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

Heart Failure Clinical Trial

— POP-ECG-HF-AF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02707744
• Other study ID #: 15IC2955
• Status: Completed
• Start date: February 2016
• Est. completion date: November 2018

Study information

• Verified date: September 2022
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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).

Related Conditions & MeSH terms

• Atrial Fibrillation
• Heart Failure

Intervention

Other:
• no intervention

Locations

Country	Name	City	State
United Kingdom	Greater Glasgow and Clyde	Glasgow
United Kingdom	Northwick Park Hospital	London
United Kingdom	Royal Brompton & Harefield NHS Foundation Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	All Cause Mortality	survival status was known in 46 patients with sinus rhythm (97.9%) and 50 patients with atrial fibrillation (100%)	1 year
Secondary	Cardiovascular Mortality		1 year
Secondary	Total Number of Hospitalisations for the Management of Heart Failure or Arrhythmia		1 year
Secondary	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
Secondary	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