A Study of Prolonged Electrocardiographic Monitoring in Patients With Heart Failure in Sinus Rhythm or Atrial Fibrillation (POP-ECG-HF-AF)

September 9, 2022 updated by: Imperial College London

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Actual)

100

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

  • United Kingdom
      • Glasgow, United Kingdom
        • Greater Glasgow and Clyde
      • London, United Kingdom
        • Northwick Park Hospital
      • London, United Kingdom, UB9 6JH
        • Royal Brompton & Harefield NHS Foundation Trust

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

patients with heart failure

Description

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).

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
sinus rhythm
patients with heart failure and sinus rhythm
Other: no intervention
atrial fibrillation
patients with heart failure and atrial fibrillation
Other: no intervention

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
Time Frame: 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.
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.
Time Frame: 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%)
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
Time Frame: 1 year
survival status was known in 46 patients with sinus rhythm (97.9%) and 50 patients with atrial fibrillation (100%)
1 year
Cardiovascular Mortality
Time Frame: 1 year
1 year
Total Number of Hospitalisations for the Management of Heart Failure or Arrhythmia
Time Frame: 1 year
1 year
Total Number of Patients Implanted With Any Permanent Device Capable of Pacing the Heart
Time Frame: 1 year
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
Time Frame: 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%)
From date of enrollment until the date of implantation of any permanent device capable of pacing the heart, assessed up to 1 year

Collaborators and Investigators

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

Sponsor

Imperial College London

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

February 1, 2016

Primary Completion (Actual)

November 1, 2018

Study Completion (Actual)

November 1, 2018

Study Registration Dates

First Submitted

February 8, 2016

First Submitted That Met QC Criteria

March 8, 2016

First Posted (Estimated)

March 14, 2016

Study Record Updates

Last Update Posted (Actual)

July 27, 2023

Last Update Submitted That Met QC Criteria

September 9, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15IC2955

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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