Heart FailurePOP-ECG-HF-AFNCT02707744
A Study of Prolonged Electrocardiographic Monitoring in Patients With Heart Failure in Sinus Rhythm or Atrial Fibrillation
An observational study of Heart Failure and Atrial Fibrillation, run by Imperial College London at 3 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Atrial Fibrillation
- How many people
- 100 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Feb 2016to Nov 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with heart failure
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Greater Glasgow and Clyde
Glasgow
Royal Brompton & Harefield NHS Foundation Trust
London, UB9 6JH
Northwick Park Hospital
London
About this study
Official title: 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.
Read the 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
- Conditions
- Heart Failure, Atrial Fibrillation
- Being tested
- no intervention
- Keywords
- Heart Failure, Atrial Fibrillation, Ambulatory ECG monitor
- Medical subject headings
- Heart Failure, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
| Study group | Role | What they receive |
|---|---|---|
| sinus rhythm | patients with heart failure and sinus rhythm Receives: Other: no intervention | |
| atrial fibrillation | patients with heart failure and atrial fibrillation Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: on enrollment
Secondary outcomes (6)
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%)
Measured: 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%)
Measured: 1 year
Cardiovascular Mortality
Measured: 1 year
Total Number of Hospitalisations for the Management of Heart Failure or Arrhythmia
Measured: 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%)
Measured: 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%)
Measured: From date of enrollment until the date of implantation of any permanent device capable of pacing the heart, assessed up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completionNov 2018
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02707744
- Sponsor's protocol ID
- 15IC2955
- Acronym
- POP-ECG-HF-AF
- Status last verified
- Sep 2022
- First submitted
- 8 Feb 2016
- Last updated
- 27 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study of Prolonged Electrocardiographic Monitoring in Patients With Heart Failure in Sinus Rhythm or Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT02707744
- Acronym / sponsor ID
- POP-ECG-HF-AF / 15IC2955
- Conditions
- Heart Failure, Atrial Fibrillation
- Keywords
- Heart Failure, Atrial Fibrillation, Ambulatory ECG monitor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Nov 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 14 Mar 2016 (estimated)
- Results
- Posted 27 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sinus rhythm | – | Other: no interventionpatients with heart failure and sinus rhythm |
| atrial fibrillation | – | Other: no interventionpatients with heart failure and atrial fibrillation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with heart failure
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no intervention | Other | atrial fibrillation, sinus rhythm |
Primary outcome
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.
6 secondary outcomes
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
All Cause Mortality
Time frame: 1 year
Cardiovascular Mortality
Time frame: 1 year
Total Number of Hospitalisations for the Management of Heart Failure or Arrhythmia
Time frame: 1 year
Total Number of Patients Implanted With Any Permanent Device Capable of Pacing the Heart
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Atrial Fibrillation, run by Imperial College London at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With an Identified Dysrhythmia on Baseline ECG Recording (time frame: on enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.