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Completed

NCT Number: NCT05026034

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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Golden Jubilee National Hospital, Glasgow, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

non-invasive Cardiopulmonary Management (CPM) wearable device

Device

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

Primary outcomes

  1. 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

  2. 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

  3. 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. 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)

  5. 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

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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

  8. 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

  9. 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

  10. 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

Other outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

Sponsors and collaborators

Lead sponsor

NHS Greater Glasgow and Clyde

Other

Collaborators

  • University of Glasgow

Registry information

Acronym: CONGEST HF

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 30, 2021
Registry last updated
Apr 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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