Silent Atrial Fibrillation - Screening of High-risk Groups for Atrial Fibrillation (The Silence Study)

November 2, 2016 updated by: Valborg Heinesen, Hvidovre University Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

1622

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
  • Denmark
      • Hvidovre, Denmark, 2650
        • Recruiting
        • Hvidovre University Hospital, Department of cardiology
        • Contact:
        • Sub-Investigator:
          • Valborg Heinesen, MD
        • Sub-Investigator:
          • Annam P. Sheikh, MS
        • Sub-Investigator:
          • Julie B. Jensen, MS
  • Sweden
      • Bjurholm, Sweden
        • Active, not recruiting
        • Bjurholms Hälsocentral
      • Kalix, Sweden
        • Active, not recruiting
        • Grytnäs Hälsocentral
      • Stockholm, Sweden
        • Active, not recruiting
        • The Karolinske Institute, Department of Cardiology, Danderyd Hospital
      • Umea, Sweden
        • Active, not recruiting
        • Ålidhems hälsocentral
      • Vindeln, Sweden
        • Active, not recruiting
        • Vindelns Hälsocentral

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Heart failure
Screening for silent AF with Zenicor thumb-ECG: Patients older than 65 years, diagnosed with heart failure, without any history of atrial fibrillation, ongoing OAC treatment, implanted device or recent stroke/TIA.
Other: Screening for silent AF with Zenicor thumb-ECG
Each patient has a device for 14 days, which monitorizes their heart rhythm. They send the ecg four times daily.
Other Names:
  • Zenicor Medical Systems
Diabetes mellitus II
Screening for silent AF with Zenicor thumb-ECG: Patients older than 65 years, diagnosed with diabetes mellitus II, without any history of atrial fibrillation, ongoing OAC treatment, implanted device or recent stroke/TIA.
Other: Screening for silent AF with Zenicor thumb-ECG
Each patient has a device for 14 days, which monitorizes their heart rhythm. They send the ecg four times daily.
Other Names:
  • Zenicor Medical Systems

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with silent atrial fibrillation as assessed by handheld ECG measurements in high-risk heart failure patients.
Time Frame: 14 days
14 days
Number of participants with silent atrial fibrillation as assessed by handheld ECG measurements in high-risk type 2 diabetes patients.
Time Frame: 14 days
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with supraventricular ectopic activity.
Time Frame: 14 days
Supraventricular ectopic activity defined as three supraventricular premature beats or more as assessed by handheld ECG.
14 days
Number of participants with micro-atrial fibrillation.
Time Frame: 14 days
Micro-atrial fibrillation defined as atrial fibrillation shorter than 30 seconds or atrial runs longer than five supraventricular premature beats in a run as assessed by handheld ECG.
14 days
Number of participants with high risk of stroke in a heart failure population.
Time Frame: 2 years
High risk patients defined as patients aged 65 years or older and at least one additional risk score point without known atrial fibrillation or ongoing oral anticoagulation.
2 years
Number of participants with high risk of stroke in a type 2 diabetes population.
Time Frame: 2 years
High risk patients defined as patients aged 65 years or older and at least one additional risk score point without known atrial fibrillation or ongoing oral anticoagulation.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hvidovre University Hospital

Investigators

  • Principal Investigator: Ulrik Dixen, MD, Hvidovre University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Anticipated)

September 1, 2018

Study Completion (Anticipated)

September 1, 2020

Study Registration Dates

First Submitted

August 26, 2016

First Submitted That Met QC Criteria

September 1, 2016

First Posted (Estimate)

September 8, 2016

Study Record Updates

Last Update Posted (Estimate)

November 3, 2016

Last Update Submitted That Met QC Criteria

November 2, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-16015331

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

The ethical approval do not allow us to share individualised data.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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