Research, Development, and Application of Intelligent Diagnostic System for Orthostatic Hypotension

NCT07309666 | Not Yet Recruiting DMC

• 1 other identifier: AF-SW-01-01.0
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

Orthostatic hypotension (OH) has a high incidence rate of 30%-50% in the elderly and populations with neurodegenerative diseases. The resulting cerebral hypoperfusion significantly increases the risk of cerebral ischemia, falls, and cognitive decline. Traditional OH diagnosis primarily relies on intermittent cuff blood pressure measurements, leading to low detection rates and an inability to provide scientifically effective OH classification. Furthermore, existing research often overlooks cerebral hemodynamic mechanisms, particularly the assessment of dynamic cerebral autoregulation (dCA), making it difficult to study the mechanisms behind OH and its associated symptoms. To address these issues, the research team has preliminarily developed an "Intelligent Diagnostic System for Orthostatic Hypotension". This system innovatively integrates synchronous and continuous monitoring of multiple parameters, including non-invasive beat-to-beat blood pressure, transcranial Doppler (TCD) cerebral blood flow velocity, and electrocardiogram (ECG). It also enables the quantitative assessment of dynamic cerebral autoregulation function. The project will collaborate with fifteen high-level clinical centers in China to collect data from 2000 patients with orthostatic hypotension. The aim is to establish and externally validate a risk stratification model for OH. By integrating multimodal clinical and hemodynamic data, the investigators intend to construct an automated, precise intelligent system for the classification, subtyping, and risk stratification of OH. This initiative will establish a standardized diagnostic and management pathway covering early screening, precise classification, early warning, and stratified intervention. The goal is to provide key technological support for enhancing the early identification and standardized management of OH, thereby reducing its associated disability and mortality rates.

Conditions

Orthostatic Hypotension

Keywords

Orthostatic Hypotension; Blood Pressure; Cerebral Blood Flow Velocity; Cerebral Autoregulation; Risk Stratification

Outcome Measures

Primary Outcomes (2)

• Classification of Orthostatic Hypotension

  Orthostatic hypotension will be subtyped according to the timing of blood pressure reduction after standing: Classical, Initial, or Delayed. Additionally, etiology will be classified as Neurogenic or Non-neurogenic, determined by the heart rate response to blood pressure change, quantified as the ratio of change in heart rate to change in systolic blood pressure (ΔHR/ΔSBP ratio).

  2years

• Dynamic Cerebral Autoregulation Parameters

  Quantitative assessment of dynamic cerebral autoregulation (dCA) function will be performed using Transfer Function Analysis (TFA) on continuous blood pressure and cerebral blood flow velocity signals. Parameters include phase difference, gain, and coherence in the following frequency ranges: very low frequency (VLF: 0.02-0.07 Hz), low frequency (LF: 0.07-0.20 Hz), and high frequency (HF: 0.20-0.70 Hz).

  2years

Secondary Outcomes (2)

• Performance of the Risk Stratification Model

  At the end of the 24-month follow-up period, when outcome data for all participants are available for model validation.

• Incidence of Adverse Clinical Events

  Assessed at 12-month and 24-month follow-up visits.

Study Arms (2)

OH Group

This study enrolls patients diagnosed with orthostatic hypotension (OH). Participants must have one of the following underlying conditions: 1) clinically established or probable Parkinson's disease; 2) clinically diagnosed multiple system atrophy; or 3) diabetes mellitus and aged ≥50 years. All participants in this group must meet the standard diagnostic criteria for OH (a decrease in systolic blood pressure of ≥20 mmHg or a decrease in diastolic blood pressure of ≥10 mmHg within 3 minutes of standing).

Other: Intelligent diagnostic system for orthostatic hypotension

Non-OH Control Group

This study also enrolls a control group of patients without orthostatic hypotension (OH). Control participants must have the same underlying diseases as the OH group (Parkinson's disease, multiple system atrophy, or diabetes mellitus aged ≥50 years) but do not meet the diagnostic criteria for OH during the active standing test. This group is used for comparison with the OH group regarding cerebrovascular hemodynamic parameters and clinical outcomes.

Other: Intelligent diagnostic system for orthostatic hypotension

Interventions

Intelligent diagnostic system for orthostatic hypotension OTHER

All participants will undergo a standardized multi-parameter monitoring protocol. After resting in the supine position for at least 10 minutes, participants will perform an active standing test. During this protocol, the following parameters are continuously and synchronously recorded using the integrated intelligent diagnostic system: non-invasive beat-to-beat blood pressure, cerebral blood flow velocity in the middle cerebral artery (assessed via transcranial Doppler, TCD), electrocardiogram (ECG), and end-tidal carbon dioxide (ETCO₂). Monitoring is conducted for a 10-minute baseline period in the supine position and continues for up to 10 minutes following standing.

Non-OH Control Group; OH Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This prospective, multicenter study aims to enroll approximately 2000 hospitalized adult patients with Parkinson's disease, multiple system atrophy, or diabetes (aged ≥50 for diabetics) who are suspected of having or are diagnosed with orthostatic hypotension (OH). Participants will be recruited from 15 high-level clinical centers in China between March 2026 and February 2029.

You may qualify if:

• Adult patients (≥18 years old).
• Clinical diagnosis of Parkinson's disease (PD) OR multiple system atrophy (MSA) OR diabetes mellitus (if diabetic, must be aged ≥50 years).
• Suspected or diagnosed with orthostatic hypotension (OH).
• Presence of adequate acoustic temporal bone windows for Transcranial Doppler (TCD) monitoring.
• Willing and able to provide informed consent.

You may not qualify if:

• Significant intracranial or extracranial arterial stenosis (≥70% confirmed by ultrasound).
• Recent stroke or intracerebral hemorrhage (confirmed by CT/MRI).
• Severe cardiac arrhythmias (e.g., atrial fibrillation) or severe valvular heart disease.
• Bilateral temporal bone windows insufficient for TCD monitoring.
• Pregnancy or lactation.
• Inability to cooperate with the testing procedures.
• Other systemic diseases that significantly affect cerebral blood flow regulation (e.g., severe thyroid or renal dysfunction).

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead
• The First Hospital of Jilin University: collaborator

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location

Related Publications (5)

• Wieling W, Kaufmann H, Claydon VE, van Wijnen VK, Harms MPM, Juraschek SP, Thijs RD. Diagnosis and treatment of orthostatic hypotension. Lancet Neurol. 2022 Aug;21(8):735-746. doi: 10.1016/S1474-4422(22)00169-7.

  PMID: 35841911 BACKGROUND

• Freeman R, Abuzinadah AR, Gibbons C, Jones P, Miglis MG, Sinn DI. Orthostatic Hypotension: JACC State-of-the-Art Review. J Am Coll Cardiol. 2018 Sep 11;72(11):1294-1309. doi: 10.1016/j.jacc.2018.05.079.

  PMID: 30190008 BACKGROUND

• Thijs RD, Brignole M, Falup-Pecurariu C, Fanciulli A, Freeman R, Guaraldi P, Jordan J, Habek M, Hilz M, Pavy-LeTraon A, Stankovic I, Struhal W, Sutton R, Wenning G, van Dijk JG. Recommendations for tilt table testing and other provocative cardiovascular autonomic tests in conditions that may cause transient loss of consciousness : Consensus statement of the European Federation of Autonomic Societies (EFAS) endorsed by the American Autonomic Society (AAS) and the European Academy of Neurology (EAN). Auton Neurosci. 2021 Jul;233:102792. doi: 10.1016/j.autneu.2021.102792. Epub 2021 Mar 19.

  PMID: 33752997 BACKGROUND

• Juraschek SP, Daya N, Rawlings AM, Appel LJ, Miller ER 3rd, Windham BG, Griswold ME, Heiss G, Selvin E. Association of History of Dizziness and Long-term Adverse Outcomes With Early vs Later Orthostatic Hypotension Assessment Times in Middle-aged Adults. JAMA Intern Med. 2017 Sep 1;177(9):1316-1323. doi: 10.1001/jamainternmed.2017.2937.

  PMID: 28738139 BACKGROUND

• Panerai RB, Brassard P, Burma JS, Castro P, Claassen JA, van Lieshout JJ, Liu J, Lucas SJ, Minhas JS, Mitsis GD, Nogueira RC, Ogoh S, Payne SJ, Rickards CA, Robertson AD, Rodrigues GD, Smirl JD, Simpson DM; Cerebrovascular Research Network (CARNet). Transfer function analysis of dynamic cerebral autoregulation: A CARNet white paper 2022 update. J Cereb Blood Flow Metab. 2023 Jan;43(1):3-25. doi: 10.1177/0271678X221119760. Epub 2022 Aug 12.

  PMID: 35962478 BACKGROUND

MeSH Terms

Conditions

Hypotension, Orthostatic

Condition Hierarchy (Ancestors)

Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Hypotension; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Yingqi Xing

CONTACT

+8618610047846; xingyq2009@sina.com

Yihong Gu

CONTACT

+8618681333508; 947061118@qq.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: December 30, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): February 1, 2029
• Last Updated: January 7, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)