Clinical trial NCT02893215: Silent Atrial Fibrillation - Screening of High-risk Groups for Atrial Fibrillation (The Silence Study)
Official title: Silent Atrial Fibrillation - Screening of High-risk Groups for Atrial Fibrillation (The Silence Study)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2016-09-08
Enrollment: 1622
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with congestive heart failure and without any history of atrial fibrillation, ongoing OAC treatment, implanted device or recent stroke/TIA

Patients with DM-II and without any history of atrial fibrillation, ongoing OAC treatment, implanted device or recent stroke/TIA

Brief summary: The primary aim of the present study is to screen high-risk type 2 diabetes patients and heart failure patients without any history of atrial fibrillation (AF), ongoing oral anticoagulation (OAC) treatment, implanted device or recent stroke/Transient Ischemic Attack (TIA), for silent AF.

Moreover, we aim to establish the prevalence of two or more risk factors for stroke in patients with heart failure and diabetes mellitus type 2 (DM2) with the aim of assessing the feasibility for this group to undergo AF screening.

Overall, the aim of the study is to prevent stroke in high-risk patients groups through identification of silent (asymptomatic) atrial fibrillation.

Detailed description: The number of screened patients with respectively heart failure and type 2 diabetes with a risk score (Congestive Heart Failure, Hypertension, Aged 75 years or older, Diabetes, Stroke / transient cerebral ischemia, Vascular disease, Aged 65 years or older and Sex category (CHADSVASc)) of two or more, the number of these patients excluded due to AF or ongoing AF, the number of eligible patients not included for other reasons, and, finally, number of included patients will be listed.

Patients eligible for screening will be supplied with a hand-held ECG-recorder developed by Zenicor Medical Systems (www.zenicor.com) and will transmit recordings 4 times daily (morning, midday, evening -at meals - and before bedtime) and in case of symptoms, for 14 days.

The transmitted ECGs will be digitally stored, analyzed and screened for AF. All AF episodes will recorded and the day and time of the arrhythmia will be registered.

Eligible patients will be given brief oral and the more thorough written patient information about the study, and offered an appointment for the first meeting, which will happen in the Cardiological out-patient clinic in Copenhagen University Hospital (Hvidovre) with a member of the project group. During the first meeting, the patient will get more information about the study and has the possibility to ask questions. If the patient wants to bring a relative or friend already at this meeting, this can be arranged. If the patient meets the criteria and is interested in participation he/she will be invited to participation in the study. The patient gets the rest of the information material, i.e. written informed consent declaration, and is given a period for questioning and consideration of participation for at least three days. If the patient wants another visit for further information and possibly with participation of a relative or friend, such a visit is scheduled, and the patient can be included at this visit, and written informed consent declaration can be given to the project group member.

Heart failure patients will have a standardized echocardiography and diabetes patients will have supplementary registration of HbA1c, and latest blood glucose value. The latest level of creatinine and creatinine clearance will be registered for all patients (DM2 and congestive heart failure (CHF)).

Every patient is given a Study identification (ID) number and there will be a key file linking this number and the patient ID; thus, the dataset is anonymized.

All ECG's will be analyzed using a soft ware based algorithm which has been developed in order to exclude normal recordings (sinus rhythm without irregularities).

Patients with newly detected AF will be referred to the local cardiology out-patient clinic or if present OAC clinic for treatment according to established guidelines including OAC treatment. Here the patients will be informed about the options of OAC treatment, the reasons why we want to offer it, including the risk of developing cerebral ischemic stroke, precautions with this treatment and the risks connected to OAC treatment. The treatment with OAC is not a part of the screening study.

Eligibility criteria: Inclusion Criteria:

* Systolic Congestive Heart Failure diagnosed by echocardiography showing a left ventricular ejection fraction (LVEF) ≤ 40%.
* Diagnosed Diabetes Mellitus type II.
* Age 65 years or older
* CHADS-Vasc (Risk score) 2 or higher

Exclusion Criteria:

* Previous history of AF
* Ongoing OAC treatment
* Implanted device
* Recent stroke/TIA

Primary outcomes:
measure: Number of participants with silent atrial fibrillation as assessed by handheld ECG measurements in high-risk heart failure patients.
timeFrame: 14 days
measure: Number of participants with silent atrial fibrillation as assessed by handheld ECG measurements in high-risk type 2 diabetes patients.
timeFrame: 14 days
Secondary outcomes:
measure: Number of participants with supraventricular ectopic activity.
timeFrame: 14 days
measure: Number of participants with micro-atrial fibrillation.
timeFrame: 14 days
measure: Number of participants with high risk of stroke in a heart failure population.
timeFrame: 2 years
measure: Number of participants with high risk of stroke in a type 2 diabetes population.
timeFrame: 2 years
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Department of Cardiology, Krankenhaus der Elisabethinen
city: Linz
country: Austria
facility: Kepler Universitätsklinikum GmbH
city: Linz
country: Austria
facility: Krankenhaus der Barmherzigen Brüder Linz
city: Hvidovre
country: Denmark
facility: Hvidovre University Hospital, Department of cardiology
city: Bjurholm
country: Sweden
facility: Bjurholms Hälsocentral
city: Kalix
country: Sweden
facility: Grytnäs Hälsocentral
city: Stockholm
country: Sweden
facility: The Karolinske Institute, Department of Cardiology, Danderyd Hospital
city: Umea
country: Sweden
facility: Ålidhems Hälsocentral
city: Vindeln
country: Sweden
facility: Vindelns Hälsocentral
Study officials:
affiliation: Hvidovre University Hospital
name: Ulrik Dixen, MD
role: PRINCIPAL_INVESTIGATOR
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