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HUTT to Assess Cardiac Autonomic Nervous Function

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ClinicalTrials.gov Identifier: NCT06236945
Recruitment Status : Not yet recruiting
First Posted : February 1, 2024
Last Update Posted : February 1, 2024
Sponsor:
Information provided by (Responsible Party):
Yan Ding, The First Hospital of Hebei Medical University

Tracking Information
First Submitted Date December 27, 2023
First Posted Date February 1, 2024
Last Update Posted Date February 1, 2024
Estimated Study Start Date January 31, 2024
Estimated Primary Completion Date December 31, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 24, 2024)		 To find the indicators which are most correlated to the sympathetic and vagus nerves. [ Time Frame: February 13, 2023 to December 31, 2025 ]
The investigators use HUTT and CASS score to find some indicators which are most correlated to the sympathetic and vagus nerves,so that can give data support to the clinical treatments
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title HUTT to Assess Cardiac Autonomic Nervous Function
Official Title Composite Autonomic Scoring Scale and HUTT to Assess Cardiac Autonomic Nervous Function: A Preliminary Study
Brief Summary Autonomic nervous system diseases can cause abnormalities in the circulatory system, leading to malignant arrhythmia and sudden cardiac death. Standardized, operable, and simplified diagnostic indicators are urgently needed to evaluate autonomic nervous function, particularly cardiac autonomic nervous function. The investigators use HUTT in order to provide data support for cardiac autonomic nervous system evaluation.
Detailed Description In this study, 169 samples with vertical tilt test and 24-h Holter ECG data from February 13, 2023 to October 31, 2023 were selected. The AC, DC, and 24-h HRV were compared with the CASS to identify the indicators with the strongest correlation with the CASS sympathetic and vagus nerve scores. The best index was selected, and the score intervals were delimited. The sensitivity and specificity of the defined vagal and sympathetic intervals were analyzed.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population A total of 169 (74 males, 95 females) samples were collected according to the inclusion and exclusion criteria. Among them, 45 had neurodegenerative diseases caused by SNCA abnormalities, 41 had cerebral arteriosclerosis, 26 had diabetic autonomic neuropathy, and 57 were healthy controls.
Condition Autonomic Nervous System Diseases
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: January 24, 2024)		 169
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2025
Estimated Primary Completion Date December 31, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Vertical tilt test and 24-hour holter electrocardiogram were performed at the same time

    • Receive treatment in our hospital.

Exclusion Criteria:

  • Taking benzodiazepines or hypotensive drugs within 24 hours

    • Combined with mental illness, severe dementia, serious organ disease

      • Severe arrhythmia, deep breathing and poor coordination of Valsaval movements affected the interpretation of results.
Sex/Gender
Sexes Eligible for Study: All
Ages 12 Years to 85 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Yan Ding, M.D. 18633889260 dingding13001300@126.com
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT06236945
Other Study ID Numbers 20230213
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party Yan Ding, The First Hospital of Hebei Medical University
Original Responsible Party Same as current
Current Study Sponsor The First Hospital of Hebei Medical University
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Yan Ding, M.D. Department of Neurology，Xuanwu Hospital，Capital Medical University，Beijing，China.
PRS Account The First Hospital of Hebei Medical University
Verification Date December 2023