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NCT Number: NCT07684053

Digital Screening for Atrial Fibrillation to Prevent Stroke

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Internal Medicine III, Medical University Innsbruck

Innsbruck, Tyrol, 6020, Austria

Location status: Recruiting

Location contact

Michael Schreinlechner, MD

CONTACT

[email protected]

+4351250425621

Sebastian J Reinstadler, MD, PhD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 65 years
  • Policyholder in Austria (active unique social insurance number)
  • Written electronic informed consent Exclusion Criteria

a) Currently treated with oral anticoagulation b) Cardiac implanted electronic device (CIED)

Treatment and study plan

Smartphone-based digital atrial fibrillation screening and management pathway

Device

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.

Primary outcomes

  1. Hospitalization for stroke of any type (ischemic or hemorrhagic)

    Time frame: Up to 48 months

Secondary outcomes

  1. Hospitalization for Ischemic stroke

    Time frame: Up to 48 months

  2. Hospitalization for Hemorrhagic stroke

    Time frame: Up to 48 months

  3. All-cause mortality

    Time frame: Up to 48 months

  4. Cardiovascular mortality

    Time frame: Up to 48 months

  5. Hospitalization for heart failure

    Time frame: Up to 48 months

  6. The combination of hospitalization for stroke, hospitalization for heart failure and cardiovascular death.

    Time frame: Up to 48 months

  7. Hospitalization for bleeding

    Time frame: up to 48 months

  8. Fatal bleeding

    Time frame: up to 48 months

  9. Cost and incremental cost effectiveness ratio

    Time frame: Up to 48 months

Study contacts

Contact information is provided by the study sponsor or research team.

Michael Schreinlechner, MD

CONTACT

[email protected]

Sebastian J Reinstadler, MD, PhD

CONTACT

[email protected]

+4351250425621

Sponsors and collaborators

Lead sponsor

Medical University Innsbruck

Other

Collaborators

  • AIT Austrian Institute of Technology GmbH
  • Medical University of Graz
  • UMIT Tirol

Registry information

Official study title

Digital Screening for Atrial Fibrillation to Prevent Stroke: The Randomized Austrian Digital Heart Study

Acronym: ADHP

Important dates

Study start
2026
Primary completion
2031
Study completion
2032
First posted
Jul 6, 2026
Registry last updated
Jul 6, 2026

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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