Congestive Heart FailureNCT03914222
Comparing PA Compliance During and After Decompensation in HFP
A study testing CardioSpire (Respirix) Device in people with Congestive Heart Failure and Decompensated Heart Failure, run by Theranova, L.L.C. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure, Decompensated Heart Failure
- What is being tested?
- CardioSpire (Respirix) Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jun 2019to Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must ≥ 18 years of age
- Patient has been diagnosed with Congestive Heart Failure, class II-IV
- Patient is currently being admitted for decompensation related to Congestive Heart Failure
- Subject or subject's legally authorized representative is able to give informed consent before entering the study.
Who cannot join
- Currently pregnant or breastfeeding
- Clinical signs or symptoms of a respiratory infection
- Unable to obtain a high-quality signal, as determined by variability of nPAC values throughout a single breath, within 48 hours of enrollment
- Inability to withstand a 10 second end-inspiratory pause, in the opinion of the investigator
- Deemed unsuitable for enrollment in study by the investigator based on subjects' history or physical examination
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Kansas
Kansas City, Kansas, 66160
Kyle Greening, kgreening2@kumc.edu
About this study
Official title: Comparison of Noninvasive Pulmonary Artery Compliance During and After Decompensation in Heart Failure Patients
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.
- Being tested
- CardioSpire (Respirix) Device
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CardioSpire (Respirix) DeviceDevice
Patients will blow into the device through a small tube, which analyzes the signals in the airway patterns.
| Study group | Role | What they receive |
|---|---|---|
| CardioSpire Device | Other | Patients blows into Respirix device or uses BIPAP machine for a few breaths solely to obtain signal. Receives: Device: CardioSpire (Respirix) Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Through study completion, up to 1 month depending on readmission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start24 Jun 2019
- Primary completionDec 2019 (estimated)
- Study completionFeb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Theranova, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03914222
- Sponsor's protocol ID
- CRD-02-1434
- Status last verified
- Apr 2019
- First submitted
- 1 Apr 2019
- Last updated
- 10 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Noninvasive Pulmonary Artery Compliance During and After Decompensation in Heart Failure Patients
- ClinicalTrials.gov ID
- NCT03914222
- Acronym / sponsor ID
- CRD-02-1434
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Theranova, L.L.C.Industry (pharma, biotech, devices)
- Study start
- 24 Jun 2019 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Feb 2020 (estimated)
- First posted
- 16 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CardioSpire Device | Other | Device: CardioSpire (Respirix) DevicePatients blows into Respirix device or uses BIPAP machine for a few breaths solely to obtain signal. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient must ≥ 18 years of age
- Patient has been diagnosed with Congestive Heart Failure, class II-IV
- Patient is currently being admitted for decompensation related to Congestive Heart Failure
- Subject or subject's legally authorized representative is able to give informed consent before entering the study.
Key exclusion criteria (5 listed)
- Currently pregnant or breastfeeding
- Clinical signs or symptoms of a respiratory infection
- Unable to obtain a high-quality signal, as determined by variability of nPAC values throughout a single breath, within 48 hours of enrollment
- Inability to withstand a 10 second end-inspiratory pause, in the opinion of the investigator
- Deemed unsuitable for enrollment in study by the investigator based on subjects' history or physical examination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CardioSpire (Respirix) DevicePatients will blow into the device through a small tube, which analyzes the signals in the airway patterns. | Device | CardioSpire Device |
Primary outcome
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).
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).
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).
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CardioSpire (Respirix) Device in people with Congestive Heart Failure and Decompensated Heart Failure, run by Theranova, L.L.C. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Megan Nolte (4159268616, mnolte@theranova.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2019.