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Not yet recruiting NCT05977335

Continuous and Non-invasive Measurements by Task Force® CORE/CARDIO in Autonomic Function Testing (AFT)

— Observational Autonomic Dysfunction Orthostatic Intolerance

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Autonomic Function Testing.
Who it may be relevant to
Registry conditions: Autonomic Dysfunction, Orthostatic Intolerance. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Diagnostic test Autonomic Function Testing
    Autonomic Function Testing (AFT) includes Valsalva Manoever, Deep Breathing Test, and Head-up Tilt Table Testing.

Primary outcome measures

  • Agreement of blood pressure between investigational and reference device. [Time frame: The agreement is calculated for the 5 minutes supine baseline period]
  • 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]
  • Agreement of blood pressure between investigational and reference device. [Time frame: The agreement is calculated for 90 seconds Deep Breathing period]
  • Agreement of blood pressure between investigational and reference device. [Time frame: The agreement is calculated for 10 minutes head-up tilt table test period]
  • Agreement of heart rate between investigational and reference device. [Time frame: The agreement is calculated for the 5 minutes supine baseline period]
  • 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]
  • Agreement of heart rate between investigational and reference device. [Time frame: The agreement is calculated for 90 seconds Deep Breathing period]
  • Agreement of heart rate between investigational and reference device. [Time frame: The agreement is calculated for 10 minutes head-up tilt table test period]
  • Agreement of cardiac output between investigational and reference device. [Time frame: The agreement is calculated for the 5 minutes supine baseline period]
  • 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]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT05977335 · AFTs Task Force® CORE/CARD

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗