POP-ECG-HF-AF: A Study of Prolonged Electrocardiographic Monitoring in Patients With Heart Failure in Sinus Rhythm or Atrial Fibrillation
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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
Arms and Interventions
| Arm | 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
|
Outcome Measures
Primary Outcome Measures
- Identification of a dysrhythmia on baseline ECG recording [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 Outcome Measures
- 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]
- All cause mortality [1 year]
- Cardiovascular mortality [1 year]
- 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]
- 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]
Eligibility Criteria
Criteria
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:
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Myocardial infarction in the previous six weeks,
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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).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Greater Glasgow and Clyde | Glasgow | United Kingdom | ||
| 2 | Royal Brompton & Harefield NHS Foundation Trust | London | United Kingdom | UB9 6JH | |
| 3 | Northwick Park Hospital | London | United Kingdom |
Sponsors and Collaborators
- Imperial College London
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 15IC2955