N/A
Completed N=100
A Study of Prolonged Electrocardiographic Monitoring in Patients With Heart Failure in Sinus Rhythm or Atrial Fibrillation
Source: ClinicalTrials.gov NCT02707744 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Jul 2023
Primary outcomePrimary: Number of Participants With an Identified Dysrhythmia on Baseline ECG Recording — 25; 35 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With an Identified Dysrhythmia on Baseline ECG Recording |
25; 35 | — |
| 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. |
24; 18 | — |
| SECONDARY All Cause Mortality |
3; 4 | — |
| SECONDARY Cardiovascular Mortality |
— | — |
| SECONDARY Total Number of Hospitalisations for the Management of Heart Failure or Arrhythmia |
— | — |
| SECONDARY Total Number of Patients Implanted With Any Permanent Device Capable of Pacing the Heart |
16; 7 | — |
| SECONDARY Implantation of Any Permanent Device Capable of Pacing the Heart |
16; 7 | — |
Eligibility 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
- 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).
Data sourced from ClinicalTrials.gov (NCT02707744). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.