Comparing PA Compliance During and After Decompensation in HFP

• Sponsor: Theranova, L.L.C. (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT03914222
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 7.3
• Patients Per Site Per Month: 8.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Congestive Heart Failure; Decompensated Heart Failure	Device: CardioSpire (Respirix) Device	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Comparison of Noninvasive Pulmonary Artery Compliance During and After Decompensation in Heart Failure Patients
• Actual Study Start Date: Jun 24, 2019
• Anticipated Primary Completion Date: Dec 1, 2019
• Anticipated Study Completion Date: Feb 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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).

2. 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).

3. 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).

4. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Kansas	Kansas City	Kansas	United States	66160

Sponsors and Collaborators

• Theranova, L.L.C.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Theranova, L.L.C.
• ClinicalTrials.gov Identifier: NCT03914222
• Other Study ID Numbers: CRD-02-1434
• First Posted: Apr 16, 2019
• Last Update Posted: Sep 10, 2019
• Last Verified: Apr 1, 2019

• 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
• Additional relevant MeSH terms: Heart Failure

Study Results

No Results Posted as of Sep 10, 2019