Heart Rate Variability (HRV) in Pituitary Adenoma | NCT03164148

Studies
Heart Rate Variability (HRV) in Pituitary Adenoma

NCT03164148

Sponsor

Seoul St. Mary's Hospital

Status

Unknown status

Last Update Posted

May 23, 2017Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Pituitary Adenoma

Interventions

T-REX TRI00A

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 17, 2017Actual

Primary Completion Date

Oct 16, 2017Estimated

Completion Date

May 16, 2018Estimated

First Submitted Date

May 22, 2017

First Submission Date that Met QC Criteria

May 22, 2017

First Posted Date

May 23, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 22, 2017

Last Update Posted Date

May 23, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Case Evaluation by T-REX TRI00A	Experimental	Case evaluation consists of confirmation of hospital visit dates, any side effects of device, T-REX TRI00A	Device: T-REX TRI00A

Interventions

Name	Type	Description	Arm Group Labels	Other Names
T-REX TRI00A	Device	Case management consists of confirmation of hospital visit date, checking the adverse effect	Case Evaluation by T-REX TRI00A

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Over 19 year old
Those with Normal blood pressure range:

90mmHg \

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jeonghoon Ha, M.D	Contact	82-2-2258-6372		hajhoon@catholic.ac.kr

Overall Officials

Name	Affiliation	Role
DongJun Lim, M.D, PhD.	Seoul St. Mary's Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul St. Mary's hospital	Recruiting	Seoul		06591	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010911	Pituitary Neoplasms

Ancestor Terms

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D007029	Hypothalamic Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided