Adenosine Testing to DEtermine the Need for Pacing Therapy (ADEPT-ILR)

Adenosine Testing to DEtermine the Need for Pacing Therapy With the Additional Use of an Implantable Loop Recorder (ADEPT-ILR Study). The Efficacy of Permanent Pacing in Patients With Syncope and a Positive Intravenous Adenosine Test: a Randomised, Double-blind, Placebo-controlled, Cross-over Trial.

The purpose of this study is to determine whether or not the intravenous adenosine test readily identifies patients with unexplained syncope who would benefit from permanent pacemaker implantation.

Study Overview

• Status: Completed
• Conditions: Syncope
• Intervention / Treatment: Device: Pacemaker implantation (Medtronic); Device: Pacemaker implantation (Medtronic); Device: Implantable Loop Recorder (Medtronic)

Detailed Description

The investigation of syncope (transient loss of consciousness with loss of postural tone, collapse and spontaneous recovery) varies widely, is often lengthy and frequently expensive. The intravenous adenosine test has been used in the investigation of syncope and is cheap, safe and free of serious side effects. However, it is unclear what diagnosis the test unearths. There is some evidence that the test readily identifies bradycardia pacing indications.

In this study we plan to perform the adenosine test and implant a pacemaker should the test be positive. In half of the patients we will turn the pacemaker "on" and in the other half the pacemaker "off". The groups will swap over after six months. During this time we will assess the number of syncopal episodes. Also, in those who have a negative adenosine test we will implant a loop recorder to try to discover the cause of syncope.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Tyne And Wear
    • Newcastle upon Tyne, Tyne And Wear, United Kingdom, NE1 4LP
      • Royal Victoria Infirmary
    • Newcastle upon Tyne, Tyne And Wear, United Kingdom, NE7 7DN
      • Feeeman Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Episode of syncope
• Patient has provided written informed consent for participation in the study prior to any study specific procedures
• Male or female
• Age > 40 years
• No cause of syncope clearly identified on clinical examination, lying and standing blood pressure measurements and standard 12 lead ECG.

Exclusion Criteria:

• Asthma or chronic obstructive pulmonary disease
• Severe coronary disease (myocardial infarction within 3 months, known coronary stenosis >70%, NYHA heart failure or angina symptoms Class III or IV)
• Known severe cerebrovascular disease or known significant internal carotid artery stenosis (>70%)
• Prolonged corrected QT interval
• Unablated accessory pathway
• Pregnancy or lactation
• Use of dipyridamole or any rate-limiting medication that cannot be safely discontinued
• Hypertrophic cardiomyopathy
• Cardiac transplantation
• Concurrent participation in another investigational study or trial
• Inability to give informed consent; carer/proxy assent will be allowed in this study
• Cause of syncope established from initial clinical history and examination, lying and standing blood pressure and ECG

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Pacemaker "on"; DDD+/-R pacing	Device: Pacemaker implantation (Medtronic); DDD+/-R pacing; Other Names: Medtronic DDD+/-R pacemakers; Device: Pacemaker implantation (Medtronic); ODO pacing; Other Names: Medtronic DDR+/-R pacemakers.
PLACEBO_COMPARATOR: Pacemaker "off"; ODO pacing	Device: Pacemaker implantation (Medtronic); DDD+/-R pacing; Other Names: Medtronic DDD+/-R pacemakers; Device: Pacemaker implantation (Medtronic); ODO pacing; Other Names: Medtronic DDR+/-R pacemakers.
EXPERIMENTAL: Implantable Loop Recorder; Implantable loop recorder in adenosine test negative patients	Device: Implantable Loop Recorder (Medtronic); Loop recorder implantation; Other Names: Medtronic Reveal DX or XT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Syncope Burden	Syncope Burden as measured by number of syncopal episodes and recorded by weekly postal patient diaries with telephone reminders to ensure adequate return	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to first syncope	Time to first syncope	12 months
Number of patients with recurrent syncope	Number of patients with >1 episodes of syncope	12 months
Quality of life	Quality of life as measured via the condition-specific instrument the Impact of Syncope on Quality of Life questionnaire with general health-related quality of life measured via the WHOQoL-Brief and WHOQoL-Old instruments	12 months
Health economic analysis	Costs and benefits of the intervention to health and social services. (i) Use of EQ-5D questionnaire to establish the cost per Quality Adjusted Life Year (QALY) (ii) The analysis will include the patients described above as well as a historical comparator group of consecutive patients derived from the database held by the Falls and Syncope Service who have not undergone adenosine testing. This group is particularly important to establish the utility of adenosine testing in the diagnosis of unexplained syncope.	12 months
ECG diagnosis on ILR following syncopal episode in adenosine negative group	ECG diagnosis on ILR following syncopal episode in intravenous adenosine test negative group	12 months

Collaborators and Investigators

• Sponsor: Newcastle-upon-Tyne Hospitals NHS Trust
• Investigators: Principal Investigator: Steve W Parry, PhD, MBBS, MRCP, BSc, Institue of Ageing and Health, University of Newcastle; Principal Investigator: Chris J Pummer, PhD, MRCP, BMBCh, BSc, Newcastle Upon Tyne Hospitals NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 12, 2012
• Primary Completion (ACTUAL): January 26, 2017
• Study Completion (ACTUAL): January 26, 2017

Study Registration Dates

• First Submitted: November 22, 2011
• First Submitted That Met QC Criteria: November 28, 2011
• First Posted (ESTIMATE): November 29, 2011

Study Record Updates

• Last Update Posted (ACTUAL): November 20, 2017
• Last Update Submitted That Met QC Criteria: November 17, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Unconsciousness; Consciousness Disorders; Syncope
• Other Study ID Numbers: 5883; FS/11/13/28690 (OTHER_GRANT: British Heart Foundation)