Comparing PA Compliance During and After Decompensation in HFP

NCT03914222 | Unknown FDA Device

• 1 other identifier: CRD-02-1434
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Congestive Heart Failure; Decompensated Heart Failure

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

CardioSpire Device

OTHER

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

Device: CardioSpire (Respirix) Device

Interventions

CardioSpire (Respirix) Device DEVICE

Patients will blow into the device through a small tube, which analyzes the signals in the airway patterns.

CardioSpire Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Theranova, L.L.C.: lead

Study Sites (1)

University of Kansas

Kansas City, Kansas, 66160, United States

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Megan Nolte

CONTACT

4159268616; mnolte@theranova.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2019
• First Posted: April 16, 2019
• Study Start: June 24, 2019
• Primary Completion: December 1, 2019
• Study Completion: February 1, 2020
• Last Updated: September 10, 2019

Record last verified: 2019-04

Locations

US (1)