Department of Internal Medicine III, Medical University Innsbruck
Innsbruck, Tyrol, 6020, Austria
Location status: Recruiting
Location contact
Michael Schreinlechner, MD
CONTACT
Sebastian J Reinstadler, MD, PhD
CONTACT
NCT Number: NCT07684053
The Austrian Digital Heart Study is a population-based, siteless, randomized, controlled digital trial testing whether a smartphone-based atrial fibrillation screening and management pathway reduces stroke hospitalizations compared with usual care. Adults aged 65 years or older in Austria are randomized to either a digital intervention using the 'Pulskontrolle' app or to usual care. The intervention includes smartphone-camera photoplethysmography for atrial fibrillation screening, confirmatory 7-day ECG patch monitoring in case of suspected atrial fibrillation, and digital education and management support. The primary outcome is hospitalization for stroke of any type within 48 months.
Interested in participating?
Request Info65 year and older
All sexes
Interventional
Not applicable
Innsbruck, Tyrol, 6020, Austria
Location status: Recruiting
Michael Schreinlechner, MD
CONTACT
Sebastian J Reinstadler, MD, PhD
CONTACT
Atrial fibrillation is common in older adults, often remains undetected, and is a major risk factor for stroke, heart failure, hospitalization, and death. Digital screening using smartphone-based photoplethysmography provides substantial benefits in detecting atrial fibrillation compared to usual care, but it remains unclear whether such screening improves clinical outcomes.
The Austrian Digital Heart Study tests a brand-independent digital atrial fibrillation screening and management pathway embedded in the Austrian public health-care system. Participants randomized to the intervention arm use the 'Pulskontrolle' smartphone application for repeated photoplethysmographic pulse-wave (PPG) recordings. If atrial fibrillation is suspected, confirmatory 7-day ECG patch monitoring is initiated. Participants with positive PPG receive structured digital information, telehealth support, and guideline-oriented management recommendations.
The control arm receives usual care without active app-based atrial fibrillation screening. The primary endpoint is hospitalization for stroke of any type within 48 months after randomization. Secondary outcomes include mortality, cardiovascular morbidity, bleeding, atrial fibrillation-related outcomes, health-care utilization, and health-economic endpoints.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
a) Currently treated with oral anticoagulation b) Cardiac implanted electronic device (CIED)
Participants randomized to the digital intervention arm receive access to a smartphone-based atrial fibrillation screening and management pathway. The intervention includes photoplethysmography-based pulse wave measurements using a CE-certified smartphone application, followed by confirmatory 7-day ECG patch monitoring in participants with abnormal findings suggestive of atrial fibrillation. Participants with suspected or confirmed atrial fibrillation receive structured digital information, adherence support, and the option of telehealth guidance to facilitate guideline-oriented care. Treatment decisions remain the responsibility of the participant's usual treating physician.
Time frame: Up to 48 months
Time frame: Up to 48 months
Time frame: Up to 48 months
Time frame: Up to 48 months
Time frame: Up to 48 months
Time frame: Up to 48 months
Time frame: Up to 48 months
Time frame: up to 48 months
Time frame: up to 48 months
Time frame: Up to 48 months
Contact information is provided by the study sponsor or research team.
Michael Schreinlechner, MD
CONTACT
Sebastian J Reinstadler, MD, PhD
CONTACT
Medical University Innsbruck
Other
Digital Screening for Atrial Fibrillation to Prevent Stroke: The Randomized Austrian Digital Heart Study
Acronym: ADHP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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