Comparing PA Compliance During and After Decompensation in HFP

Not Applicable

• Conditions: Congestive Heart Failure; Decompensated Heart Failure
• Interventions: Device: CardioSpire (Respirix) Device

• Registration Number: NCT03914222
• Lead Sponsor: Theranova, L.L.C.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-04
• Study First Submitted: 2019-04-01
• Study First Submitted QC: 2019-04-10
• Study First Posted: 2019-04-16
• Study Start: 2019-06-24
• Last Update Submitted: 2019-09-09
• Last Update Posted: 2019-09-10
• Primary Completion: 2019-12
• Study Completion: 2020-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CardioSpire Device	CardioSpire (Respirix) Device	Patients blows into Respirix device or uses BIPAP machine for a few breaths solely to obtain signal.

Primary Outcome Measures

Name	Time	Method
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).
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).
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).

Trial Locations

Locations (1)

University of Kansas; 🇺🇸 Kansas City, Kansas, United States