A Study of Prolonged Electrocardiographic Monitoring in Patients With Heart Failure in Sinus Rhythm or Atrial Fibrillation (POP-ECG-HF-AF)

Imperial College London

Status: Completed

Conditions: Atrial Fibrillation; Heart Failure

Treatments: Other: no intervention

Study type: Observational

Funder types: Other

Identifiers

NCT02707744

15IC2955

Details and patient eligibility

About

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.

Full 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

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

100 participants in 2 patient groups

sinus rhythm

Description:

patients with heart failure and sinus rhythm

Treatment:

Other: no intervention

atrial fibrillation

Description:

patients with heart failure and atrial fibrillation

Treatment:

Other: no intervention