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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Surrey
Sponsor:
Collaborator:
Royal Surrey County Hospital NHS Foundation Trust
Information provided by (Responsible Party):
University of Surrey
ClinicalTrials.gov Identifier:
NCT01867060
First received: May 29, 2013
Last updated: May 20, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Paroxysmal Atrial Fibrillation
Stroke
Device: Automated Cardiac Event Recorder
Device: Personal Heart Rhythm Monitor
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Using a Personal Heart Rhythm Monitor (PHRM) to Diagnose Paroxsymal Atrial Fibrillation (PAF) in the Community - Substudies to Investigate Biomarkers to Detect PAF and to Monitor the Progression of Frequent Atrial Premature Beats to PAF

Resource links provided by NLM:


Further study details as provided by University of Surrey:

Primary Outcome Measures:
  • 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. [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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). [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • The sensitivity and specificity of serum biomarkers to detect cases of PAF. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • The sensitivity and specificity of markers of left atrial function to predict PAF. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • The development of AF in a cohort confirmed to have frequent atrial ectopic beats (APBs) over a one year period. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Adverse events (including stroke/TIA, myocardial infarction, significant bleeding events and death) at six and twelve month intervals. [ Time Frame: 30 months ] [ Designated as safety issue: Yes ]
  • Stroke reduction in the local area [ Time Frame: 30 months ] [ Designated as safety issue: Yes ]
    A reduction in stroke burden in the local area will be calculated from estimated stroke risk in individuals identified with AF and from a local registry.

  • Referrals to secondary care for suspected AF/palpitations [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    The number of referrals to secondary care for suspected PAF will be analysed.

  • Participant satisfaction with the devices used in the study. [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 900
Study Start Date: May 2013
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Personal Heart Rhythm Monitor
Automated Cardiac Event Recorder in parallel with Personal Heart Rhythm Monitor.
Device: Automated Cardiac Event Recorder
Automated Cardiac Event Recorder to be worn continuously for one week.
Other Name: 'R. Test Evolution 4' (Novacor).
Device: Personal Heart Rhythm Monitor
Personal Heart Rhythm Monitor to be used twice-daily for three months.
Other Name: 'Portable ECG monitor HCG-801' (OMRON Healthcare).

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

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01867060

Contacts
Contact: Philippa J Howlett, MBChB BSc philippah@doctors.org.uk
Contact: Edward W Leatham, MBChB MD eleatham@hasteacademy.org

Locations
United Kingdom
Royal Surrey County Hospital NHS Foundation Trust Recruiting
Guildford, Surrey, United Kingdom, GU2 7XX
Contact: Philippa J Howlett, MBChB BSc MRCP       philippah@doctors.org.uk   
Principal Investigator: Edward W Leatham, MBChB MD         
Sub-Investigator: Philippa J Howlett, MBChB BSc         
Sponsors and Collaborators
University of Surrey
Royal Surrey County Hospital NHS Foundation Trust
Investigators
Principal Investigator: Philippa Howlett, MBChB BSc The Royal Surrey County Hospital
Study Director: Edward Leatham, MBChB MD The Royal Surrey County Hospital
Study Director: Chris Fry, BSc PhD The University of Surrey
  More Information

Additional Information:
No publications provided

Responsible Party: University of Surrey
ClinicalTrials.gov Identifier: NCT01867060     History of Changes
Other Study ID Numbers: HASTE-2
Study First Received: May 29, 2013
Last Updated: May 20, 2014
Health Authority: United Kingdom: National Health Service

Keywords provided by University of Surrey:
Cardiac monitoring
Biomarkers
Transthoracic echocardiography

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 19, 2014