Autonomic DysfunctionNCT05977335
Continuous and Non-invasive Measurements by Task Force® CORE/CARDIO in Autonomic Function Testing (AFT)
An observational study of Autonomic Dysfunction and Orthostatic Intolerance, run by CNSystems Medizintechnik GmbH.
Trial summary
Background: The investigational device, "Task Force® CORE" (TFC, CNSystems Medizintechnik GmbH, Graz, Austria) together with the "Task Force® CARDIO" (TFCARDIO, CNSystems Medizintechnik GmbH, Graz, Austria) medical device software, is a new CE-marked medical device for continuous non-invasive determination of blood… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autonomic Dysfunction, Orthostatic Intolerance
- What is being tested?
- Autonomic Function Testing
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 1 Dec 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients who present at the Referral Center for Autonomic Nervous System of the University Hospital Center Zagreb referred to autonomous nervous system testing will be included.
Who may be able to join
- Adult patients (patients aged ≥ 18 years)
- Patients giving written informed consent to participate in the study.
- Patients with intact perfusion of both hands evidenced by a positive Allen's test.
- Patients with orthostatic intolerance will be included
Who cannot join
- Patients with vascular implants at the sites of non-invasive BP measurement (fingers or upper arms)
- Very low perfusion in the periphery
- Arterial vascular diseases (arteriosclerosis, Raynaud's syndrome, endarteritis obliterans, collagenosis, severely advanced vascular diseases (PAOD))
- Patients with significant edema in the fingers
- Patients with atrial fibrillation
- Patients with valvular disease of grade 2 or above
Show all 9Show fewer
- Patients with ventricular assist devices
- Subjects not passing the Allen's test for both hands.
- Patients with a large lateral difference in BP (> 15 mmHg for systolic BP and/or >10 mmHg for diastolic BP) or with same arm measurement differences > 10 mmHg in systolic or diastolic BP during assessment of lateral differences
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Background: The investigational device, "Task Force® CORE" (TFC, CNSystems Medizintechnik GmbH, Graz, Austria) together with the "Task Force® CARDIO" (TFCARDIO, CNSystems Medizintechnik GmbH, Graz, Austria) medical device software, is a new CE-marked medical device for continuous non-invasive determination of blood pressure (BP), cardiac output (CO) and derived parameters based on the well established CNAP® (continuous non-invasive arterial pressure) technology by CNSystems.
Aim: The primary aim of this prospective, method comparison, open study is data acquisition for the performance evaluation of the TFC during autonomic function testing in comparison with an clinically accepted reference method. Setting: The setting of the clinical investigation will be the autonomic function testing laboratory at the Department of Neurology, the University Hospital Center Zagreb.
Read more
Inclusion criteria: Patients who are over 18 years and who provide written informed consent.
Sample size: The study has an calculated sample size of 70 patients. Considering a drop-out rate of 5%, a total of 75 patients will be included.
Statistics: Descriptive statistics, values for the percentage error and correlation estimates will be derived. Furthermore, scatterplot, Bland-Altman analysis, concordance analysis of parameter changes and further comparative statistics will be performed.
- Conditions
- Autonomic Dysfunction, Orthostatic Intolerance
- Being tested
- Autonomic Function Testing
- Keywords
- Blood Pressure, Hemodynamics, Non-invasive, Continuous, Autonomic Function Testing
- Medical subject headings
- Primary Dysautonomias, Orthostatic Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autonomic Function TestingDiagnostic test
Autonomic Function Testing (AFT) includes Valsalva Manoever, Deep Breathing Test, and Head-up Tilt Table Testing.
| Study group | Role | What they receive |
|---|---|---|
| Orthostatic Intolerance Patients | Not described Receives: Diagnostic Test: Autonomic Function Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement of blood pressure between investigational and reference device.
The agreement of blood pressure variables [systolic, diastolic and mean pressure in mmHg [millimetres of mercury)] between both devices will be assessed by means of Scatterplot and Bland-Altman analysis.
Measured: The agreement is calculated for the 5 minutes supine baseline period
Agreement of blood pressure between investigational and reference device.
The agreement of blood pressure variables [systolic, diastolic and mean pressure in mmHg [millimetres of mercury)] between both devices will be assessed by means of Scatterplot and Bland-Altman analysis.
Measured: The agreement is calculated for 60 seconds: during (15 seconds) plus after (45 seconds) valsava maneuver
Agreement of blood pressure between investigational and reference device.
The agreement of blood pressure variables [systolic, diastolic and mean pressure in mmHg [millimetres of mercury)] between both devices will be assessed by means of Scatterplot and Bland-Altman analysis.
Measured: The agreement is calculated for 90 seconds Deep Breathing period
Agreement of blood pressure between investigational and reference device.
The agreement of blood pressure variables [systolic, diastolic and mean pressure in mmHg [millimetres of mercury)] between both devices will be assessed by means of Scatterplot and Bland-Altman analysis.
Measured: The agreement is calculated for 10 minutes head-up tilt table test period
Agreement of heart rate between investigational and reference device.
The agreement of heart rate (bpm [beats per minute)] between both devices will be assessed by means of Scatterplot and Bland-Altman analysis.
Measured: The agreement is calculated for the 5 minutes supine baseline period
Agreement of heart rate between investigational and reference device.
The agreement of heart rate (bpm [beats per minute)] between both devices will be assessed by means of Scatterplot and Bland-Altman analysis.
Measured: The agreement is calculated for 60 seconds: during (15 seconds) plus after (45 seconds) valsava maneuver
Agreement of heart rate between investigational and reference device.
The agreement of heart rate (bpm [beats per minute)] between both devices will be assessed by means of Scatterplot and Bland-Altman analysis.
Measured: The agreement is calculated for 90 seconds Deep Breathing period
Agreement of heart rate between investigational and reference device.
The agreement of heart rate (bpm [beats per minute)] between both devices will be assessed by means of Scatterplot and Bland-Altman analysis.
Measured: The agreement is calculated for 10 minutes head-up tilt table test period
Agreement of cardiac output between investigational and reference device.
The agreement of cardiac output (in l/min) between both devices will be assessed by means of Scatterplot and Bland-Altman analysis.
Measured: The agreement is calculated for the 5 minutes supine baseline period
Agreement of cardiac output between investigational and reference device.
The agreement of cardiac output (in l/min) between both devices will be assessed by means of Scatterplot and Bland-Altman analysis.
Measured: The agreement is calculated for 60 seconds: during (15 seconds) plus after (45 seconds) valsava maneuver
Agreement of cardiac output between investigational and reference device.
The agreement of cardiac output (in l/min) between both devices will be assessed by means of Scatterplot and Bland-Altman analysis.
Measured: The agreement is calculated for 90 seconds Deep Breathing period
Agreement of cardiac output between investigational and reference device.
The agreement of cardiac output (in l/min) between both devices will be assessed by means of Scatterplot and Bland-Altman analysis.
Measured: The agreement is calculated for 10 minutes head-up tilt table test period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start1 Nov 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autonomic DysfunctionStudies 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
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CNSystems Medizintechnik GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05977335
- Sponsor's protocol ID
- AFTs Task Force® CORE/CARD
- Status last verified
- Mar 2026
- First submitted
- 18 Jul 2023
- Last updated
- 18 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous and Non-invasive Measurements by Task Force® CORE/CARDIO in Autonomic Function Testing (AFT)
- ClinicalTrials.gov ID
- NCT05977335
- Acronym / sponsor ID
- AFTs Task Force® CORE/CARD
- Conditions
- Autonomic Dysfunction, Orthostatic Intolerance
- Keywords
- Blood Pressure, Hemodynamics, Non-invasive, Continuous, Autonomic Function Testing
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- CNSystems Medizintechnik GmbHIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 4 Aug 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.
Background: The investigational device, "Task Force® CORE" (TFC, CNSystems Medizintechnik GmbH, Graz, Austria) together with the "Task Force® CARDIO" (TFCARDIO, CNSystems Medizintechnik GmbH, Graz, Austria) medical device software, is a new CE-marked medical device for continuous non-invasive determination of blood pressure (BP), cardiac output (CO) and derived parameters based on the well established CNAP® (continuous non-invasive arterial pressure) technology by CNSystems.
Aim: The primary aim of this prospective, method comparison, open study is data acquisition for the performance evaluation of the TFC during autonomic function testing in comparison with an clinically accepted reference method. Setting: The setting of the clinical investigation will be the autonomic function testing laboratory at the Department of Neurology, the University Hospital Center Zagreb.
Inclusion criteria: Patients who are over 18 years and who provide written informed consent.
Sample size: The study has an calculated sample size of 70 patients. Considering a drop-out rate of 5%, a total of 75 patients will be included.
Statistics: Descriptive statistics, values for the percentage error and correlation estimates will be derived. Furthermore, scatterplot, Bland-Altman analysis, concordance analysis of parameter changes and further comparative statistics will be performed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Orthostatic Intolerance Patients | – | Diagnostic Test: Autonomic Function Testing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who present at the Referral Center for Autonomic Nervous System of the University Hospital Center Zagreb referred to autonomous nervous system testing will be included.
Key inclusion criteria (4 listed)
- Adult patients (patients aged ≥ 18 years)
- Patients giving written informed consent to participate in the study.
- Patients with intact perfusion of both hands evidenced by a positive Allen's test.
- Patients with orthostatic intolerance will be included
Key exclusion criteria (9 listed)
- Patients with vascular implants at the sites of non-invasive BP measurement (fingers or upper arms)
- Very low perfusion in the periphery
- Arterial vascular diseases (arteriosclerosis, Raynaud's syndrome, endarteritis obliterans, collagenosis, severely advanced vascular diseases (PAOD))
- Patients with significant edema in the fingers
- Patients with atrial fibrillation
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 |
|---|---|---|
| Autonomic Function TestingAutonomic Function Testing (AFT) includes Valsalva Manoever, Deep Breathing Test, and Head-up Tilt Table Testing. | Diagnostic test | Orthostatic Intolerance Patients |
Primary outcome
Agreement of blood pressure between investigational and reference device.
Time frame: The agreement is calculated for the 5 minutes supine baseline period
The agreement of blood pressure variables [systolic, diastolic and mean pressure in mmHg [millimetres of mercury)] between both devices will be assessed by means of Scatterplot and Bland-Altman analysis.
Agreement of blood pressure between investigational and reference device.
Time frame: The agreement is calculated for 60 seconds: during (15 seconds) plus after (45 seconds) valsava maneuver
The agreement of blood pressure variables [systolic, diastolic and mean pressure in mmHg [millimetres of mercury)] between both devices will be assessed by means of Scatterplot and Bland-Altman analysis.
Agreement of blood pressure between investigational and reference device.
Time frame: The agreement is calculated for 90 seconds Deep Breathing period
The agreement of blood pressure variables [systolic, diastolic and mean pressure in mmHg [millimetres of mercury)] between both devices will be assessed by means of Scatterplot and Bland-Altman analysis.
Agreement of blood pressure between investigational and reference device.
Time frame: The agreement is calculated for 10 minutes head-up tilt table test period
The agreement of blood pressure variables [systolic, diastolic and mean pressure in mmHg [millimetres of mercury)] between both devices will be assessed by means of Scatterplot and Bland-Altman analysis.
Agreement of heart rate between investigational and reference device.
Time frame: The agreement is calculated for the 5 minutes supine baseline period
The agreement of heart rate (bpm [beats per minute)] between both devices will be assessed by means of Scatterplot and Bland-Altman analysis.
Agreement of heart rate between investigational and reference device.
Time frame: The agreement is calculated for 60 seconds: during (15 seconds) plus after (45 seconds) valsava maneuver
The agreement of heart rate (bpm [beats per minute)] between both devices will be assessed by means of Scatterplot and Bland-Altman analysis.
Agreement of heart rate between investigational and reference device.
Time frame: The agreement is calculated for 90 seconds Deep Breathing period
The agreement of heart rate (bpm [beats per minute)] between both devices will be assessed by means of Scatterplot and Bland-Altman analysis.
Agreement of heart rate between investigational and reference device.
Time frame: The agreement is calculated for 10 minutes head-up tilt table test period
The agreement of heart rate (bpm [beats per minute)] between both devices will be assessed by means of Scatterplot and Bland-Altman analysis.
Agreement of cardiac output between investigational and reference device.
Time frame: The agreement is calculated for the 5 minutes supine baseline period
The agreement of cardiac output (in l/min) between both devices will be assessed by means of Scatterplot and Bland-Altman analysis.
Agreement of cardiac output between investigational and reference device.
Time frame: The agreement is calculated for 60 seconds: during (15 seconds) plus after (45 seconds) valsava maneuver
The agreement of cardiac output (in l/min) between both devices will be assessed by means of Scatterplot and Bland-Altman analysis.
Agreement of cardiac output between investigational and reference device.
Time frame: The agreement is calculated for 90 seconds Deep Breathing period
The agreement of cardiac output (in l/min) between both devices will be assessed by means of Scatterplot and Bland-Altman analysis.
Agreement of cardiac output between investigational and reference device.
Time frame: The agreement is calculated for 10 minutes head-up tilt table test period
The agreement of cardiac output (in l/min) between both devices will be assessed by means of Scatterplot and Bland-Altman analysis.
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 18 Mar 2026.
Related trials for Autonomic Dysfunction
Not yet recruiting
Effects of Adding Vagal Neuromodulation to Manual Therapy in Women With Fibromyalgia
Fibromyalgia (FM) OR Fibromyalgia Syndrome, Manuel Therapy
Recruiting
The Effectiveness of Conservative Treatment in Patients With Complex Regional Pain Syndrome.
CRPS (Complex Regional Pain Syndromes)
Recruiting
Study of the Link Between Structural Alterations in the Hypothalamus and Cardiac Dysautonomia in Drug-resistant Epilepsy
Epilepsy, Hypothalamus
Recruiting
Effect of Raised Head of the Bed on Lying Blood Pressure in Autonomic Failure
Supine Hypertension, Autonomic Failure
Enrolling by invitationObservational study
Presentation of Young Adults With and Without Joint Hypermobility
Hypermobile Ehlers-Danlos Syndrome, Postural Orthostatic Tachycardia Syndrome (POTS)
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Autonomic Dysfunction and Orthostatic Intolerance, run by CNSystems Medizintechnik GmbH.
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 4 inclusion and 9 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 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Chief Technology Officer (00433167234560, office@cnsystems.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement of blood pressure between investigational and reference device. (time frame: The agreement is calculated for the 5 minutes supine baseline period). The study lists 12 primary outcomes in all. 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 18 Mar 2026.