Elevated cardiovascular risk profile, Heart Failure, Atrial Fibrillation
Conditions
Interventions
Group 1: Participants without known cardiovascular disease or elevated risk profile (Visit 1: baseline assessment
Visit 2: driving experiment including stationary recordings, standardized real-world driving and a stress-inducing driving course)
Group 2: Participants without diagnosed cardiovascular disease but wi
Visit 2: driving experiment including stationary recordings, standardized real-world driving and a stress-inducing driving course)
Group 3: Individuals diagnosed with heart failure with preserved ejec
Visit 2: driving experiment including stationary recordings, standardized real-world driving and a stress-inducing driving course)
Group 4: "Individuals diagnosed with heart failure with reduced eject
Visit 2: driving experiment including stationary recordings, standardized real-world driving and a stress-inducing driving course)
Group 5: Individuals diagnosed with persistent atrial fibrillation (V
Visit 2: driving experiment including stationary recordings, standardized real-world driving and a stress-inducing driving course)
Sponsors
Klinik für Herz-, Thorax- und Gefäßchirurgie des Deutschen Herzzentrum der Charité
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Signed informed consent form - Legal and medical prerequisites for operating a motor vehicle in public traffic. - Group-specific criteria: a) No cardiovascular disease and none of the following cardiovascular risk factors: arterial hypertension, dyslipidemia, diabetes mellitus, obesity, nicotine use or positive family history b) Arterial hypertension AND diabetes mellitus OR dyslipidemia; additional cardiovascular risk factors (as listed above) are permitted c) Left ventricular ejection fraction (LVEF) =50% and NT-proBNP >125 pg/ml and either left ventricular hypertrophy, left atrial dilatation or diastolic dysfunction d) LVEF <40% e) Persistent atrial fibrillation for at least 24 hours
Exclusion criteria
Exclusion criteria: - Inability to comply with the measurement protocol - Driving experience of less than 2 years - No valid driver’s license - Pregnancy - Active malignancy - Chronic infection or uncontrolled autoimmune disease - History of stroke with residual symptoms or currently treated neurological disorders - Presence of an implanted pacemaker - Maximum exercise capacity 75 kg body weight) or <1 W/kg (=75 kg) during cardiopulmonary exercise testing (fitness for travel) - Acute infection at the time of measurement or within 5 days prior to measurement - Group-specific exclusions: a) Presence of cardiovascular disease, current cardiovascular medication, or any cardiovascular risk factor (as defined above) b) Presence of cardiovascular disease c) Atrial fibrillation at the time of examination, home oxygen therapy d) Atrial fibrillation at the time of examination, presence of LVAD or RVAD, NYHA class III–IV, end-organ damage, appropriate ICD shocks, persistent volume overload, more than one hospitalization for acute decompensation within the last 12 months, systolic blood pressure <90 mmHg or estimated cardiac index <2.4 L/min/m² on echocardiography e) Absence of atrial fibrillation at the time of examination
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Median Absolute Percentage Error (MdAPE) of the collected measurements compared to the reference standard of a medical-grade device =10%, evaluated over the entire recording period and analyzed after completion of the driving trial. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Percentage of measurements within predefined tolerance ranges: heart rate ±5 bpm, arterial blood pressure ±5 mmHg, respiratory rate ±2 breaths/min, oxygen saturation ±2% determined over the duration of the recording period and evaluated upon completion of the driving trial. - F1 score, precision and recall for the detection of arrhythmias as well as pathological respiratory or cardiac sounds determined over the duration of the recording period and evaluated upon completion of the driving trial. - Duration of valid ECG recordings during traversal of the predefined test route evaluated upon completion of the driving trial. - Duration of valid video-based vital sign acquisition during traversal of the test route evaluated upon completion of the driving trial. - Intergroup differences in heart rate variability during rest and under stress conditions within the driving experiment. - Difference in autonomic responses to stress and during the recovery phase between the groups in the final part of the driving trial. - Correlation between the time span from door opening ? exiting ? door closing and door opening ? entering ? door closing during the stationary trial and performance in the Timed Up and Go test at the basic assessment. | — |
Countries
Germany
Contacts
Public ContactDominik Naumann
Deutsches Herzzentrum der Charité
Outcome results
None listed