Trial Outcomes & Findings for A Study of Prolonged Electrocardiographic Monitoring in Patients With Heart Failure in Sinus Rhythm or Atrial Fibrillation (NCT NCT02707744)

Results Overview

A dysrhythmia will be defined as either 1. Arrhythmia for which there is a Class I or IIa recommendation for treatment with medication or devices in ESC guidelines. 2. One or more of the following even if it does not otherwise meet guideline-indication for treatment: * Sinus bradycardia ≤30bpm for ≥one minute * High-degree atrioventricular (AV) block (3rd degree or Mobitz Type I or II) * Pauses lasting ≥3 seconds (either sinus or AV block) * Frequent ventricular ectopy defined as \>1,000 ectopic beats per day. * Ventricular tachycardia with rate ≥100 bpm for ≥5 beats.

Recruitment status

COMPLETED

Target enrollment

100 participants

Primary outcome timeframe

on enrollment

Results posted on

2023-07-27

Participant Flow

Participant milestones

Participant milestones
Measure	Sinus Rhythm patients with heart failure and sinus rhythm no intervention	Atrial Fibrillation patients with heart failure and atrial fibrillation no intervention
Overall Study STARTED	50	50
Overall Study COMPLETED	47	50
Overall Study NOT COMPLETED	3	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sinus Rhythm n=47 Participants patients with heart failure and sinus rhythm no intervention	Atrial Fibrillation n=50 Participants patients with heart failure and atrial fibrillation no intervention	Total n=97 Participants Total of all reporting groups
Age, Continuous	68 years n=5 Participants	78 years n=7 Participants	75 years n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	17 Participants n=7 Participants	29 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants	33 Participants n=7 Participants	68 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	7 Participants n=5 Participants	0 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	38 Participants n=5 Participants	48 Participants n=7 Participants	86 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United Kingdom	47 participants n=5 Participants	50 participants n=7 Participants	97 participants n=5 Participants

PRIMARY outcome

Timeframe: on enrollment

A dysrhythmia will be defined as either 1. Arrhythmia for which there is a Class I or IIa recommendation for treatment with medication or devices in ESC guidelines. 2. One or more of the following even if it does not otherwise meet guideline-indication for treatment: * Sinus bradycardia ≤30bpm for ≥one minute * High-degree atrioventricular (AV) block (3rd degree or Mobitz Type I or II) * Pauses lasting ≥3 seconds (either sinus or AV block) * Frequent ventricular ectopy defined as \>1,000 ectopic beats per day. * Ventricular tachycardia with rate ≥100 bpm for ≥5 beats.

Outcome measures

Outcome measures
Measure	Sinus Rhythm n=47 Participants patients with heart failure and sinus rhythm no intervention	Atrial Fibrillation n=50 Participants patients with heart failure and atrial fibrillation no intervention
Number of Participants With an Identified Dysrhythmia on Baseline ECG Recording	25 Participants	35 Participants

SECONDARY outcome

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

information about new implantations and hospitalisations were known for 46 patients with sinus rhythm (97.9%) and 47 with atrial fibrillation (94%)

Outcome measures

Outcome measures
Measure	Sinus Rhythm n=46 Participants patients with heart failure and sinus rhythm no intervention	Atrial Fibrillation n=47 Participants patients with heart failure and atrial fibrillation no intervention
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 Participants	18 Participants

SECONDARY outcome

Timeframe: 1 year

survival status was known in 46 patients with sinus rhythm (97.9%) and 50 patients with atrial fibrillation (100%)

Outcome measures

Outcome measures
Measure	Sinus Rhythm n=46 Participants patients with heart failure and sinus rhythm no intervention	Atrial Fibrillation n=50 Participants patients with heart failure and atrial fibrillation no intervention
All Cause Mortality	3 Participants	4 Participants

SECONDARY outcome

Timeframe: 1 year

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

information about new implantations were known for 46 patients with sinus rhythm (97.9%) and 47 with atrial fibrillation (94%)

Outcome measures

Outcome measures
Measure	Sinus Rhythm n=46 Participants patients with heart failure and sinus rhythm no intervention	Atrial Fibrillation n=47 Participants patients with heart failure and atrial fibrillation no intervention
Total Number of Patients Implanted With Any Permanent Device Capable of Pacing the Heart	16 Participants	7 Participants

SECONDARY outcome

Timeframe: From date of enrollment until the date of implantation of any permanent device capable of pacing the heart, assessed up to 1 year

information about new implantations were known for 46 patients with sinus rhythm (97.9%) and 47 with atrial fibrillation (94%)

Outcome measures

Outcome measures
Measure	Sinus Rhythm n=46 Participants patients with heart failure and sinus rhythm no intervention	Atrial Fibrillation n=47 Participants patients with heart failure and atrial fibrillation no intervention
Implantation of Any Permanent Device Capable of Pacing the Heart	16 Participants	7 Participants

Adverse Events

Sinus Rhythm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 3 deaths

Atrial Fibrillation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 4 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Yura Mareev

Imperial College

Phone: +79166364410

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place