Clinical trial NCT01867060: Using a Personal Heart Rhythm Monitor to Diagnose Paroxsymal Atrial Fibrillation in the Community
Official title: Using a Personal Heart Rhythm Monitor (PHRM) to Diagnose Paroxsymal Atrial Fibrillation (PAF) in the Community; and the PREDICT-PAF Substudy - an Investigation of Biomarkers to Detect PAF.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Paroxysmal Atrial Fibrillation
Stroke
Keywords: Cardiac monitoring
Biomarkers
Transthoracic echocardiography
Lead sponsor: University of Surrey
Sponsor class: OTHER
Collaborators: name: Royal Surrey County Hospital NHS Foundation Trust
First posted: 2013-06-03
Enrollment: 194
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This propsective study aims to compare the diagnostic yield of a Personal Heart Rhythm Monitor (PHRM) with an automated cardiac event recorder (ACER) to detect paroxysmal Atrial Fibrillation PAF). The investigators hypothesise that the PHRM, used intermittently for 3 months, will detect significantly more cases of PAF than the ACER, used continuously for one week.

A case-control sub-study will identify individuals with confirmed PAF, and matched individuals with no evidence of PAF, to identify potential serum biomarkers for PAF.

A further case-control study will assess markers of left atrial function in patients with PAF and their matched controls.

Another case-control sub-study will determine the significance of frequent Atrial Premature Beats (APBs) in the development of AF over a one year period.

Detailed description: Patients with suspected AF will be initially referred to a community-based, nurse-led Arrhythmia clinic by their General Practitioners over a 15-month period.

All patients will be issued with a one week ACER (the 'R. Test 4 Evolution'), seen as the 'best-practice' investigation for this population group. Participants will also be issued with a PHRM for three months. They will be instructed to take regular twice-daily, 30 second recordings with additional recordings in the event of relevant symptoms. They will return the ACER after one week and the PHRM after 3 months.

A subgroup of participants (target recruitment number = 100) will undergo transthoracic echocardiography. A 40ml venous blood sample will also be taken. Another small subgroup (target recruitment = 20) will be asked to continue twice-daily recordings using the PHRM for a further nine months and will be issued with a repeat one week ACER at study completion.

Eligibility criteria: Inclusion Criteria:

* Suspected paroxysmal AF (either palpitations consistent with AF or an irregular pulse)
* 12-lead resting ECG confirming sinus rhythm
* Capacity to consent to study
* English-speaking
* Life expectancy at least one year

Exclusion Criteria:

* Previous diagnosis of AF
* Recent history of syncope
* Recent history of cardiac-sounding chest pain
* A resting ECG suggestive of alternative arrhythmia
* Inability to use the telephone
* Thyrotoxicosis

Primary outcomes:
measure: The diagnostic yield of a Personal Heart Rhythm Monitor (PHRM), used for 3 months, compared to an automated cardiac event recorder (ACER), used for 1 week, to detect all episodes of paroxysmal atrial fibrillation.
timeFrame: 18 months
Secondary outcomes:
measure: The diagnostic yield of a Personal Heart Rhythm Monitor (PHRM), used for 3 months, compared to an automated cardiac event recorder (ACER), used for 1 week, to detect prolonged episodes of paroxysmal atrial fibrillation (defined as greater than 12 hours).
timeFrame: 18 months
measure: The sensitivity and specificity of serum biomarkers to detect cases of PAF.
timeFrame: 18 months
measure: The sensitivity and specificity of markers of left atrial function to predict PAF.
timeFrame: 18 months
measure: The development of AF in a cohort confirmed to have frequent atrial ectopic beats (APBs) over a one year period.
timeFrame: 18 months
measure: Adverse events (including stroke/TIA, myocardial infarction, significant bleeding events and death) at six and twelve month intervals.
timeFrame: 30 months
measure: Stroke reduction in the local area
timeFrame: 30 months
measure: Referrals to secondary care for suspected AF/palpitations
timeFrame: 18 months
measure: Participant satisfaction with the devices used in the study.
timeFrame: 18 months
Other outcomes:
Locations:
city: Guildford
country: United Kingdom
facility: Royal Surrey County Hospital NHS Foundation Trust
state: Surrey
Study officials:
affiliation: The Royal Surrey County Hospital
name: Philippa Howlett, MBChB BSc
role: PRINCIPAL_INVESTIGATOR
affiliation: The Royal Surrey County Hospital
name: Edward Leatham, MBChB MD
role: STUDY_DIRECTOR
affiliation: The University of Surrey
name: Chris Fry, BSc PhD
role: STUDY_DIRECTOR
References: