Heart Rate Variability (HRV) in Pituitary Adenoma

Not Applicable

• Conditions: Pituitary Adenoma
• Interventions: Device: T-REX TRI00A

• Registration Number: NCT03164148
• Lead Sponsor: Seoul St. Mary's Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-05
• Study Start: 2017-05-17
• Study First Submitted: 2017-05-22
• Study First Submitted QC: 2017-05-22
• Last Update Submitted: 2017-05-22
• Study First Posted: 2017-05-23
• Last Update Posted: 2017-05-23
• Primary Completion: 2017-10-16
• Study Completion: 2018-05-16

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Case Evaluation by T-REX TRI00A	T-REX TRI00A	Case evaluation consists of confirmation of hospital visit dates, any side effects of device, T-REX TRI00A

Primary Outcome Measures

Name	Time	Method
Changes in Heart rate variability according to the types of pituitary adenoma	5 month of initial recruit

Trial Locations

Locations (1)

Seoul St. Mary's hospital; 🇰🇷 Seoul, Korea, Republic of