) measurements
3 months
Cohort A: To determine the correlation between congestion measured by the CPM wearable device and echocardiography
Time Frame: 3 months
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
Cohort B: To determine the correlation between congestion measured by the CPM wearable device and echocardiography
Time Frame: 4 hours
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
Cohort C: To determine the correlation between congestion measured by the CPM wearable device and echocardiography
Time Frame: 24 hours
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

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cohort A: Correlation coefficient between congestion score measured by CPM wearable device and NTproBNP
Time Frame: 3 months
Cohort A: Correlation coefficient between congestion score measured by CPM wearable device and NTproBNP measured in pg/ml
3 months
Cohort B: Correlation coefficient between congestion score measured by CPM wearable device and NTproBNP
Time Frame: 4 hours
Cohort B: Correlation coefficient between congestion score measured by CPM wearable device and NTproBNP measured in pg/ml
4 hours
Cohort C: Correlation coefficient between congestion score measured by CPM wearable device and NTproBNP
Time Frame: 24 hours
Cohort C: Correlation coefficient between congestion score measured by CPM wearable device and NTproBNP measured in pg/ml
24 hours
Cohort A: Correlation coefficient between congestion score measured by CPM wearable device and change in haematocrit (Hct)
Time Frame: 3 months
Cohort A: Correlation coefficient between congestion score measured by CPM wearable device and change in haematocrit (Hct) measured in L/L
3 months
Cohort B: Correlation coefficient between congestion score measured by CPM wearable device and change in haematocrit (Hct)
Time Frame: 4 hours
Cohort B: Correlation coefficient between congestion score measured by CPM wearable device and change in haematocrit (Hct) measured in L/L
4 hours
Cohort C: Correlation coefficient between congestion score measured by CPM wearable device and Change in haematocrit (Hct)
Time Frame: 24 hours
Cohort C: Correlation coefficient between congestion score measured by CPM wearable device and Change in haematocrit (Hct) measured in L/L
24 hours
Cohort C: Correlation coefficient between congestion score measured by CPM wearable device and left ventricular strain
Time Frame: 3 months
Cohort C: Correlation coefficient between congestion score measured by CPM wearable device and left ventricular strain measured in percentage by echocardiography
3 months
Cohort C: Correlation coefficient between congestion score measured by CPM wearable device and right ventricular strain
Time Frame: 4 hours
Cohort C: Correlation coefficient between congestion score measured by CPM wearable device and right ventricular strain measured in percentage by echocardiography
4 hours
Cohort C: Correlation coefficient between congestion score measured by CPM wearable device and left atrial strain
Time Frame: 24 hours
Cohort C: Correlation coefficient between congestion score measured by CPM wearable device and left atrial strain measured in percentage by echocardiography
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
NHS Greater Glasgow and Clyde

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Glasgow

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 23, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 22, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 22, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 23, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 30, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 3, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GN20CA003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

To be determined on completion of recruitment in line with sponsor policy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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