Heart Rate Variability and Its Association With Symptom of Orthostatic Hypotension in Spinal Cord Injury

Spinal Cord Injuries Clinical Trial

Official title:

Heart Rate Variability and Its Association With Symptom of Orthostatic Hypotension in Spinal Cord Injury

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05982652
• Other study ID #: 05-2021-293
• Status: Active, not recruiting
• Start date: January 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: August 2023
• Source: Pusan National University Yangsan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

In this study, the SCI patients were sub-grouped on the basis of symptoms into symptomatic and asymptomatic groups and measured HRV during resting and tilt up tests to compare their cardiovascular autonomic functions.

Description:

In study protocol and the subjects were asked to lie down quietly for 5 minutes, closing their eyes and avoiding talking, moving hand, legs and body, and coughing during the test. R-R interval and blood pressure were measured beat-to-beat using Finometer® PRO (Finapres Medical Systems, Amsterdam, Netherlands) for 6 minutes each in two positions, supine and 60-degree angle on the tilt table.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• spinal cord injury with or without OH
• aged 19 or older
• ASIA Impairment Scale (AIS) A to D
• neurological level of injury above T6.

Exclusion Criteria:

• Those with heart and respiratory diseases, neurological diseases other than SCI - medically unstable states
• Those who are taking medications affecting BP that cannot be stopped

Related Conditions & MeSH terms

• Heart Rate Variability
• Hypotension
• Hypotension, Orthostatic
• Orthostatic Hypotension
• Spinal Cord Injuries
• Wounds and Injuries

Locations

Country	Name	City	State
Korea, Republic of	Pusan National University Yangsan Hospital, Geumo-ro 20, Mulgeum-eup	Yangsan	Gyeongnam

Sponsors (1)

Lead Sponsor	Collaborator
Pusan National University Yangsan Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Stampas A, Zhu L, Li S. Heart rate variability in spinal cord injury: Asymptomatic orthostatic hypotension is a confounding variable. Neurosci Lett. 2019 Jun 11;703:213-218. doi: 10.1016/j.neulet.2019.03.020. Epub 2019 Mar 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences of heart rate variability between groups (OH vs non-OH, asymptomatic-OH vs symptomatic-OH group)	mean HR (heart rate), mean RR(RR interval), RMSSD (mean square of the successive R-R interval differences), SDNN (standard deviation of normal-to-normal interval), LF (low frequency) domain, HF(High frequency) domain	at the test time (15minutes)
Primary	Logistic regression analysis of heart rate variability variables according to OH and presence of symptom	the investigators conducted logistic regression analysis to evaluate the significance and impact of HRV variables associated with orthostatic hypotension and its symptoms in spinal cord injury patients.	at the test time (15minutes)