Pituitary AdenomaNCT03164148
Heart Rate Variability (HRV) in Pituitary Adenoma
A study testing T-REX TRI00A in people with Pituitary Adenoma, run by Seoul St. Mary's Hospital at 1 site in South Korea.
Trial summary
Several studies have been reported that heart rate is known to be associated with prognosis in chronic diseases and acute diseases. For example, a decrease in heart rate following myocardial infarction may lead to a higher mortality rate. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pituitary Adenoma
- What is being tested?
- T-REX TRI00A
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 May 2017to 16 May 2018
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Over 19 year old
- Those with Normal blood pressure range:
- 90mmHg <systolic <140mmHg, 60mmHg <diastolic <100mmHg
- Voluntary participants who visited Seoul St. Mary's Hospital
Who cannot join
- Those who have been diagnosed with sleep disorders, diabetes, arrhythmia, psychiatric disorder, physical or mental breakdown, drug addicts
- Diabetes, hypertension, cardiovascular disease diagnosed by taking a drug related to the disease
- Pregnant or lactating women
- Those who drank within 12 hours before participating in the trial
- Those who are deemed inappropriate by clinical trial researchers
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul St. Mary's hospital
Seoul, 06591
Jeonghoon Ha, M.D, 82-2-2258-6372, hajhoon@catholic.ac.kr
About this study
Official title: A Study to Observe the Change of the Biological Signal (Heart Rate) During the Combined Pituitary Stimulation Test
Several studies have been reported that heart rate is known to be associated with prognosis in chronic diseases and acute diseases. For example, a decrease in heart rate following myocardial infarction may lead to a higher mortality rate. It is also known to predict heart failure, diabetic neuropathy, and even depression.
The combined pituitary function test artificially induces hypoglycemia to observe the secretion of pituitary hormone. The degree of change in heart rate during hypoglycemia can predict the adequacy of the test, and heart rate can be changed according to the characteristic of the tumor. Also, the prognosis can be predicted based on this.
In our study, we used a licensed device approved by KFDA (Korea Food and Drug Administration) to measure heart rate variability in patients with pituitary adenoma.
- Conditions
- Pituitary Adenoma
- Being tested
- T-REX TRI00A
- Medical subject headings
- Pituitary Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T-REX TRI00ADevice
Case management consists of confirmation of hospital visit date, checking the adverse effect
| Study group | Role | What they receive |
|---|---|---|
| Case Evaluation by T-REX TRI00A | Experimental | Case evaluation consists of confirmation of hospital visit dates, any side effects of device, T-REX TRI00A Receives: Device: T-REX TRI00A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Heart rate variability according to the types of pituitary adenoma
Measured: 5 month of initial recruit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2017
- Study start17 May 2017
- Primary completion16 Oct 2017 (estimated)
- Study completion16 May 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pituitary AdenomaStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul St. Mary's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong Jun Lim, Seoul St. Mary's Hospital
- Investigators
- DongJun Lim, M.D, PhD., Study chair, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03164148
- Sponsor's protocol ID
- KC17OESI0205
- Status last verified
- May 2017
- First submitted
- 22 May 2017
- Last updated
- 23 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Observe the Change of the Biological Signal (Heart Rate) During the Combined Pituitary Stimulation Test
- ClinicalTrials.gov ID
- NCT03164148
- Acronym / sponsor ID
- KC17OESI0205
- Conditions
- Pituitary Adenoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Seoul St. Mary's HospitalUniversity, hospital or other
- Study start
- 17 May 2017 (actual)
- Primary completion
- 16 Oct 2017 (estimated)
- Study completion
- 16 May 2018 (estimated)
- First posted
- 23 May 2017 (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.
Several studies have been reported that heart rate is known to be associated with prognosis in chronic diseases and acute diseases. For example, a decrease in heart rate following myocardial infarction may lead to a higher mortality rate. It is also known to predict heart failure, diabetic neuropathy, and even depression.
The combined pituitary function test artificially induces hypoglycemia to observe the secretion of pituitary hormone. The degree of change in heart rate during hypoglycemia can predict the adequacy of the test, and heart rate can be changed according to the characteristic of the tumor. Also, the prognosis can be predicted based on this.
In our study, we used a licensed device approved by KFDA (Korea Food and Drug Administration) to measure heart rate variability in patients with pituitary adenoma.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Case Evaluation by T-REX TRI00A | Experimental | Device: T-REX TRI00ACase evaluation consists of confirmation of hospital visit dates, any side effects of device, T-REX TRI00A |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Over 19 year old
- Those with Normal blood pressure range:
- 90mmHg <systolic <140mmHg, 60mmHg <diastolic <100mmHg
- Voluntary participants who visited Seoul St. Mary's Hospital
Key exclusion criteria (5 listed)
- Those who have been diagnosed with sleep disorders, diabetes, arrhythmia, psychiatric disorder, physical or mental breakdown, drug addicts
- Diabetes, hypertension, cardiovascular disease diagnosed by taking a drug related to the disease
- Pregnant or lactating women
- Those who drank within 12 hours before participating in the trial
- Those who are deemed inappropriate by clinical trial researchers
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 |
|---|---|---|
| T-REX TRI00ACase management consists of confirmation of hospital visit date, checking the adverse effect | Device | Case Evaluation by T-REX TRI00A |
Primary outcome
Changes in Heart rate variability according to the types of pituitary adenoma
Time frame: 5 month of initial recruit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2017.
- 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.
DongJun Lim, M.D, PhD. study chair
Seoul St. Mary's 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 T-REX TRI00A in people with Pituitary Adenoma, run by Seoul St. Mary's Hospital at 1 site in South Korea.
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 23 May 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 South Korea. 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 Jeonghoon Ha, M.D (82-2-2258-6372, hajhoon@catholic.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Heart rate variability according to the types of pituitary adenoma (time frame: 5 month of initial recruit). 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 May 2017.