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Completed

NCT Number: NCT02707744

A 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.

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Key information

Conditions

Heart Failure Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Greater Glasgow and Clyde, Glasgow, United Kingdom

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

No intervention

Other

Primary outcomes

  1. Number of Participants With an Identified Dysrhythmia on Baseline ECG Recording

    Time frame: on enrollment

    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.

Secondary outcomes

  1. 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%)

  2. 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%)

  3. Cardiovascular Mortality

    Time frame: 1 year

  4. Total Number of Hospitalisations for the Management of Heart Failure or Arrhythmia

    Time frame: 1 year

  5. 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%)

  6. 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%)

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Registry information

Official study title

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

Acronym: POP-ECG-HF-AF

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Mar 14, 2016
Registry last updated
Jul 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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