Atrial Fibrillation, Heart Failure
Conditions
Keywords
Heart Failure, Atrial Fibrillation, Ambulatory ECG monitor
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.
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
Interventions
OTHERno intervention
Sponsors
Imperial College London
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With an Identified Dysrhythmia on Baseline ECG Recording | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All Cause Mortality | 1 year | survival status was known in 46 patients with sinus rhythm (97.9%) and 50 patients with atrial fibrillation (100%) |
| Cardiovascular Mortality | 1 year | — |
| 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 | information about new implantations and hospitalisations were known for 46 patients with sinus rhythm (97.9%) and 47 with atrial fibrillation (94%) |
| Total Number of Patients Implanted With Any Permanent Device Capable of Pacing the Heart | 1 year | information about new implantations were known for 46 patients with sinus rhythm (97.9%) and 47 with atrial fibrillation (94%) |
| 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 | information about new implantations were known for 46 patients with sinus rhythm (97.9%) and 47 with atrial fibrillation (94%) |
| Total Number of Hospitalisations for the Management of Heart Failure or Arrhythmia | 1 year | — |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sinus Rhythm patients with heart failure and sinus rhythm
no intervention | 47 |
| Atrial Fibrillation patients with heart failure and atrial fibrillation
no intervention | 50 |
| Total | 97 |
Baseline characteristics
| Characteristic | Sinus Rhythm | Total | Atrial Fibrillation |
|---|---|---|---|
| Age, Continuous | 68 years | 75 years | 78 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 7 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 38 Participants | 86 Participants | 48 Participants |
| Region of Enrollment United Kingdom | 47 participants | 97 participants | 50 participants |
| Sex: Female, Male Female | 12 Participants | 29 Participants | 17 Participants |
| Sex: Female, Male Male | 35 Participants | 68 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 46 | 4 / 50 |
| other Total, other adverse events | 0 / 47 | 0 / 50 |
| serious Total, serious adverse events | 0 / 47 | 0 / 50 |
Outcome results
Primary
Number of Participants With an Identified Dysrhythmia on Baseline ECG Recording
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.
Time frame: on enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sinus Rhythm | Number of Participants With an Identified Dysrhythmia on Baseline ECG Recording | 25 Participants |
| Atrial Fibrillation | Number of Participants With an Identified Dysrhythmia on Baseline ECG Recording | 35 Participants |
Secondary
All Cause Mortality
survival status was known in 46 patients with sinus rhythm (97.9%) and 50 patients with atrial fibrillation (100%)
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sinus Rhythm | All Cause Mortality | 3 Participants |
| Atrial Fibrillation | All Cause Mortality | 4 Participants |
Secondary
Cardiovascular Mortality
Time frame: 1 year
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%)
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sinus Rhythm | 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. | 24 Participants |
| Atrial Fibrillation | 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. | 18 Participants |
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%)
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sinus Rhythm | Implantation of Any Permanent Device Capable of Pacing the Heart | 16 Participants |
| Atrial Fibrillation | Implantation of Any Permanent Device Capable of Pacing the Heart | 7 Participants |
Secondary
Total Number of Hospitalisations for the Management of Heart Failure or Arrhythmia
Time frame: 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%)
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sinus Rhythm | Total Number of Patients Implanted With Any Permanent Device Capable of Pacing the Heart | 16 Participants |
| Atrial Fibrillation | Total Number of Patients Implanted With Any Permanent Device Capable of Pacing the Heart | 7 Participants |