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Comparing PA Compliance During and After Decompensation in HFP

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03914222
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : September 10, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Congestive Heart Failure Decompensated Heart Failure Device: CardioSpire (Respirix) Device Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : June 24, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
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.




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 [ 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).

  2. 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).

  3. 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).

  4. 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03914222


Contacts
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Contact: Megan Nolte 4159268616 mnolte@theranova.com

Locations
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United States, Kansas
University of Kansas Recruiting
Kansas City, Kansas, United States, 66160
Contact: Kyle Greening       kgreening2@kumc.edu   
Sponsors and Collaborators
Theranova, L.L.C.
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Responsible Party: Theranova, L.L.C.
ClinicalTrials.gov Identifier: NCT03914222    
Other Study ID Numbers: CRD-02-1434
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: April 2019

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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:
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Heart Failure
Heart Diseases
Cardiovascular Diseases