Comparing PA Compliance During and After Decompensation in HFP

Study Overview
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Brief Summary
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Pulmonary Artery Compliance measurements will be obtained with the Respirix device in patients with congestive heart failure decompensation. Echocardiogram, weight measurements, and BNP will also be gathered as independent measures of decompensation in the clinic. Pulmonary Artery Compliance measurements will be made daily during the hospital stay. Patients can continue using the device at home for the next 3 weeks. Each patient will serve as their own control and relative changes from their baseline will be recorded for each parameter.

Official Title
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Comparison of Noninvasive Pulmonary Artery Compliance During and After Decompensation in Heart Failure Patients

Conditions
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Congestive Heart Failure, Decompensated Heart Failure

Intervention / Treatment
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* Device: CardioSpire (Respirix) Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient must ≥ 18 years of age Patient has been diagnosed with Congestive Heart Failure, class II-IV Patient is currently being admitted for decompensation related to Congestive Heart Failure Subject or subject's legally authorized representative is able to give informed consent before entering the study. Exclusion Criteria: Currently pregnant or breastfeeding Clinical signs or symptoms of a respiratory infection Unable to obtain a high-quality signal, as determined by variability of nPAC values throughout a single breath, within 48 hours of enrollment Inability to withstand a 10 second end-inspiratory pause, in the opinion of the investigator Deemed unsuitable for enrollment in study by the investigator based on subjects' history or physical examination

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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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: CardioSpire Device<br>Patients blows into Respirix device or uses BIPAP machine for a few breaths solely to obtain signal. | Device: CardioSpire (Respirix) Device<br>* Patients will blow into the device through a small tube, which analyzes the signals in the airway patterns.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diuretics resulting in fluid status changes in severely compensated CHF patients from hospital admit time to discharge and to follow up visit | Comparing fluid management (diuretics) to daily CardioSpire's non-invasive Pulmonary Artery Compliance (nPAC) value over the time course from decompensation (at hospital admission) through compensation (discharge) and at their follow up visit, in congestive heart failure patients (CHF). | Through study completion, up to 1 month depending on readmission | 
| Vasoactives resulting in fluid status changes in severely compensated CHF patients from hospital admit time to discharge and to follow up visit | Comparing fluid management (vasoactives) to daily CardioSpire's non-invasive Pulmonary Artery Compliance (nPAC) value over the time course from decompensation (at hospital admission) through compensation (discharge) and at their follow up visit, in congestive heart failure patients (CHF). | Through study completion, up to 1 month depending on readmission | 
| Fluid status based on weight changes in severely compensated CHF patients from hospital admit time to discharge and to follow up visit | Comparing fluid management (through weight changes) to daily CardioSpire's non-invasive Pulmonary Artery Compliance (nPAC) value over the time course from decompensation (at hospital admission) through compensation (discharge) and at their follow up visit, in congestive heart failure patients (CHF). | Through study completion, up to 1 month depending on readmission | 
| Clinical congestion measurement changes in severely compensated CHF patients from hospital admit time to discharge and to follow up visit | Comparing clinical congestion measurement (taken as standard of care) to daily CardioSpire's non-invasive Pulmonary Artery Compliance (nPAC) value over the time course from decompensation (at hospital admission) through compensation (discharge) and at their follow up visit, in congestive heart failure patients (CHF). | Through study completion, up to 1 month depending on readmission |