Orthostatic HypotensionCOST3NCT03721393
Data Collection - Of Syncope Tilt Table Testing Study
An observational study of Orthostatic Hypotension and Reflex Syncope, run by Boston Scientific Corporation at 1 site in United States.
Trial summary
To characterize the impact of orthostatic hypotension (OH) and reflex syncope on signals measured using a wearable cardiac monitor prototype device. To evaluate the relationship of signals measured from the wearable cardiac monitor prototype device with reported symptom severity of orthostatic intolerance per standard… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orthostatic Hypotension, Reflex Syncope
- What is being tested?
- Wearable heart monitor
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2019to 8 May 2023
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients that have previously undergone a ARS assessment and were diagnosed with OH or reflex syncope, or are control subjects.
Who may be able to join
- Willing and capable to provide informed consent
- Age 18 or above
- No contraindications to undergo tilt table test, Valsalva maneuver test, and deep breathing test (Components of the ARS assessment)
- Previously underwent a clinically indicated ARS assessment without complications (including deep breathing, Valsalva maneuver, and tilt table testing). Previously diagnosed with OH, reflex syncope, OR control subjects assessed as normal, based on the ARS assessment. Patient enrollment shall be based on the type of diagnosis.
- Willing to participate in one additional tilt table test, Valsalva maneuver test, and deep breathing test (components of the ARS assessment)
Who cannot join
- Currently enrolled in another clinical trial that might interfere with data collection.
- Subject is pregnant or planning to become pregnant during the study
- Active Implantable Medical Device, e.g. cardiac implantable electronic devices, bladder stimulators, diaphragm stimulators, implantable neuro stimulator, implantable active monitoring devices, implantable active drug administration devices, etc.
- Have a prosthetic cardiac valve or previously underwent cardiac valve surgery.
- Known allergy to materials used in the study (adhesive, ECG electrodes)
- Diagnosed with syncope due to cardiologic causes.
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- Have had a myocardial infarction in the previous 90 days
- Have been diagnosed with tachycardia that requires medical treatment
- Experienced complications during previous clinically indicated ARS assessment
- Are on medications that could affect autonomic function, if considered not safe or unwilling to hold such medications for at least four half-lives prior to testing (judged by the study Principal Investigator)
- Have any contraindication for tilt test, Valsalva maneuver test or deep breathing test
Trial locations and contacts
1 site in 1 country.
About this study
To characterize the impact of orthostatic hypotension (OH) and reflex syncope on signals measured using a wearable cardiac monitor prototype device.
To evaluate the relationship of signals measured from the wearable cardiac monitor prototype device with reported symptom severity of orthostatic intolerance per standard data collection, analysis, and questionnaires.
Read the detailed description
This is a non-randomized feasibility study that will enroll up to 50 participants that have undergone a previous autonomic reflect screen (ARS) assessment and were either diagnosed with OH or reflex syncope, or considered to be control subjects for this study.
A maximum of 20 subjects diagnosed with reflex syncope, a maximum of 10 subjects diagnosed with OH and a maximum of 10 control subjects will be enrolled. There will be one study visit per subject.
- Conditions
- Orthostatic Hypotension, Reflex Syncope
- Being tested
- Wearable heart monitor
- Keywords
- tilt table test, valsalva
- Medical subject headings
- Hypotension, Orthostatic, Syncope, Vasovagal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable heart monitorDevice
Participants will be fitted with a wearable heart monitor placed on the skin that measures physiologic signals. There is no intervention or treatment.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Syncope patients | Patients that have undergone an ARS assessment and diagnosed with orthostatic hypotension or reflex syncope. Receives: Device: Wearable heart monitor | |
| Group 2: Control patients | Patients that have undergone an ARS assessment and are control subjects. Receives: Device: Wearable heart monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physiologic Signal Detection
Characterize the impact of orthostatic hypotension (OH) and reflex syncope on physiologic signals measured using a wearable cardiac monitor prototype device.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2018
- Study start4 Oct 2019
- Primary completion8 May 2023
- Study completion8 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthostatic HypotensionStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wolfgang Singer, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03721393
- Sponsor's protocol ID
- C2109
- Acronym
- COST3
- Status last verified
- Aug 2023
- First submitted
- 23 Oct 2018
- Last updated
- 2 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Data Collection - Of Syncope Tilt Table Testing Study
- ClinicalTrials.gov ID
- NCT03721393
- Acronym / sponsor ID
- COST3 / C2109
- Conditions
- Orthostatic Hypotension, Reflex Syncope
- Keywords
- tilt table test, valsalva
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 4 Oct 2019 (actual)
- Primary completion
- 8 May 2023 (actual)
- Study completion
- 8 May 2023 (actual)
- First posted
- 26 Oct 2018 (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.
To characterize the impact of orthostatic hypotension (OH) and reflex syncope on signals measured using a wearable cardiac monitor prototype device.
To evaluate the relationship of signals measured from the wearable cardiac monitor prototype device with reported symptom severity of orthostatic intolerance per standard data collection, analysis, and questionnaires.
Detailed description
This is a non-randomized feasibility study that will enroll up to 50 participants that have undergone a previous autonomic reflect screen (ARS) assessment and were either diagnosed with OH or reflex syncope, or considered to be control subjects for this study.
A maximum of 20 subjects diagnosed with reflex syncope, a maximum of 10 subjects diagnosed with OH and a maximum of 10 control subjects will be enrolled. There will be one study visit per subject.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Syncope patients | – | Device: Wearable heart monitorPatients that have undergone an ARS assessment and diagnosed with orthostatic hypotension or reflex syncope. |
| Group 2: Control patients | – | Device: Wearable heart monitorPatients that have undergone an ARS assessment and are control subjects. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that have previously undergone a ARS assessment and were diagnosed with OH or reflex syncope, or are control subjects.
Key inclusion criteria (5 listed)
- Willing and capable to provide informed consent
- Age 18 or above
- No contraindications to undergo tilt table test, Valsalva maneuver test, and deep breathing test (Components of the ARS assessment)
- Previously underwent a clinically indicated ARS assessment without complications (including deep breathing, Valsalva maneuver, and tilt table testing). Previously diagnosed with OH, reflex syncope, OR control subjects assessed as normal, based on the ARS assessment. Patient enrollment shall be based on the type of diagnosis.
- Willing to participate in one additional tilt table test, Valsalva maneuver test, and deep breathing test (components of the ARS assessment)
Key exclusion criteria (11 listed)
- Currently enrolled in another clinical trial that might interfere with data collection.
- Subject is pregnant or planning to become pregnant during the study
- Active Implantable Medical Device, e.g. cardiac implantable electronic devices, bladder stimulators, diaphragm stimulators, implantable neuro stimulator, implantable active monitoring devices, implantable active drug administration devices, etc.
- Have a prosthetic cardiac valve or previously underwent cardiac valve surgery.
- Known allergy to materials used in the study (adhesive, ECG electrodes)
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 |
|---|---|---|
| Wearable heart monitorParticipants will be fitted with a wearable heart monitor placed on the skin that measures physiologic signals. There is no intervention or treatment. | Device | Group 1: Syncope patients, Group 2: Control patients |
Primary outcome
Physiologic Signal Detection
Time frame: 12 months
Characterize the impact of orthostatic hypotension (OH) and reflex syncope on physiologic signals measured using a wearable cardiac monitor prototype device.
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 2 Aug 2023.
- Individual participant dataSharing planned: No
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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.
Wolfgang Singer, MD principal investigator
Mayo Clinic
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 Orthostatic Hypotension and Reflex Syncope, run by Boston Scientific 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 5 inclusion and 11 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 2 Aug 2023. 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?
Physiologic Signal Detection (time frame: 12 months). 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 2 Aug 2023.