A Study of Prolonged Electrocardiographic Monitoring in Patients With Heart Failure in Sinus Rhythm or Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
It is an observational study in patients with heart failure investigating the incidence of arrhythmias using a wearable device which can monitor heart rhythm for up to 14 days. In addition to gathering routine clinical information, research assessments include a symptoms questionnaire and a corridor walk test. Patients will be followed for clinical events (interventions for arrhythmias, hospitalisation, death) for 1 year.

Detailed Description
-----------------
due to the slow recruitment, on the one hand, and the fact that the preliminary analysis gave the valuable results, on the other hand, the number of patients was reduced from 400 to 100 and the follow-up from five years to one year

Official Title
-----------------
A Prospective Observational Study of Prolonged Electrocardiographic Monitoring in Patients With Heart Failure in Sinus Rhythm or Atrial Fibrillation

Conditions
-----------------
Heart Failure, Atrial Fibrillation

Intervention / Treatment
-----------------
* Other: no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Heart Failure Treated with Loop Diuretics for at least six weeks Willing and legally able to sign informed consent At least 18 years of age New York Heart Association (NYHA) class II - IV Exclusion Criteria: Myocardial infarction in the previous six weeks, Implanted pacemaker, including cardiac resynchronisation device, or defibrillator Already participating in an interventional randomized controlled trial assessing effects on morbidity and mortality (this study does not preclude participation in future clinical trials).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| sinus rhythm<br>patients with heart failure and sinus rhythm | Other: no intervention<br> <br> |
| atrial fibrillation<br>patients with heart failure and atrial fibrillation | Other: no intervention<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With an Identified Dysrhythmia on Baseline ECG Recording | A dysrhythmia will be defined as either Arrhythmia for which there is a Class I or IIa recommendation for treatment with medication or devices in ESC guidelines. One or more of the following even if it does not otherwise meet guideline-indication for treatment: Sinus bradycardia ≤30bpm for ≥one minute High-degree atrioventricular (AV) block (3rd degree or Mobitz Type I or II) Pauses lasting ≥3 seconds (either sinus or AV block) Frequent ventricular ectopy defined as >1,000 ectopic beats per day. Ventricular tachycardia with rate ≥100 bpm for ≥5 beats. | on enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined Endpoint Made up of Cardiovascular Mortality or Hospitalisation for the Management of Heart Failure/Arrhythmia or Implantation of Any Permanent Device Capable of Pacing the Heart. | information about new implantations and hospitalisations were known for 46 patients with sinus rhythm (97.9%) and 47 with atrial fibrillation (94%) | From date of enrollment until the date of first hospitalization for management of heart failure/arrhythmia or date of implantation of any permanent device capable of pacing the heart or cardiovascular death, whichever came first, assessed up to 1 years | 
| All Cause Mortality | survival status was known in 46 patients with sinus rhythm (97.9%) and 50 patients with atrial fibrillation (100%) | 1 year | 
| Cardiovascular Mortality |  | 1 year | 
| Total Number of Hospitalisations for the Management of Heart Failure or Arrhythmia |  | 1 year | 
| Total Number of Patients Implanted With Any Permanent Device Capable of Pacing the Heart | information about new implantations were known for 46 patients with sinus rhythm (97.9%) and 47 with atrial fibrillation (94%) | 1 year | 
| Implantation of Any Permanent Device Capable of Pacing the Heart | information about new implantations were known for 46 patients with sinus rhythm (97.9%) and 47 with atrial fibrillation (94%) | From date of enrollment until the date of implantation of any permanent device capable of pacing the heart, assessed up to 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart Failure, Atrial Fibrillation, Ambulatory ECG monitor