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Research, Development, and Application of Intelligent Diagnostic System for Orthostatic Hypotension 2,000 Non-Invasive Senior-Focused
Clinical Trial NCT07309666 is an observational study for Orthostatic Hypotension and is currently not yet recruiting. Enrollment is planned to begin on 1 March 2026 and continue until the study accrues 2,000 participants. Led by Xuanwu Hospital, Beijing, this study is expected to complete by 1 February 2029. The latest data from ClinicalTrials.gov was last updated on 7 January 2026.
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 ef...Show More
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 sy...Show More
Official Title
Research, Development, and Application of Intelligent Diagnostic System for Orthostatic Hypotension
Conditions
Orthostatic HypotensionPublications
Scientific articles and research papers published about this clinical trial:Other Study IDs
- AF-SW-01-01.0
NCT ID Number
Start Date (Actual)
2026-03-01
Last Update Posted
2026-01-07
Completion Date (Estimated)
2029-02-01
Enrollment (Estimated)
2,000
Study Type
Observational
Status
Not yet recruiting
Keywords
Orthostatic Hypotension
Blood Pressure
Cerebral Blood Flow Velocity
Cerebral Autoregulation
Risk Stratification
Blood Pressure
Cerebral Blood Flow Velocity
Cerebral Autoregulation
Risk Stratification
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
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 m...Show More | Intelligent diagnostic system for orthostatic hypotension 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 midd...Show More |
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 ...Show More | Intelligent diagnostic system for orthostatic hypotension 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 midd...Show More |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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). | 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 | 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. | Assessed at 12-month and 24-month follow-up visits. |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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.
- 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).
Xuanwu Hospital, BeijingThe First Hospital of Jilin UniversityStudy Central Contact
Contact: Yingqi Xing, +8618610047846, [email protected]
Contact: Yihong Gu, +8618681333508, [email protected]
1 Study Locations in 1 Countries
Beijing Municipality
Xuanwu Hospital, Capital Medical University, Beijing, Beijing Municipality, 100053, China