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

Primary Purpose

Syncope

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Pacemaker implantation (Medtronic)
Pacemaker implantation (Medtronic)
Implantable Loop Recorder (Medtronic)
Sponsored by
Newcastle-upon-Tyne Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Syncope

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Royal Victoria Infirmary
  • Feeeman Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Experimental

Arm Label

Pacemaker "on"

Pacemaker "off"

Implantable Loop Recorder

Arm Description

DDD+/-R pacing

ODO pacing

Implantable loop recorder in adenosine test negative patients

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Time to first syncope
Time to first syncope
Number of patients with recurrent syncope
Number of patients with >1 episodes of syncope
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
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.
ECG diagnosis on ILR following syncopal episode in adenosine negative group
ECG diagnosis on ILR following syncopal episode in intravenous adenosine test negative group

Full Information

First Posted
November 22, 2011
Last Updated
November 17, 2017
Sponsor
Newcastle-upon-Tyne Hospitals NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT01481168
Brief Title
Adenosine Testing to DEtermine the Need for Pacing Therapy
Acronym
ADEPT-ILR
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
April 12, 2012 (Actual)
Primary Completion Date
January 26, 2017 (Actual)
Study Completion Date
January 26, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Newcastle-upon-Tyne Hospitals NHS Trust

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Syncope

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pacemaker "on"
Arm Type
Active Comparator
Arm Description
DDD+/-R pacing
Arm Title
Pacemaker "off"
Arm Type
Placebo Comparator
Arm Description
ODO pacing
Arm Title
Implantable Loop Recorder
Arm Type
Experimental
Arm Description
Implantable loop recorder in adenosine test negative patients
Intervention Type
Device
Intervention Name(s)
Pacemaker implantation (Medtronic)
Other Intervention Name(s)
Medtronic DDD+/-R pacemakers
Intervention Description
DDD+/-R pacing
Intervention Type
Device
Intervention Name(s)
Pacemaker implantation (Medtronic)
Other Intervention Name(s)
Medtronic DDR+/-R pacemakers.
Intervention Description
ODO pacing
Intervention Type
Device
Intervention Name(s)
Implantable Loop Recorder (Medtronic)
Other Intervention Name(s)
Medtronic Reveal DX or XT
Intervention Description
Loop recorder implantation
Primary Outcome Measure Information:
Title
Syncope Burden
Description
Syncope Burden as measured by number of syncopal episodes and recorded by weekly postal patient diaries with telephone reminders to ensure adequate return
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Time to first syncope
Description
Time to first syncope
Time Frame
12 months
Title
Number of patients with recurrent syncope
Description
Number of patients with >1 episodes of syncope
Time Frame
12 months
Title
Quality of life
Description
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
Time Frame
12 months
Title
Health economic analysis
Description
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.
Time Frame
12 months
Title
ECG diagnosis on ILR following syncopal episode in adenosine negative group
Description
ECG diagnosis on ILR following syncopal episode in intravenous adenosine test negative group
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steve W Parry, PhD, MBBS, MRCP, BSc
Organizational Affiliation
Institue of Ageing and Health, University of Newcastle
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chris J Pummer, PhD, MRCP, BMBCh, BSc
Organizational Affiliation
Newcastle upon Tyne Hospitals NHS FOundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Victoria Infirmary
City
Newcastle upon Tyne
State/Province
Tyne And Wear
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Facility Name
Feeeman Hospital
City
Newcastle upon Tyne
State/Province
Tyne And Wear
ZIP/Postal Code
NE7 7DN
Country
United Kingdom

12. IPD Sharing Statement

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Adenosine Testing to DEtermine the Need for Pacing Therapy

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