HealthyCardioSanNCT05706532
Cardiovascular and Cerebrovascular Control in Healthy Subjects
An observational study of Healthy and Autonomic Nervous System, run by IRCCS Policlinico S. Donato at 1 site in Italy.
Trial summary
The aim of the study is to evaluate autonomic function and cerebrovascular control in 60 healthy subjects by means of noninvasive analysis of time series variability. To this extent, heart period, systolic and mean arterial blood pressure, cerebral blood velocity, peripheral resistances, respiration will be recorded… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy, Autonomic Nervous System, Cerebral Autoregulation
- What is being tested?
- active standing
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 29 May 2023to Oct 2027
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy subjects
Who may be able to join
- age >18
- sinus rhythm
- informed consent signed
Who cannot join
- age <18
- presence of autonomic nervous system diseases or dysfunctions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Policlinico San Donato
San Donato Milanese, Milan, 20097
Vlasta Bari, PhD, +390252774381, vlasta.bari@grupposandonato.it
Marco Ranucci, MD
About this study
Official title: Cardiovascular and Cerebrovascular Control in Healthy Adult Subjects
The aim of the study is to evaluate autonomic function and cerebrovascular control in 60 healthy subjects by means of noninvasive analysis of time series variability.
To this extent, heart period, systolic and mean arterial blood pressure, cerebral blood velocity, peripheral resistances, respiration will be recorded from subjects during an orthostatic challenge.
The interactions between autonomic cardiovascular function, cerebrovascular and peripheral control will be evaluated exploiting the most advanced signal processing techniques.
- Conditions
- Healthy, Autonomic Nervous System, Cerebral Autoregulation
- Being tested
- active standing
- Keywords
- autonomic nervous system, heart rate variability, cerebral autoregulation, peripheral resistances
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active standingDiagnostic test
Data are acquired with patients resting in supine position for 10 minutes and for 10 minutes during active standing
| Study group | Role | What they receive |
|---|---|---|
| Healthy | 60 healthy subjects; age >18; sinus rhythm; absence of autonomic diseases or dysfunctions. Receives: Diagnostic Test: active standing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the state and interactions of autonomic function and cerebrovascular control
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start29 May 2023
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by IRCCS Policlinico S. DonatoThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Policlinico S. Donato
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vlasta Bari, IRCCS Policlinico S. Donato
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05706532
- Sponsor's protocol ID
- CardioSan
- Acronym
- CardioSan
- Status last verified
- Jul 2026
- First submitted
- 23 Jan 2023
- Last updated
- 6 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular and Cerebrovascular Control in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT05706532
- Acronym / sponsor ID
- CardioSan / CardioSan
- Conditions
- Healthy, Autonomic Nervous System, Cerebral Autoregulation
- Keywords
- autonomic nervous system, heart rate variability, cerebral autoregulation, peripheral resistances
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- IRCCS Policlinico S. DonatoUniversity, hospital or other
- Study start
- 29 May 2023 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 31 Jan 2023 (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.
The aim of the study is to evaluate autonomic function and cerebrovascular control in 60 healthy subjects by means of noninvasive analysis of time series variability.
To this extent, heart period, systolic and mean arterial blood pressure, cerebral blood velocity, peripheral resistances, respiration will be recorded from subjects during an orthostatic challenge.
The interactions between autonomic cardiovascular function, cerebrovascular and peripheral control will be evaluated exploiting the most advanced signal processing techniques.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy | – | Diagnostic Test: active standing60 healthy subjects; age >18; sinus rhythm; absence of autonomic diseases or dysfunctions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy subjects
Key inclusion criteria (3 listed)
- age >18
- sinus rhythm
- informed consent signed
Key exclusion criteria (2 listed)
- age <18
- presence of autonomic nervous system diseases or dysfunctions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| active standingData are acquired with patients resting in supine position for 10 minutes and for 10 minutes during active standing | Diagnostic test | Healthy |
Primary outcome
Evaluate the state and interactions of autonomic function and cerebrovascular control
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: No
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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.
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 Healthy and Autonomic Nervous System, run by IRCCS Policlinico S. Donato at 1 site in Italy.
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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 6 Jul 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 Italy. 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 Vlasta Bari, PhD (+390252774381, vlasta.bari@grupposandonato.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the state and interactions of autonomic function and cerebrovascular control (time frame: 12 months). 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 6 Jul 2026.