Heart Rate Variability (HRV) in Pituitary Adenoma

Pituitary Adenoma Clinical Trial

Official title:

A Study to Observe the Change of the Biological Signal (Heart Rate) During the Combined Pituitary Stimulation Test

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03164148
• Other study ID #: KC17OESI0205
• Status: Recruiting
• Phase: N/A
• First received: May 22, 2017
• Last updated: May 22, 2017
• Start date: May 17, 2017
• Est. completion date: May 16, 2018

Study information

• Verified date: May 2017
• Source: Seoul St. Mary's Hospital
• Contact: Jeonghoon Ha, M.D
• Phone: 82-2-2258-6372
• Email: hajhoon[@]catholic.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 16, 2018
• Est. primary completion date: October 16, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Pituitary Adenoma
• Pituitary Diseases
• Pituitary Neoplasms

Intervention

Device:
• T-REX TRI00A
Case management consists of confirmation of hospital visit date, checking the adverse effect

Locations

Country	Name	City	State
Korea, Republic of	Seoul St. Mary's hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul St. Mary's Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Heart rate variability according to the types of pituitary adenoma		5 month of initial recruit