Heart Rate Variability (HRV) in Pituitary Adenoma

May 22, 2017 updated by: Dong Jun Lim, Seoul St. Mary's Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 06591
        • Recruiting
        • Seoul St. Mary's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Case Evaluation by T-REX TRI00A
Case evaluation consists of confirmation of hospital visit dates, any side effects of device, T-REX TRI00A
Device: T-REX TRI00A
Case management consists of confirmation of hospital visit date, checking the adverse effect

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in Heart rate variability according to the types of pituitary adenoma
Time Frame: 5 month of initial recruit
5 month of initial recruit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul St. Mary's Hospital

Investigators

  • Study Chair: DongJun Lim, M.D, PhD., Seoul St. Mary's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 17, 2017

Primary Completion (Anticipated)

October 16, 2017

Study Completion (Anticipated)

May 16, 2018

Study Registration Dates

First Submitted

May 22, 2017

First Submitted That Met QC Criteria

May 22, 2017

First Posted (Actual)

May 23, 2017

Study Record Updates

Last Update Posted (Actual)

May 23, 2017

Last Update Submitted That Met QC Criteria

May 22, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KC17OESI0205

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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