Recruiting

Observational Study

Sponsor:

Theranova, L.L.C.

Code:

NCT03914222

Conditions

Congestive Heart Failure

Decompensated Heart Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CardioSpire (Respirix) Device

Study Details

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

Study ID

NCT03914222

Start date

Jun 24, 2019

Status verified date

Apr, 2019

Completion date

Feb, 2020

Anticipated

Primary completion date

Dec, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

other: CardioSpire Device

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

Interventions

CardioSpire (Respirix) Device

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

Primary outcome measure

  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Megan Nolte

4159268616mnolte@theranova.com

Locations

University of Kansas

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Kyle Greening

kgreening2@kumc.edu

More Information

Sponsor

Theranova, L.L.C.

Last update posted

Sep 10, 2019

Last verified

Apr, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Theranova, L.L.C. on 2019-09-10.