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Comparing PA Compliance During and After Decompensation in HFP

Primary Purpose

Congestive Heart Failure, Decompensated Heart Failure

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CardioSpire (Respirix) Device
Sponsored by
Theranova, L.L.C.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Congestive Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of KansasRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

CardioSpire Device

Arm Description

Patients blows into Respirix device or uses BIPAP machine for a few breaths solely to obtain signal.

Outcomes

Primary Outcome Measures

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).
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).
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).
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).

Secondary Outcome Measures

Full Information

First Posted
April 1, 2019
Last Updated
September 9, 2019
Sponsor
Theranova, L.L.C.
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1. Study Identification

Unique Protocol Identification Number
NCT03914222
Brief Title
Comparing PA Compliance During and After Decompensation in HFP
Official Title
Comparison of Noninvasive Pulmonary Artery Compliance During and After Decompensation in Heart Failure Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 24, 2019 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
February 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Theranova, L.L.C.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure, Decompensated Heart Failure

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CardioSpire Device
Arm Type
Other
Arm Description
Patients blows into Respirix device or uses BIPAP machine for a few breaths solely to obtain signal.
Intervention Type
Device
Intervention Name(s)
CardioSpire (Respirix) Device
Intervention Description
Patients will blow into the device through a small tube, which analyzes the signals in the airway patterns.
Primary Outcome Measure Information:
Title
Diuretics resulting in fluid status changes in severely compensated CHF patients from hospital admit time to discharge and to follow up visit
Description
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).
Time Frame
Through study completion, up to 1 month depending on readmission
Title
Vasoactives resulting in fluid status changes in severely compensated CHF patients from hospital admit time to discharge and to follow up visit
Description
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).
Time Frame
Through study completion, up to 1 month depending on readmission
Title
Fluid status based on weight changes in severely compensated CHF patients from hospital admit time to discharge and to follow up visit
Description
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).
Time Frame
Through study completion, up to 1 month depending on readmission
Title
Clinical congestion measurement changes in severely compensated CHF patients from hospital admit time to discharge and to follow up visit
Description
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).
Time Frame
Through study completion, up to 1 month depending on readmission

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Megan Nolte
Phone
4159268616
Email
mnolte@theranova.com
Facility Information:
Facility Name
University of Kansas
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kyle Greening
Email
kgreening2@kumc.edu

12. IPD Sharing Statement

Learn more about this trial

Comparing PA Compliance During and After Decompensation in HFP

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