Comparing PA Compliance During and After Decompensation in HFP

TheraNova

Status: Unknown

Conditions: Decompensated Heart Failure; Congestive Heart Failure

Treatments: Device: CardioSpire (Respirix) Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT03914222

CRD-02-1434

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

CardioSpire Device

Other group

Description:

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

Treatment:

Device: CardioSpire (Respirix) Device