Comparing PA Compliance During and After Decompensation in HFP

Congestive Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03914222
• Other study ID #: CRD-02-1434
• Status: Recruiting
• Phase: N/A
• Start date: June 24, 2019
• Est. completion date: February 2020

Study information

• Verified date: April 2019
• Source: Theranova, L.L.C.
• Contact: Megan Nolte
• Phone: 4159268616
• Email: mnolte[@]theranova.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Congestive Heart Failure
• Decompensated Heart Failure
• Heart Failure

Intervention

Device:
• CardioSpire (Respirix) Device
Patients will blow into the device through a small tube, which analyzes the signals in the airway patterns.

Locations

Country	Name	City	State
United States	University of Kansas	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Theranova, L.L.C.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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