Comparing PA Compliance During and After Decompensation in HFP

September 9, 2019 updated by: Theranova, L.L.C.

Comparison of Noninvasive Pulmonary Artery Compliance During and After Decompensation in Heart Failure Patients

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diuretics resulting in fluid status changes in severely compensated CHF patients from hospital admit time to discharge and to follow up visit
Time Frame: 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).
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
Time Frame: 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).
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
Time Frame: 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).
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
Time Frame: 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).
Through study completion, up to 1 month depending on readmission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Theranova, L.L.C.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 24, 2019

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

February 1, 2020

Study Registration Dates

First Submitted

April 1, 2019

First Submitted That Met QC Criteria

April 10, 2019

First Posted (Actual)

April 16, 2019

Study Record Updates

Last Update Posted (Actual)

September 10, 2019

Last Update Submitted That Met QC Criteria

September 9, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRD-02-1434

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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