Ignite Creation Date:
2024-05-06 @ 12:37 PM
Last Modification Date:
2024-10-26 @ 1:01 PM
Study NCT ID:
NCT03803215
Status:
COMPLETED
Last Update Posted:
2021-01-20
First Post:
2019-01-10
Brief Title:
Theophylline for Low Adenosine Syncope
Sponsor:
Centro Prevenzione Malattie Cardiovascolari N e V Corbella
Organization:
Centro Prevenzione Malattie Cardiovascolari N e V Corbella
Study Overview
Official Title:
Theophylline in Patients With Unexplained Syncope and Low Adenosine Study Verified by ICM Controlled by Propensity-score Matching
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
THEO-USA
Brief Summary:
The study aims at assessing that theophylline is effective in patients with no prodromes normal heart and with low values of plasmatic adenosine compared with a propensity-score matched untreated control population who have received an implantable cardiac monitor ICM for diagnosis of unexplained or atypical reflex syncope
Detailed Description:
Theophylline has been used for 3 decades in ordinary medical practice to tentatively prevent syncopal recurrences in patients affected by neurally-mediated syncope Observational studies report a recurrence rate with this drug ranging between 12 and 22 Theophylline was much more effective in selected patients with syncope without prodromes and normal heart who had ECG documentation of long pauses at the time of syncopal attack and low values of baseline plasmatic adenosine Since theophylline is a non-selective antagonist of purinergic receptors it has been hypothesized that purinergic receptors are involved in the mechanism of syncope in such patients Conversely theophylline was suspected to be ineffective or less effective in patients affected by other forms of neurally-mediated syncope
The present study aims at assessing that theophylline is effective in patients with no prodromes normal heart and with low values of plasmatic adenosine compared with a propensity-score matched untreated control population
This will be a multicenter non interventional study verified by ICM with 2 predefined subgroups
Subgroup 1
Low adenosine group Patients with Low Adenosine values 040 μmolL
Normalhigh adenosine 040 μmolL group any other patient Subgroup 2
Patients with no prodromes or very short prodromes 5 sec normal heart and normal ECG No prodrome group
Any other form of atypical neurally-mediated syncope with prodromes 5 sec Remote or in-hospital periodic follow-up will be done according to centres clinical practice for ICM monitoring
Patients will be followed up until the first primary endpoint event with a maximum follow-up of 24 months since start of theophylline treatment
The present study aims at assessing that theophylline is effective in patients with no prodromes normal heart and with low values of plasmatic adenosine compared with a propensity-score matched untreated control population
This will be a multicenter non interventional study verified by ICM with 2 predefined subgroups
Subgroup 1
Low adenosine group Patients with Low Adenosine values 040 μmolL
Normalhigh adenosine 040 μmolL group any other patient Subgroup 2
Patients with no prodromes or very short prodromes 5 sec normal heart and normal ECG No prodrome group
Any other form of atypical neurally-mediated syncope with prodromes 5 sec Remote or in-hospital periodic follow-up will be done according to centres clinical practice for ICM monitoring
Patients will be followed up until the first primary endpoint event with a maximum follow-up of 24 months since start of theophylline treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None