Comparing PA Compliance During and After Decompensation in HFP

Theranova, L.L.C.60 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Congestive Heart Failure Decompensated Heart Failure

Interventions

CardioSpire (Respirix) DeviceDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Kansas

Kansas City, Kansas, United States

RECRUITING

Outcomes

Primary Outcomes

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).

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

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).

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

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).

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

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).

Time frame: Through study completion, up to 1 month depending on readmission

Central Contacts

Megan Nolte

CONTACT

4159268616 mnolte@theranova.com

Data from ClinicalTrials.gov

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