Clinical trial NCT02707744: A Study of Prolonged Electrocardiographic Monitoring in Patients With Heart Failure in Sinus Rhythm or Atrial Fibrillation
Official title: A Prospective Observational Study of Prolonged Electrocardiographic Monitoring in Patients With Heart Failure in Sinus Rhythm or Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Atrial Fibrillation
Keywords: Heart Failure
Atrial Fibrillation
Ambulatory ECG monitor
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2016-03-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with heart failure

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

Eligibility criteria: 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).

Primary outcomes:
measure: Number of Participants With an Identified Dysrhythmia on Baseline ECG Recording
timeFrame: on enrollment
Secondary outcomes:
measure: 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.
timeFrame: 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
measure: All Cause Mortality
timeFrame: 1 year
measure: Cardiovascular Mortality
timeFrame: 1 year
measure: Total Number of Hospitalisations for the Management of Heart Failure or Arrhythmia
timeFrame: 1 year
measure: Total Number of Patients Implanted With Any Permanent Device Capable of Pacing the Heart
timeFrame: 1 year
measure: Implantation of Any Permanent Device Capable of Pacing the Heart
timeFrame: From date of enrollment until the date of implantation of any permanent device capable of pacing the heart, assessed up to 1 year
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Greater Glasgow and Clyde
city: London
country: United Kingdom
facility: Royal Brompton & Harefield NHS Foundation Trust
city: London
country: United Kingdom
facility: Northwick Park Hospital
Study officials:
References: