Congestive Heart Failure, Decompensated Heart Failure
Conditions
Brief summary
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.
Interventions
DEVICECardioSpire (Respirix) Device
Patients will blow into the device through a small tube, which analyzes the signals in the airway patterns.
Sponsors
Theranova, L.L.C.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient must ≥ 18 years of age 2. Patient has been diagnosed with Congestive Heart Failure, class II-IV 3. Patient is currently being admitted for decompensation related to Congestive Heart Failure 4. Subject or subject's legally authorized representative is able to give informed consent before entering the study.
Exclusion criteria
1. Currently pregnant or breastfeeding 2. Clinical signs or symptoms of a respiratory infection 3. Unable to obtain a high-quality signal, as determined by variability of nPAC values throughout a single breath, within 48 hours of enrollment 4. Inability to withstand a 10 second end-inspiratory pause, in the opinion of the investigator 5. Deemed unsuitable for enrollment in study by the investigator based on subjects' history or physical examination
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fluid status based on weight changes in severely compensated CHF patients from hospital admit time to discharge and to follow up visit | Through study completion, up to 1 month depending on readmission | 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). |
| Diuretics resulting in fluid status changes in severely compensated CHF patients from hospital admit time to discharge and to follow up visit | Through study completion, up to 1 month depending on readmission | 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). |
| Vasoactives resulting in fluid status changes in severely compensated CHF patients from hospital admit time to discharge and to follow up visit | Through study completion, up to 1 month depending on readmission | 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). |
| Clinical congestion measurement changes in severely compensated CHF patients from hospital admit time to discharge and to follow up visit | Through study completion, up to 1 month depending on readmission | 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). |
Countries
United States
Contacts
Primary ContactMegan Nolte
Outcome results
None listed