Clinical trial NCT01481168: Adenosine Testing to DEtermine the Need for Pacing Therapy
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
Overall status: COMPLETED
Phase: NA
Conditions: Syncope
Lead sponsor: Newcastle-upon-Tyne Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2011-11-29
Enrollment: 52
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Syncope Burden
timeFrame: 12 months
Secondary outcomes:
measure: Time to first syncope
timeFrame: 12 months
measure: Number of patients with recurrent syncope
timeFrame: 12 months
measure: Quality of life
timeFrame: 12 months
measure: Health economic analysis
timeFrame: 12 months
measure: ECG diagnosis on ILR following syncopal episode in adenosine negative group
timeFrame: 12 months
Other outcomes:
Locations:
city: Newcastle upon Tyne
country: United Kingdom
facility: Royal Victoria Infirmary
state: Tyne And Wear
city: Newcastle upon Tyne
country: United Kingdom
facility: Feeeman Hospital
state: Tyne And Wear
Study officials:
affiliation: Institue of Ageing and Health, University of Newcastle
name: Steve W Parry, PhD, MBBS, MRCP, BSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Newcastle upon Tyne Hospitals NHS FOundation Trust
name: Chris J Pummer, PhD, MRCP, BMBCh, BSc
role: PRINCIPAL_INVESTIGATOR
References: