the Dutch-GERAF Study

Active, not recruiting

• Conditions: Atrial Fibrillation; Frailty; Major Bleed

• Registration Number: NCT05337202
• Lead Sponsor: Dijklander Ziekenhuis

Brief Summary

Geriatric patients are at high risk of cardiovascular complications, and for the development of atrial fibrillation. Often atrial fibrillation exists in these patients without specific symptoms, and could therefore remain unknown. Furthermore, concerns exist about the bleeding profile of anticoagulation in the very elderly or frail patients.

This study applies opportunistic screening for atrial fibrillation as advised in the latest ESC Guideline on the diagnosis and management of atrial fibrillation. Furthermore, multiple bleeding risk scores will be applies, to better assess the bleeding risk in very elderly or frail patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-25
• Study First Submitted: 2022-04-13
• Study First Submitted QC: 2022-04-13
• Study First Posted: 2022-04-20
• Primary Completion: 2022-10-26
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-19
• Last Update Posted: 2024-02-20
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1075

Inclusion Criteria

All newly referred patients of 65 years and older that visit geriatric outpatient services are eligible (including Fall clinic, Memory clinic, Pre-operative geriatric assessment clinic, or any other geriatric outpatient clinics that are led by a geriatrician).

Exclusion Criteria

• The patient has a pacemaker or implantable cardioverter defibrillator.
• The patient is known with a severe dementia, MoCA ≤ 15 points.
• The patient has a severe tremor, from whatever cause, and thus is unable to use the PPG based smartphone AF detection algorithm.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Newly identified cases of atrial fibrillation	The first 6 months after recruitment for the study	PPG or ECG detected new cases of atrial fibrillation

Secondary Outcome Measures

Name	Time	Method
Stroke	From recruitment until 3 years after the recruitment of the last participant	Stroke
Death	From recruitment until 3 years after the recruitment of the last participant	Death
Major bleeding	From recruitment until 3 years after the recruitment of the last participant	Major bleeding, including intra cranial haemorrhage
Cognitive disorder	From recruitment until 3 years after the recruitment of the last participant	Development of dementia, categorized by aetiology, during follow up
New Atrial Fibrillation, developed after the screening period	From recruitment until 3 years after the recruitment of the last participant	New Atrial Fibrillation, developed after the screening period

Trial Locations

Locations (6)

Dijklander Ziekenhuis; 🇳🇱 Hoorn, Noord-Holland, Netherlands

Albert Schweitzer Ziekenhuis; 🇳🇱 Dordrecht, Netherlands

Rijnstate; 🇳🇱 Arnhem, Gelderland, Netherlands

Noordwest ziekenhuisgroep; 🇳🇱 Alkmaar, Netherlands

Meander Medisch Centrum; 🇳🇱 Amersfoort, Netherlands

Onze Lieve Vrouwe Gasthuis; 🇳🇱 Amsterdam, Netherlands