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

Completed

• Conditions: Atrial Fibrillation; Heart Failure
• Interventions: Other: no intervention

• Registration Number: NCT02707744
• Lead Sponsor: Imperial College London

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-02-08
• Study First Submitted QC: 2016-03-08
• Study First Posted: 2016-03-14
• Primary Completion: 2018-11
• Study Completion: 2018-11
• Results First Submitted: 2022-03-14
• Status Verified: 2022-09
• Results First Submitted QC: 2022-09-09
• Last Update Submitted: 2022-09-09
• Results First Posted: 2023-07-27
• Last Update Posted: 2023-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Heart Failure
2. Treated with Loop Diuretics for at least six weeks
3. Willing and legally able to sign informed consent
4. At least 18 years of age
5. New York Heart Association (NYHA) class II - IV

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Exclusion Criteria

1. Myocardial infarction in the previous six weeks,
2. Implanted pacemaker, including cardiac resynchronisation device, or defibrillator
3. Already participating in an interventional randomized controlled trial assessing effects on morbidity and mortality (this study does not preclude participation in future clinical trials).

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
sinus rhythm	no intervention	patients with heart failure and sinus rhythm
atrial fibrillation	no intervention	patients with heart failure and atrial fibrillation

Primary Outcome Measures

Name	Time	Method
Number of Participants With an Identified Dysrhythmia on Baseline ECG Recording	on enrollment	A dysrhythmia will be defined as either; 1. Arrhythmia for which there is a Class I or IIa recommendation for treatment with medication or devices in ESC guidelines.; 2. 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.

Secondary Outcome Measures

Name	Time	Method
Cardiovascular Mortality	1 year
All Cause Mortality	1 year	survival status was known in 46 patients with sinus rhythm (97.9%) and 50 patients with atrial fibrillation (100%)
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.	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	information about new implantations and hospitalisations were known for 46 patients with sinus rhythm (97.9%) and 47 with atrial fibrillation (94%)
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	1 year	information about new implantations were known for 46 patients with sinus rhythm (97.9%) and 47 with atrial fibrillation (94%)
Implantation of Any Permanent Device Capable of Pacing the Heart	From date of enrollment until the date of implantation of any permanent device capable of pacing the heart, assessed up to 1 year	information about new implantations were known for 46 patients with sinus rhythm (97.9%) and 47 with atrial fibrillation (94%)

Trial Locations

Locations (3)

Northwick Park Hospital; 🇬🇧 London, United Kingdom

Greater Glasgow and Clyde; 🇬🇧 Glasgow, United Kingdom

Royal Brompton & Harefield NHS Foundation Trust; 🇬🇧 London, United Kingdom