A Study of Prolonged Electrocardiographic Monitoring in Patients With Heart Failure in Sinus Rhythm or Atrial Fibrillation

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-29

Study Completion Date

2018-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

SmartWATCHes for Detection of Atrial Fibrillation

NCT02956343

Atrial Fibrillation

COMPLETED

Subclinical Atrial Fibrillation Home Monitoring in Hypertensive Patients

NCT07058831

Asymptomatic Atrial Fibrillation

RECRUITING

Evaluation of Atrial Fibrillation Occurrence in Sick Sinus and Complete Atrioventricular Block Patients After Pacemaker Implantation (AF-pacemaker Study)

NCT03303872

Post Pacemaker Implantation Patients

UNKNOWN

Testing the Accuracy of a Personal Heart Rhythm Monitor to Detect Prolonged Paroxysmal Atrial Fibrillation

NCT01917981

Paroxysmal Atrial Fibrillation Stroke

WITHDRAWN PHASE3

Using a Personal Heart Rhythm Monitor to Diagnose Paroxsymal Atrial Fibrillation in the Community

NCT01867060

Paroxysmal Atrial Fibrillation Stroke

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Failure Atrial Fibrillation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

sinus rhythm

patients with heart failure and sinus rhythm

no intervention

Intervention Type OTHER

atrial fibrillation

patients with heart failure and atrial fibrillation

no intervention

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

no intervention

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No