Heart FailureNCT05646056
A Noninterventional, Single-Center Feasibility Study to Evaluate Measures of Heart Failure Risk
An observational study of Heart Failure and Cardiomyopathy, Hypertrophic, run by Prolaio at 1 site in United States.
Trial summary
This is a non-invasive/observational study in healthy and mild HF subjects utilizing clinical and ambulatory measurements to improve detection, monitoring, and management of HF risks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Cardiomyopathy, Hypertrophic, Left Ventricular Hypertrophy
- What is being tested?
- Software
- Type of treatment
- Medical device
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2022to 18 Sep 2024
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Single-center study of asymptomatic healthy subjects and subjects with HF risk factors and no more than mild to moderate symptoms
Who may be able to join
- Cohort 2: Confirmed medical history of LVH based on American College of Cardiology (ACC)/American Heart Association (AHA) guidelines and NYHA Class I at screening
- Cohort 3: Confirmed medical history of HF consistent with current ACC/AHA guidelines and NYHA Class I at screening
- Cohort 4: Confirmed medical history of HCM consistent with ACC/AHA guidelines and NYHA Class I or II at screening
Who cannot join
- Active neurological disorder, such as uncontrolled seizure disorder.
- Current diagnosis of cancer or other known acute chronic infection, such as hepatitis B or hepatitis C, by medical history or an active infection requiring interventional therapy at screening.
- Shortness of breath, fatigue, heart palpitations, pain, or other limitations of physical activity
Trial locations and contacts
1 site in 1 country.
United States1 site
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
About this study
Official title: A Noninterventional, Single-Center Feasibility Study to Evaluate Longitudinal Measures of Heart Failure Risk Using the Pyxida System
This is a non-invasive/observational study in healthy and mild HF subjects utilizing clinical and ambulatory measurements to improve detection, monitoring, and management of HF risks.
- Being tested
- Software
- Medical subject headings
- Heart Failure, Cardiomyopathy, Hypertrophic, Hypertrophy, Left Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SoftwareDevice
Observation only
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | Not described Receives: Device: Software | |
| Asymptomatic subjects with a history of left ventricular hypertrophy (LVH) and NYHA Class I | Not described Receives: Device: Software | |
| Asymptomatic subjects with a history of heart failure (HF) and NYHA Class I | Not described Receives: Device: Software | |
| Subjects with a history of hypertrophic cardiomyopathy (HCM) and NYHA Class I, II | Not described Receives: Device: Software |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the ability of the Pyxida System to collect measurements of heart failure (HF) risk
Percentage of complete daily datasets transmitted to the Pyxida System database at the end of the monitoring period
Measured: 14 days
Secondary outcomes (1)
To evaluate subject compliance and experience using the Pyxida System
Outcomes of subject post-study survey
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start28 Oct 2022
- Primary completion18 Sep 2024
- Study completion18 Sep 2024
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
- Prospective
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prolaio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Koren, MD, Principal investigator, Jacksonville Center For Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05646056
- Sponsor's protocol ID
- PRO-001-001
- Status last verified
- Oct 2024
- First submitted
- 23 Nov 2022
- Last updated
- 24 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Noninterventional, Single-Center Feasibility Study to Evaluate Longitudinal Measures of Heart Failure Risk Using the Pyxida System
- ClinicalTrials.gov ID
- NCT05646056
- Acronym / sponsor ID
- PRO-001-001
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- ProlaioIndustry (pharma, biotech, devices)
- Study start
- 28 Oct 2022 (actual)
- Primary completion
- 18 Sep 2024 (actual)
- Study completion
- 18 Sep 2024 (actual)
- First posted
- 12 Dec 2022 (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.
This is a non-invasive/observational study in healthy and mild HF subjects utilizing clinical and ambulatory measurements to improve detection, monitoring, and management of HF risks.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | – | Device: Software |
| Asymptomatic subjects with a history of left ventricular hypertrophy (LVH) and NYHA Class I | – | Device: Software |
| Asymptomatic subjects with a history of heart failure (HF) and NYHA Class I | – | Device: Software |
| Subjects with a history of hypertrophic cardiomyopathy (HCM) and NYHA Class I, II | – | Device: Software |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Single-center study of asymptomatic healthy subjects and subjects with HF risk factors and no more than mild to moderate symptoms
Key inclusion criteria (3 listed)
- Cohort 2: Confirmed medical history of LVH based on American College of Cardiology (ACC)/American Heart Association (AHA) guidelines and NYHA Class I at screening
- Cohort 3: Confirmed medical history of HF consistent with current ACC/AHA guidelines and NYHA Class I at screening
- Cohort 4: Confirmed medical history of HCM consistent with ACC/AHA guidelines and NYHA Class I or II at screening
Key exclusion criteria (3 listed)
- Active neurological disorder, such as uncontrolled seizure disorder.
- Current diagnosis of cancer or other known acute chronic infection, such as hepatitis B or hepatitis C, by medical history or an active infection requiring interventional therapy at screening.
- Shortness of breath, fatigue, heart palpitations, pain, or other limitations of physical activity
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 |
|---|---|---|
| SoftwareObservation only | Device | Asymptomatic subjects with a history of heart failure (HF) and NYHA Class I, Asymptomatic subjects with a history of left ventricular hypertrophy (LVH) and NYHA Class I, Healthy subjects, Subjects with a history of hypertrophic cardiomyopathy (HCM) and NYHA Class I, II |
Primary outcome
To evaluate the ability of the Pyxida System to collect measurements of heart failure (HF) risk
Time frame: 14 days
Percentage of complete daily datasets transmitted to the Pyxida System database at the end of the monitoring period
1 secondary outcome
To evaluate subject compliance and experience using the Pyxida System
Time frame: 14 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 24 Oct 2024.
- Individual participant dataSharing planned: Undecided
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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.
Michael Koren, MD principal investigator
Jacksonville Center For Clinical Research
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 Cardiomyopathy, Hypertrophic, run by Prolaio 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 3 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 24 Oct 2024. 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?
To evaluate the ability of the Pyxida System to collect measurements of heart failure (HF) risk (time frame: 14 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 24 Oct 2024.