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Correlation of Non-invasive CPM Wearable Device With Measures of Congestion in Heart Failure in Exercise
RECRUITINGSponsored by NHS Greater Glasgow and Clyde
Actively Recruiting
SponsorNHS Greater Glasgow and Clyde
Started2024-03-22
Est. completion2025-02-06
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06393842
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.
Eligibility
Age: 18 Years+Healthy volunteers accepted
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
Conditions2
Heart DiseaseHeart Failure
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Actively Recruiting
SponsorNHS Greater Glasgow and Clyde
Started2024-03-22
Est. completion2025-02-06
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06393842