Precision of IMED-4 Lung Fluid Measurements

Study Overview
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Brief Summary
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The purpose of this study is to determine if IMED-4 recordings have sufficient precision to detect a clinically significant change in lung fluid status in acute heart failure syndrome with pulmonary congestion.

Detailed Description
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The study will evaluate if the IMED-4 system has the precision to detect a clinically significant change in lung fluid status for patients with confirmed acute heart failure syndrome with pulmonary congestion. Changes in lung fluid in acute heart failure syndrome are difficult to diagnose and evaluate.

Official Title
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Precision of IMED-4 Lung Fluid Measurements

Conditions
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Dyspnea, Acute Heart Failure Syndrome, Pulmonary Congestion

Intervention / Treatment
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* Device: IMED-4


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Diagnosed with acute heart failure syndrome with pulmonary congestion defined by a Brain natriuretic peptide (BNP) >350 pg/mL or N-terminal pro-brain natriuretic peptide (NT-pro BNP) >1500 pg/mL and any one of the following: PCWP >25mmHg Dyspnea at rest in a recumbent sitting position (30 to 45 degrees), which has worsened within the past week Radiological evidence of CHF on a chest X-ray Physical exam as evidence for pulmonary congestion: i. Presence of an S3 heart sound ii. Lung rales/crackles/crepitations Age greater than or equal to (≥) 18 Ability to reliably carry out self-assessment of symptoms Willingness, ability and commitment to participate in index and follow-up IMED-4 recordings EXCLUSION Criteria Known active myocarditis, obstructive hypertrophic cardiomyopathy, constrictive pericarditis, uncorrected clinically significant primary valvular disease Clinical diagnosis of acute coronary syndrome meeting any 2 of the following 3 criteria: Prolonged chest pain at rest, or an accelerated pattern of angina Electrocardiogram changes indicative of ischemia or myocardial injury Serum troponin >3 times upper limit of lab normal Clinically-suspected acute mechanical cause of ADHF (e.g., papillary muscular rupture); the diagnosis need not be confirmed by imaging or cardiac catheterization Estimated Glomerular Filtration Rate: eGFR <30mL/min/1.73m Known vasculitis, active infective endocarditis, or suspected infections including pneumonia, acute hepatitis, systemic inflammatory response syndrome, or sepsis Body temperature ≥38°C just prior to enrollment Acute or chronic respiratory disorder (e.g. severe chronic obstructive pulmonary disease (COPD)) or primary pulmonary hypertension sufficient to cause dyspnea at rest, which may interfere with the ability to interpret dyspnea assessments or hemodynamic measurements Total Albumin <2.5 g/dL Patients requiring mechanical circulatory support Pregnancy or lactation Patients who have tattoos and/or non-intact skin directly under the electrode sensor position Patients who have had past allergic reactions to medical grade adhesives Patients who have had a lung lobectomy Patients who decline to have their backs photographed with the IMED-4 device in position Severe co-morbidity or poor general physical/mental health that, in the opinion of the Investigator, will not allow the subject to be a good study candidate (i.e. other disease processes, mental capacity, substance abuse, incarceration, shortened life expectance, etc.)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: IMED-4|Non invasive recording electrode used to assess lung fluid|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung Fluid Status | IMED 4 is a new device to measure lung fluid status by assessing how wet or dry the lungs are | Up to 1 year |