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Heart Rate Variability (HRV) in Pituitary Adenoma

S

Seoul St. Mary's Hospital

Status

Unknown

Conditions

Pituitary Adenoma

Treatments

Device: T-REX TRI00A

Study type

Interventional

Funder types

Other

Identifiers

NCT03164148
KC17OESI0205

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

19+ years old

Volunteers

Accepts 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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

50 participants in 1 patient group

Case Evaluation by T-REX TRI00A
Experimental group
Description:
Case evaluation consists of confirmation of hospital visit dates, any side effects of device, T-REX TRI00A
Treatment:
Device: T-REX TRI00A

Trial contacts and locations

1

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Central trial contact

Jeonghoon Ha, M.D

Data sourced from clinicaltrials.gov

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