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Orthostatic HypotensionNCT07309666

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

An observational study of Orthostatic Hypotension, run by Xuanwu Hospital, Beijing at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Orthostatic Hypotension
What is being tested?
Intelligent diagnostic system for orthostatic hypotension
How many people
2,000 participants
Where
1 siteChina
Study dates
1 Mar 2026to 1 Feb 2029
Phase
Observational
Are there results?
Not yet: the study is under way

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 18 years and older
  • All sexes
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site
  • Xuanwu Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100053

Other trials in China

About this study

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.

Read the detailed description

This prospective, multicenter, observational cohort study aims to develop and validate an intelligent diagnostic and risk stratification system for orthostatic hypotension (OH). The study plans to enroll approximately 2000 participants from 15 tertiary clinical centers in China between March 2026 and February 2029. The target population comprises adult patients (≥18 years) with Parkinson's disease (PD) or multiple system atrophy (MSA), and patients aged ≥50 years with diabetes mellitus who are suspected or diagnosed with OH. A key technical inclusion criterion is the presence of adequate bilateral temporal bone windows for reliable transcranial Doppler (TCD) monitoring.

The core methodology involves synchronous, continuous, and non-invasive monitoring of beat-to-beat blood pressure (BP), bilateral cerebral blood flow velocity (CBFv) in the middle cerebral arteries, electrocardiogram (ECG), and end-tidal carbon dioxide (PetCO₂) during a standardized active standing test. Following a 10-minute supine rest, participants rapidly stand and remain upright for up to 10 minutes. Using this integrated data stream, OH is classified as Initial, Classic, or Delayed per consensus hemodynamic thresholds. Dynamic cerebral autoregulation (dCA) is quantitatively assessed offline via transfer function analysis (TFA) of the BP and CBFv signals, deriving phase, gain (absolute and normalized), and coherence parameters in very low frequency (VLF) and low frequency (LF) bands.

Participants are followed for 24 months, with a telephone follow-up at 12 months and an in-person visit at 24 months that includes a repeat stand test and cognitive assessment. The primary technical endpoints are the algorithm-based classification of OH subtype/etiology and the quantitative dCA parameters. Secondary endpoints include the performance (sensitivity, specificity, area under the curve [AUC]) of the derived multimodal risk model in predicting clinical events such as falls, syncope, cognitive decline, and all-cause mortality.

Data analysis will involve machine learning/statistical modeling on a development cohort to generate the risk stratification model, followed by external validation on a separate cohort to assess generalizability and clinical utility.

Being tested
Intelligent diagnostic system for orthostatic hypotension
Keywords
Orthostatic Hypotension, Blood Pressure, Cerebral Blood Flow Velocity, Cerebral Autoregulation, Risk Stratification
Medical subject headings
Hypotension, Orthostatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intelligent diagnostic system for orthostatic hypotensionOther

    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.

Study groups in NCT07309666
Study groupRoleWhat they receive
OH GroupThis 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).
Receives: Other: Intelligent diagnostic system for orthostatic hypotension
Non-OH Control GroupThis 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.
Receives: Other: Intelligent diagnostic system for orthostatic hypotension

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 2years

  2. 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).

    Measured: 2years

Secondary outcomes (2)
  1. Performance of the Risk Stratification Model

    The predictive accuracy of the developed risk stratification model for adverse events (e.g., falls, syncope) will be assessed using metrics including sensitivity, specificity, and the area under the receiver operating characteristic curve (AUC).

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

  2. Incidence of Adverse Clinical Events

    The cumulative incidence of the following clinical events will be recorded and compared between groups: falls, syncope (fainting), fractures, cognitive decline (defined as a decrease in Montreal Cognitive Assessment [MoCA] or Mini-Mental State Examination [MMSE] score from baseline), and all-cause mortality.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Dec 2025
  2. Study start1 Mar 2026 (estimated)
  3. Primary completion1 Aug 2028 (estimated)
  4. Study completion1 Feb 2029 (estimated)

Resources

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
Case-control
Time perspective
Cross-sectional
Enrolment
2,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07309666
Sponsor's protocol ID
AF-SW-01-01.0
Status last verified
Dec 2025
First submitted
15 Dec 2025
Last updated
7 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 35841911
  • 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.

    PubMed 30190008
  • 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.

    PubMed 33752997
  • 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.

    PubMed 28738139
  • 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.

    PubMed 35962478

Questions about this trial

What is this clinical trial studying?

An observational study of Orthostatic Hypotension, run by Xuanwu Hospital, Beijing 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 5 inclusion and 7 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: opening soon, as of the sponsor's last update on 7 Jan 2026. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yingqi Xing (+8618610047846, xingyq2009@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Classification of Orthostatic Hypotension (time frame: 2years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07309666, which also lists 5 linked publications.

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 7 Jan 2026.

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