HUTT to Assess Cardiac Autonomic Nervous Function

January 24, 2024 updated by: Yan Ding, The First Hospital of Hebei Medical University

Composite Autonomic Scoring Scale and HUTT to Assess Cardiac Autonomic Nervous Function: A Preliminary Study

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.

Study Overview

Status

Not yet recruiting

Conditions

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

Enrollment (Estimated)

169

Contacts and Locations

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

Study Contact

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
February 13, 2023 to December 31, 2025

Collaborators and Investigators

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

Sponsor

The First Hospital of Hebei Medical University

Investigators

  • Principal Investigator: Yan Ding, M.D., Department of Neurology，Xuanwu Hospital，Capital Medical University，Beijing，China.

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 (Estimated)

January 31, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

December 27, 2023

First Submitted That Met QC Criteria

January 24, 2024

First Posted (Estimated)

February 1, 2024

Study Record Updates

Last Update Posted (Estimated)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 24, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20230213

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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