Using a wearable device to monitor congestion in heart failure patients during exercise
Correlation of the Non-invasive Cardiopulmonary Management Wearable Device With Measures of Congestion in Heart Failure in Exercise - CONGEST - HF - EX
This study is testing a wearable device to see if it can help heart failure patients and those on dialysis monitor fluid buildup during exercise to prevent hospital visits.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | NHS Greater Glasgow and Clyde Academic / other |
| Locations | 1 site (Glasgow, Scotland) |
| Trial ID | NCT06393842 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the correlation between a non-invasive cardiopulmonary management wearable device and various measures of congestion in patients with heart failure. The study will involve two cohorts: one consisting of patients on hemodialysis and the other comprising heart failure patients requiring intravenous diuretics. By monitoring fluid status and congestion, the study seeks to identify early signs of decompensation, potentially allowing for timely interventions to prevent hospitalizations. The methodology includes the use of the wearable device alongside biochemical markers and non-invasive measures to assess congestion levels.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with established heart failure or those on hemodialysis requiring significant fluid removal.
Not a fit: Patients with cognitive impairments, severe lung disease, or significant skin conditions at the device application site may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier interventions for heart failure patients, reducing hospitalizations and improving patient outcomes.
How similar studies have performed: While the use of wearable devices in monitoring heart failure is a growing field, this specific approach is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Written informed consent Male or female ≥18 years of age Cohort A 1. Established on hemodialysis for \>90 days 2. Undergoing hemodialysis with target volume removal ≥1.5 liters fluid Cohort B Meet ESC criteria for diagnosis of Heart Failure including 1. Heart failure with reduced (HF-REF), mid-range (HF-mREF) and preserved (HF-PEF) ejection fractions 2. Requiring treatment with intravenous (IV) diuretics Exclusion Criteria: 1. Unable to consent to inclusion in study due to cognitive impairment 2. Allergies or skin sensitivities to silicone- based adhesive 3. Skin breakdown or dermatological condition on the left chest or breast areas or chest wall deformity where the device is placed 4. Pregnancy or breast-feeding 5. Currently uncontrolled cardiac arrhythmia 6. Hemodynamically significant mitral stenosis (at least moderate in severity on TTE) 7. Conditions that may confound congestion assessments including A. 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
Where this trial is running
Glasgow, Scotland
- Glasgow Cardiovascular Research Centre — Glasgow, Scotland, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Pardeep Jhund, FRCP, PhD — University of Glasgow
- Study coordinator: Shivasankar Murugan Sukumar, MBBS, MRCP
- Email: Shivasankar.MuruganSukumar@glasgow.ac.uk
- Phone: +44 141 330 2677
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.