Heart FailureNCT02190877
Monitoring Subjects With Fluid-Management Issues In the Home Environment
An observational study of Heart Failure and Hypertension, run by Baxter Healthcare Corporation at 1 site in United States.
Trial summary
This study is designed to validate ease-of-use for the CoVa Monitoring System, along with simple statistical parameters such as reproducibility and inter-subject agreement between test and reference devices. Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Heart Failure, Hypertension
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to May 2014
- Phase
- Observational
- 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 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects will be volunteers from Riverside Meadows Estates. Subjects will be taking one or more diuretic medication(s) prescribed by a physician
Who may be able to join
- Subject is between 21 (twenty-one) and 90 (ninety) years of age at screening.
- Subject will have a current prescription for a diuretic medication.
- Subject and/or legally authorized person/representative is willing to undergo the Informed Consent process prior to enrollment in the study.
- Subject is a candidate for this study based on the PI's opinion and knowledge of the subject's condition.
Who cannot join
- Subject is participating in another clinical study that may affect the results of either study.
- Subject is unable or not willing to wear electrode patches as required.
- Subject has skin sensitivity to adhesive or hydrogel materials used in electrode patches.
- Subject has a pacemaker, implanted cardioverter-defibrillator, or ventricular assist device.
- Subject is considered by the PI to be medically unsuitable for study participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study for Monitoring Subjects With Fluid-Management Issues Using Repeated Measurements In the Home Environment
This study is designed to validate ease-of-use for the CoVa Monitoring System, along with simple statistical parameters such as reproducibility and inter-subject agreement between test and reference devices.
Read the detailed description
The study has the following objectives:
Objective 1: investigate ease-of-use associated with the CoVa Monitoring System: determine if subjects could use the test device on a daily basis, and if the components of this system (Sensor, Gateway, Web-based System) were indeed operational
Objective 2: determine if daily application of the Sensor's adhesive Electrodes resulted in any skin irritation
Objective 3: determine that the long-term reproducibility of measurements made by the test device is as good or better than the long-term reproducibility of the reference device
- Conditions
- Heart Failure, Hypertension
- Keywords
- Heart Failure, Impedance, Fluids
- Medical subject headings
- Heart Failure, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Subjects taking diuretic medication | All subjects will be in the same group, Cohort 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ease of Use
Investigate ease of use associated with the CoVa Monitoring System: determine if subjects could use the test device on a daily basis, and if the components of this system (Sensor, Gateway, Web-based System) were indeed operational
Measured: Each subject will be measured once per weekday over a 6 week period
Secondary outcomes (1)
SKin irritation and reproducibility
Determine if subjects had skin irritation from daily use for 30 days. Determine the long-term reproducibility of the measurements from the test device versus the reference device
Measured: Each subject will be measured once per weekday over a 6 week period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2014 (estimated)
- Study startApr 2014
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baxter Healthcare Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Matthew Banet, PhD, Principal investigator, Baxter Healthcare Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02190877
- Sponsor's protocol ID
- Perm-IRB-001
- Status last verified
- Jul 2014
- First submitted
- 10 Jul 2014
- Last updated
- 23 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study for Monitoring Subjects With Fluid-Management Issues Using Repeated Measurements In the Home Environment
- ClinicalTrials.gov ID
- NCT02190877
- Acronym / sponsor ID
- Perm-IRB-001
- Conditions
- Heart Failure, Hypertension
- Keywords
- Heart Failure, Impedance, Fluids
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Baxter Healthcare CorporationIndustry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 15 Jul 2014 (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.
This study is designed to validate ease-of-use for the CoVa Monitoring System, along with simple statistical parameters such as reproducibility and inter-subject agreement between test and reference devices.
Detailed description
The study has the following objectives:
Objective 1: investigate ease-of-use associated with the CoVa Monitoring System: determine if subjects could use the test device on a daily basis, and if the components of this system (Sensor, Gateway, Web-based System) were indeed operational
Objective 2: determine if daily application of the Sensor's adhesive Electrodes resulted in any skin irritation
Objective 3: determine that the long-term reproducibility of measurements made by the test device is as good or better than the long-term reproducibility of the reference device
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Subjects taking diuretic medication | – | –All subjects will be in the same group, Cohort 1 |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be volunteers from Riverside Meadows Estates. Subjects will be taking one or more diuretic medication(s) prescribed by a physician
Key inclusion criteria (4 listed)
- Subject is between 21 (twenty-one) and 90 (ninety) years of age at screening.
- Subject will have a current prescription for a diuretic medication.
- Subject and/or legally authorized person/representative is willing to undergo the Informed Consent process prior to enrollment in the study.
- Subject is a candidate for this study based on the PI's opinion and knowledge of the subject's condition.
Key exclusion criteria (5 listed)
- Subject is participating in another clinical study that may affect the results of either study.
- Subject is unable or not willing to wear electrode patches as required.
- Subject has skin sensitivity to adhesive or hydrogel materials used in electrode patches.
- Subject has a pacemaker, implanted cardioverter-defibrillator, or ventricular assist device.
- Subject is considered by the PI to be medically unsuitable for study participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ease of Use
Time frame: Each subject will be measured once per weekday over a 6 week period
Investigate ease of use associated with the CoVa Monitoring System: determine if subjects could use the test device on a daily basis, and if the components of this system (Sensor, Gateway, Web-based System) were indeed operational
1 secondary outcome
SKin irritation and reproducibility
Time frame: Each subject will be measured once per weekday over a 6 week period
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 23 Jul 2014.
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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.
Matthew Banet, PhD principal investigator
Baxter Healthcare Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Hypertension, run by Baxter Healthcare Corporation 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: finished, as of the sponsor's last update on 23 Jul 2014. 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?
Ease of Use (time frame: Each subject will be measured once per weekday over a 6 week period). 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 23 Jul 2014.