Heart Rate Variability (HRV) in Pituitary Adenoma
A Study to Observe the Change of the Biological Signal (Heart Rate) During the Combined Pituitary Stimulation Test
1 other identifier
interventional
50
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 17, 2017
CompletedFirst Submitted
Initial submission to the registry
May 22, 2017
CompletedFirst Posted
Study publicly available on registry
May 23, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 16, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 16, 2018
CompletedMay 23, 2017
May 1, 2017
5 months
May 22, 2017
May 22, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Changes in Heart rate variability according to the types of pituitary adenoma
5 month of initial recruit
Study Arms (1)
Case Evaluation by T-REX TRI00A
EXPERIMENTALCase evaluation consists of confirmation of hospital visit dates, any side effects of device, T-REX TRI00A
Interventions
Case management consists of confirmation of hospital visit date, checking the adverse effect
Eligibility Criteria
You may qualify if:
- Over 19 year old
- Those with Normal blood pressure range:
- mmHg \<systolic \<140mmHg, 60mmHg \<diastolic \<100mmHg
- Voluntary participants who visited Seoul St. Mary's Hospital
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul St. Mary's hospital
Seoul, 06591, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
DongJun Lim, M.D, PhD.
Seoul St. Mary's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 22, 2017
First Posted
May 23, 2017
Study Start
May 17, 2017
Primary Completion
October 16, 2017
Study Completion
May 16, 2018
Last Updated
May 23, 2017
Record last verified: 2017-05