search
Back to results

Heart Rate Variability (HRV) in Pituitary Adenoma

Primary Purpose

Pituitary Adenoma

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
T-REX TRI00A
Sponsored by
Seoul St. Mary's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pituitary Adenoma

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Seoul St. Mary's hospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Case Evaluation by T-REX TRI00A

Arm Description

Case evaluation consists of confirmation of hospital visit dates, any side effects of device, T-REX TRI00A

Outcomes

Primary Outcome Measures

Changes in Heart rate variability according to the types of pituitary adenoma

Secondary Outcome Measures

Full Information

First Posted
May 22, 2017
Last Updated
May 22, 2017
Sponsor
Seoul St. Mary's Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03164148
Brief Title
Heart Rate Variability (HRV) in Pituitary Adenoma
Official Title
A Study to Observe the Change of the Biological Signal (Heart Rate) During the Combined Pituitary Stimulation Test
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 17, 2017 (Actual)
Primary Completion Date
October 16, 2017 (Anticipated)
Study Completion Date
May 16, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul St. Mary's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pituitary Adenoma

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Case Evaluation by T-REX TRI00A
Arm Type
Experimental
Arm Description
Case evaluation consists of confirmation of hospital visit dates, any side effects of device, T-REX TRI00A
Intervention Type
Device
Intervention Name(s)
T-REX TRI00A
Intervention Description
Case management consists of confirmation of hospital visit date, checking the adverse effect
Primary Outcome Measure Information:
Title
Changes in Heart rate variability according to the types of pituitary adenoma
Time Frame
5 month of initial recruit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeonghoon Ha, M.D
Phone
82-2-2258-6372
Email
hajhoon@catholic.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
DongJun Lim, M.D, PhD.
Organizational Affiliation
Seoul St. Mary's Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Seoul St. Mary's hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeonghoon Ha, M.D
Phone
82-2-2258-6372
Email
hajhoon@catholic.ac.kr

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Heart Rate Variability (HRV) in Pituitary Adenoma

We'll reach out to this number within 24 hrs