Autonomic Nervous System DiseasesNCT06236945
HUTT to Assess Cardiac Autonomic Nervous Function
An observational study of Autonomic Nervous System Diseases, run by The First Hospital of Hebei Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Autonomic Nervous System Diseases
- How many people
- 1,122 participants
- Where
- 1 siteChina
- Study dates
- 31 Jan 2024to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 85 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: A total of 1122 (546 males, 576 females) samples were collected according to the inclusion and exclusion criteria.
Who may be able to join
- Vertical tilt test and 24-hour holter electrocardiogram were performed at the same time
- Receive treatment in our hospital.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Hospital Of Hebei Medical University
Shijiazhuang, Hebei, 050000
Xuekun Li, Master, 17798061926, xuekunli613@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Autonomic Nervous System Diseases
- Medical subject headings
- Autonomic Nervous System Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
To find the indicators which are most correlated to the sympathetic and vagus nerves.
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
Measured: February 13, 2023 to December 31, 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start31 Jan 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autonomic Nervous System DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Hebei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yan Ding, The First Hospital of Hebei Medical University
- Investigators
- Yan Ding, M.D., Principal investigator, Department of Neurology，Xuanwu Hospital，Capital Medical University，Beijing，China.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06236945
- Sponsor's protocol ID
- 20230213
- Status last verified
- Sep 2024
- First submitted
- 27 Dec 2023
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Composite Autonomic Scoring Scale and HUTT to Assess Cardiac Autonomic Nervous Function: A Preliminary Study
- ClinicalTrials.gov ID
- NCT06236945
- Acronym / sponsor ID
- 20230213
- Conditions
- Autonomic Nervous System Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,122 participants (estimated)
- Lead sponsor
- The First Hospital of Hebei Medical UniversityUniversity, hospital or other
- Study start
- 31 Jan 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 1 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 12 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A total of 1122 (546 males, 576 females) samples were collected according to the inclusion and exclusion criteria.
Key inclusion criteria (2 listed)
- Vertical tilt test and 24-hour holter electrocardiogram were performed at the same time
Key exclusion criteria (3 listed)
- Taking benzodiazepines or hypotensive drugs within 24 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
Related trials for Autonomic Nervous System Diseases
RecruitingPhase 3
Evaluation of IV AMBTX-01 (Neridronate) for Treatment of CRPS Type 1 (CRPS-RISE)
Complex Regional Pain Syndrome Type I
Recruiting
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) in Chronic Kidney Disease (CKD)
Chronic Kidney Diseases
RecruitingEarly Phase 1
[18F]ACI-15916 PET in α-synucleinopathies
Parkinson's Disease (PD), Multiple System Atrophy (MSA)
Active, not recruitingObservational study
Adverse Events During Physical Therapy in Neurocritical ICU Patients
Critical Illness, Brain Injury
Not yet recruitingPhase 2
Aspirin and PAClitaxel in Head & Neck Squamous Cell Carcinoma
Head and Neck (HNSCC), Head and Neck Squamous Cell Carcinoma (HNSCC) - Recurrent/Metastatic (R/M)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yan Ding, M.D. principal investigator
Department of Neurology，Xuanwu Hospital，Capital Medical University，Beijing，China.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autonomic Nervous System Diseases, run by The First Hospital of Hebei Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yan Ding, M.D. (18633889260, dingding13001300@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To find the indicators which are most correlated to the sympathetic and vagus nerves. (time frame: February 13, 2023 to December 31, 2025). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2024.