the Dutch-GERAF Study

NCT05337202 | Active Not Recruiting

• 1 other identifier: WB 694
• Study Type: observational
• Target: 1,075
• Locations: 1 country
• Sites: 6

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.

Conditions

Atrial Fibrillation; Frailty; Major Bleed

Keywords

Atrial Fibrillation; Frailty; Major Bleed; Intra cranial Haemorrhage; Cognitive disorder; eHealth

Outcome Measures

Primary Outcomes (1)

• Newly identified cases of atrial fibrillation

  PPG or ECG detected new cases of atrial fibrillation

  The first 6 months after recruitment for the study

Secondary Outcomes (5)

• Major bleeding

  From recruitment until 3 years after the recruitment of the last participant

• Stroke

  From recruitment until 3 years after the recruitment of the last participant

• Death

  From recruitment until 3 years after the recruitment of the last participant

• Cognitive disorder

  From recruitment until 3 years after the recruitment of the last participant

• New Atrial Fibrillation, developed after the screening period

  From recruitment until 3 years after the recruitment of the last participant

Interventions

HeartSDK DEVICE

The photoplethysmography (PPG) application enables patients to perform a finger tip heartbeat measurement and automatic analysis

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All newly referred patients of 65 years and older that visit a geriatric outpatient service. These will form a cohort of very elderly individuals, with multi morbidity, polypharmacy, cognitive disorders, high frailty and high risk for falling. They can also be seen as a group at high risk of cardiovascular complication and/or the development of cognitive disorders.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dijklander Ziekenhuis: lead

Study Sites (6)

Rijnstate

Arnhem, Gelderland, 6815 AD, Netherlands

Location

Dijklander Ziekenhuis

Hoorn, North Holland, 1624NP, Netherlands

Location

Noordwest ziekenhuisgroep

Alkmaar, 1815 JD, Netherlands

Location

Meander Medisch Centrum

Amersfoort, 3813 TZ, Netherlands

Location

Onze Lieve Vrouwe Gasthuis

Amsterdam, 1091 AC, Netherlands

Location

Albert Schweitzer Ziekenhuis

Dordrecht, 3318 AT, Netherlands

Location

Related Publications (8)

• Zwart LAR, Germans T, Simsek S, Ruiter JH, Jansen RWMM. Atrial fibrillation, anticoagulation and major bleeding in geriatric patients at risk of falling. OBM Geriatrics 2019, Volume 3, Issue 3, doi:10.21926/obm.geriatr.1903071

  BACKGROUND

• Mol D, Riezebos RK, Marquering HA, Werner ME, Lobban TCA, de Jong JSSG, de Groot JR. Performance of an automated photoplethysmography-based artificial intelligence algorithm to detect atrial fibrillation. Cardiovasc Digit Health J. 2020 Oct 22;1(2):107-110. doi: 10.1016/j.cvdhj.2020.08.004. eCollection 2020 Sep-Oct. No abstract available.

  PMID: 35265881 BACKGROUND

• Hindricks G, Potpara T, Dagres N, Arbelo E, Bax JJ, Blomstrom-Lundqvist C, Boriani G, Castella M, Dan GA, Dilaveris PE, Fauchier L, Filippatos G, Kalman JM, La Meir M, Lane DA, Lebeau JP, Lettino M, Lip GYH, Pinto FJ, Thomas GN, Valgimigli M, Van Gelder IC, Van Putte BP, Watkins CL; ESC Scientific Document Group. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): The Task Force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC) Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC. Eur Heart J. 2021 Feb 1;42(5):373-498. doi: 10.1093/eurheartj/ehaa612. No abstract available.

  PMID: 32860505 RESULT

• Zwart LA, Jansen RW, Ruiter JH, Germans T, Simsek S, Hemels ME. Opportunistic screening for atrial fibrillation with a single lead device in geriatric patients. J Geriatr Cardiol. 2020 Mar;17(3):149-154. doi: 10.11909/j.issn.1671-5411.2020.03.007.

  PMID: 32280331 RESULT

• Searle SD, Mitnitski A, Gahbauer EA, Gill TM, Rockwood K. A standard procedure for creating a frailty index. BMC Geriatr. 2008 Sep 30;8:24. doi: 10.1186/1471-2318-8-24.

  PMID: 18826625 RESULT

• Rockwood K, Mitnitski A. Frailty in relation to the accumulation of deficits. J Gerontol A Biol Sci Med Sci. 2007 Jul;62(7):722-7. doi: 10.1093/gerona/62.7.722.

  PMID: 17634318 RESULT

• Moraes JL, Rocha MX, Vasconcelos GG, Vasconcelos Filho JE, de Albuquerque VHC, Alexandria AR. Advances in Photopletysmography Signal Analysis for Biomedical Applications. Sensors (Basel). 2018 Jun 9;18(6):1894. doi: 10.3390/s18061894.

  PMID: 29890749 RESULT

• Dutch-GERAF investigators; Zwart LAR, Spruit JR, Hemels MEW, de Groot JR, Pisters R, Riezebos RK, Jansen RWMM. Design of the Dutch multicentre study on opportunistic screening of geriatric patients for atrial fibrillation using a smartphone PPG app: the Dutch-GERAF study. Neth Heart J. 2024 May;32(5):200-205. doi: 10.1007/s12471-024-01868-6. Epub 2024 Apr 15.

  PMID: 38619715 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Full blood

MeSH Terms

Conditions

Atrial Fibrillation; Frailty; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• René Jansen, PhD

  Northwest Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2022
• First Posted: April 20, 2022
• Study Start: January 25, 2021
• Primary Completion: October 26, 2022
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 20, 2024

Record last verified: 2024-02

Locations

NL (6)