Congestive Heart Failure(CHF)EaseNCT02369042
KYMA Device: External Measure of Thoracic Fluid and Vital Signs
A study testing Kyma Device u-Cor System in people with Congestive Heart Failure(CHF), run by The Christ Hospital at 1 site in United States.
Trial summary
External measure of thoracic fluid content (TFC) combined with vital signs (HR,respiratory rate(RR), posture and movements) using the technology developed by Kyma Medical Technologies while tracking clinical changes in acute in-hospital and chronic outpatient heart failure patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure(CHF)
- What is being tested?
- Kyma Device u-Cor System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to 19 Apr 2017
- 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
- Cohort I
- Men or women over 18 years of age
- Admitted for primary diagnosis of HF
- Already assigned for indwelling PA catheter monitoring
- BNP > 400
- Two of the following: edema, JVP>7cm, rales
Show all 13Show fewer
- Currently being assessed with clinically indicated hemodynamic monitoring
- Cohort II
- Men or women over 18 years of age
- Admitted with the primary diagnosis of HF
- BNP > 400
- Two of the following: edema, JVP> 7cm, rales
- Patients with or without hemodynamic monitoring in use
Who cannot join
- Cohort I and II
- Patients with allergies or skin sensitivities to electrode hydrogel and/or acrylic based adhesive
- Pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site
The Lindner Research Center at The Christ Hospitak
Cincinnati, Ohio, 45219
About this study
External measure of thoracic fluid content (TFC) combined with vital signs (HR,respiratory rate(RR), posture and movements) using the technology developed by Kyma Medical Technologies while tracking clinical changes in acute in-hospital and chronic outpatient heart failure patients.
Read the detailed description
This is a prospective, single center, non-randomized study designed to correlate Kyma measurements and in-hospital parameters as well as the changes in TFC and vital signs with clinical changes in the outpatient setting for 60 days post-discharge. The patient and hospital study personnel will be blinded to the Kyma data captured by the device. No intervention will be performed on the patient based on the Kyma device data, this is an observational study.
The goals of the study are:
- Follow thoracic fluid and vital signs in acute, hospitalized heart failure(HF) patients with evidence of volume overload to evaluate this combined parameter in relation to decongestion (time to clear lung auscultation or clearing of congestion on chest x-ray or decrease in BNP by 50%), clinical symptoms, physical exam, and biomarker results.
- Evaluate the relationship between lung decongestion as externally measured and hemodynamic parameters as measured by pulmonary artery catheter in a subset of patients
- Correlate changes in thoracic fluid content and vital signs with clinical changes in the outpatient setting for 60 days post-discharge.
- Evaluate the feasibility of implementing a physician-directed, patient- managed model of diuretic and vasodilator adjustment.
Patients will be approached for enrollment within 24 hours of presentation to the hospital. The Kyma device will be applied to the patient. Data will be automatically collected by the device: TFC will be measured every 30 minutes and vital signs will be measured several times an hour.
Information collected at baseline by the study coordinators will include medications, lab work (CBC, Chemistry, BNP), ejection fraction(EF), weight, vital signs, and lung auscultation for both Cohorts.
Cohorts I and II may be enrolled concurrently. For patients enrolled in Cohort I, PA readings will be recorded at baseline and 3 times daily until the pulmonary artery(PA) catheter is removed.
While hospitalized, all patients will have daily weights, intake/output, Physical Exams(edema, jugular venous distention(JVP), lung exam) and vital signs will be recorded twice daily. Lab results will be recorded as well as any changes in medication.
After hospital discharge, the patients will wear the Kyma device for an additional 60 days. Patients will be contacted by telephone at 10 days, 30 days, and 60 days post-discharge for weight measurements, medication changes, and assessment of any Office Visits, or ER/Hospitalizations for SOB.
The Minnesota Living with Heart Failure Questionnaire will be administered at hospital discharge and 30 and 60 days post-discharge.
- Conditions
- Congestive Heart Failure(CHF)
- Being tested
- Kyma Device u-Cor System
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kyma Device u-Cor SystemDevice
The Kyma uCor system externally measures thoracic fluid content, heart rate, respiratory rate, posture and movement. The system includes a flat antenna that is attached to the patient's torso with a bandage-like sticker. The antenna transmits radio waves and receives their reflections from the body for several seconds every few hours throughout the day.The data is recorded and collected then compared to traditional clinical parameters.
| Study group | Role | What they receive |
|---|---|---|
| Cohort I | Experimental | Patients admitted with the primary diagnosis of HF and are currently being assessed with clinically indicated hemodynamic monitoring.The Kyma device will be worn by the patient and data collected from the device will be compared to the data collected through hemodynamic monitoring. The device will be worn for 60 days post hospital discharge. Receives: Device: Kyma Device u-Cor System |
| Cohort II | Experimental | Patients admitted with the primary diagnosis of HF and are being assessed with or without hemodynamic monitoring. The Kyma device will be worn by the patient and data collected from the device will be compared to the data collected while the patient is hospitalized. The device will be worn for 60 days post hospital discharge. Receives: Device: Kyma Device u-Cor System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validate the ability of externally monitored thoracic fluid content as a measure of HF.
Accomplished by comparing the data measured by the Kyma Device(HR, RR, thoracic fluid content) with the same clinical data collected while in the hospital.
Measured: 60 days
Secondary outcomes (1)
Assess the effectiveness of remote monitoring in detecting outpatient decompensation.
Compare the data collected by the Kyma Device (HR, RR, movement, thoracic fluid content) to any clinical changes related to HF in the outpatient setting.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2015 (estimated)
- Study startOct 2014
- Primary completion20 Mar 2016
- Study completion19 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart Failure(CHF)Studies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Christ Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Eugene Chung, The Christ Hospital
- Investigators
- Eugene Chung, MD, Principal investigator, The Lindner Research Center at The Christ Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02369042
- Sponsor's protocol ID
- ChristH
- Acronym
- Ease
- Status last verified
- Feb 2015
- First submitted
- 28 Oct 2014
- Last updated
- 19 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KYMA Device: External Measure of Thoracic Fluid and Vital Signs
- ClinicalTrials.gov ID
- NCT02369042
- Acronym / sponsor ID
- Ease / ChristH
- Conditions
- Congestive Heart Failure(CHF)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- The Christ HospitalUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- 20 Mar 2016 (actual)
- Study completion
- 19 Apr 2017 (actual)
- First posted
- 23 Feb 2015 (estimated)
- 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.
External measure of thoracic fluid content (TFC) combined with vital signs (HR,respiratory rate(RR), posture and movements) using the technology developed by Kyma Medical Technologies while tracking clinical changes in acute in-hospital and chronic outpatient heart failure patients.
Detailed description
This is a prospective, single center, non-randomized study designed to correlate Kyma measurements and in-hospital parameters as well as the changes in TFC and vital signs with clinical changes in the outpatient setting for 60 days post-discharge. The patient and hospital study personnel will be blinded to the Kyma data captured by the device. No intervention will be performed on the patient based on the Kyma device data, this is an observational study.
The goals of the study are:
- Follow thoracic fluid and vital signs in acute, hospitalized heart failure(HF) patients with evidence of volume overload to evaluate this combined parameter in relation to decongestion (time to clear lung auscultation or clearing of congestion on chest x-ray or decrease in BNP by 50%), clinical symptoms, physical exam, and biomarker results.
- Evaluate the relationship between lung decongestion as externally measured and hemodynamic parameters as measured by pulmonary artery catheter in a subset of patients
- Correlate changes in thoracic fluid content and vital signs with clinical changes in the outpatient setting for 60 days post-discharge.
- Evaluate the feasibility of implementing a physician-directed, patient- managed model of diuretic and vasodilator adjustment.
Patients will be approached for enrollment within 24 hours of presentation to the hospital. The Kyma device will be applied to the patient. Data will be automatically collected by the device: TFC will be measured every 30 minutes and vital signs will be measured several times an hour.
Information collected at baseline by the study coordinators will include medications, lab work (CBC, Chemistry, BNP), ejection fraction(EF), weight, vital signs, and lung auscultation for both Cohorts.
Cohorts I and II may be enrolled concurrently. For patients enrolled in Cohort I, PA readings will be recorded at baseline and 3 times daily until the pulmonary artery(PA) catheter is removed.
While hospitalized, all patients will have daily weights, intake/output, Physical Exams(edema, jugular venous distention(JVP), lung exam) and vital signs will be recorded twice daily. Lab results will be recorded as well as any changes in medication.
After hospital discharge, the patients will wear the Kyma device for an additional 60 days. Patients will be contacted by telephone at 10 days, 30 days, and 60 days post-discharge for weight measurements, medication changes, and assessment of any Office Visits, or ER/Hospitalizations for SOB.
The Minnesota Living with Heart Failure Questionnaire will be administered at hospital discharge and 30 and 60 days post-discharge.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort I | Experimental | Device: Kyma Device u-Cor SystemPatients admitted with the primary diagnosis of HF and are currently being assessed with clinically indicated hemodynamic monitoring.The Kyma device will be worn by the patient and data collected from the device will be compared to the data collected through hemodynamic monitoring. The device will be worn for 60 days post hospital discharge. |
| Cohort II | Experimental | Device: Kyma Device u-Cor SystemPatients admitted with the primary diagnosis of HF and are being assessed with or without hemodynamic monitoring. The Kyma device will be worn by the patient and data collected from the device will be compared to the data collected while the patient is hospitalized. The device will be worn for 60 days post hospital discharge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Cohort I
- Cohort II
- Men or women over 18 years of age
- Admitted with the primary diagnosis of HF
- BNP > 400
Key exclusion criteria (3 listed)
- Cohort I and II
- Patients with allergies or skin sensitivities to electrode hydrogel and/or acrylic based adhesive
- Pregnant women
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 |
|---|---|---|
| Kyma Device u-Cor SystemThe Kyma uCor system externally measures thoracic fluid content, heart rate, respiratory rate, posture and movement. The system includes a flat antenna that is attached to the patient's torso with a bandage-like sticker. The antenna transmits radio waves and receives their reflections from the body for several seconds every few hours throughout the day.The data is recorded and collected then compared to traditional clinical parameters. | Device | Cohort I, Cohort II |
Primary outcome
Validate the ability of externally monitored thoracic fluid content as a measure of HF.
Time frame: 60 days
Accomplished by comparing the data measured by the Kyma Device(HR, RR, thoracic fluid content) with the same clinical data collected while in the hospital.
1 secondary outcome
Assess the effectiveness of remote monitoring in detecting outpatient decompensation.
Time frame: 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2017.
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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.
Eugene Chung, MD principal investigator
The Lindner Research Center at The Christ Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kyma Device u-Cor System in people with Congestive Heart Failure(CHF), run by The Christ Hospital 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 13 inclusion and 3 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: finished, as of the sponsor's last update on 19 Jul 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validate the ability of externally monitored thoracic fluid content as a measure of HF. (time frame: 60 days). 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 19 Jul 2017.