Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sinus rhythm | patients with heart failure and sinus rhythm |
| |
| atrial fibrillation | patients with heart failure and atrial fibrillation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| no intervention | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With an Identified Dysrhythmia on Baseline ECG Recording | A dysrhythmia will be defined as either
| on enrollment |
| 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. | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
patients with heart failure
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Greater Glasgow and Clyde | Glasgow | United Kingdom | ||||
| Royal Brompton & Harefield NHS Foundation Trust |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Sinus Rhythm | patients with heart failure and sinus rhythm no intervention |
| FG001 | Atrial Fibrillation | patients with heart failure and atrial fibrillation no intervention |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sinus Rhythm | patients with heart failure and sinus rhythm no intervention |
| BG001 | Atrial Fibrillation | patients with heart failure and atrial fibrillation no intervention |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With an Identified Dysrhythmia on Baseline ECG Recording | A dysrhythmia will be defined as either
| Posted | Count of Participants | Participants | on enrollment |
|
1 year
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sinus Rhythm | patients with heart failure and sinus rhythm no intervention | 3 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yura Mareev | Imperial College | +79166364410 | mareev84@gmail.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Sep 23, 2015 | Mar 12, 2022 | Prot_SAP_ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001145 | Arrhythmias, Cardiac |
| D010335 | Pathologic Processes |
Not provided
Not provided
Not provided
Not provided
Not provided
| All Cause Mortality | survival status was known in 46 patients with sinus rhythm (97.9%) and 50 patients with atrial fibrillation (100%) | 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 | 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 | 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 |
| London |
| UB9 6JH |
| United Kingdom |
| Northwick Park Hospital | London | United Kingdom |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Atrial Fibrillation |
patients with heart failure and atrial fibrillation no intervention |
|
|
| 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%) | Posted | Count of Participants | Participants | 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 |
|
|
|
| Secondary | All Cause Mortality | survival status was known in 46 patients with sinus rhythm (97.9%) and 50 patients with atrial fibrillation (100%) | Posted | Count of Participants | Participants | 1 year |
|
|
|
| Secondary | Cardiovascular Mortality | Not Posted | 1 year | Participants |
| Secondary | Total Number of Hospitalisations for the Management of Heart Failure or Arrhythmia | Not Posted | 1 year | Participants |
| 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%) | Posted | Count of Participants | Participants | 1 year |
|
|
|
| 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%) | Posted | Count of Participants | Participants | From date of enrollment until the date of implantation of any permanent device capable of pacing the heart, assessed up to 1 year |
|
|
|
| 46 |
| 0 |
| 47 |
| 0 |
| 47 |
| EG001 | Atrial Fibrillation | patients with heart failure and atrial fibrillation no intervention | 4 | 50 | 0 | 50 | 0 | 50 |
Not provided
Not provided
Not provided
| D013568 |
| Pathological Conditions, Signs and Symptoms |