Status:
COMPLETED
Theophylline for Low Adenosine Syncope
Lead Sponsor:
Centro Prevenzione Malattie Cardiovascolari N. e V. Corbella
Collaborating Sponsors:
Gruppo Italiano Multidisciplinare per lo Studio della Sincope
Conditions:
Syncope
Eligibility:
All Genders
18+ years
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 con...
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 recu...
Eligibility Criteria
Inclusion
- Male or female gender with age \>18 years
- Unexplained syncope without prodrome or neurally-mediated syncope with atypical prodrome, with normal heart and normal ECG
- Two syncopes /last year or 3 syncopes /last 2 years before start of theophylline treatment
- Having received an ICM according to conventional guideline-based indications
- Being treated with oral theophylline therapy, while been waiting for ICM diagnosis
- Having signed a written informed consent to the study participation and to the treatment of personal data
Exclusion
- Typical vaso-vagal syncope with long prodromes and situational syncope
- Any other form of syncope/T-LOC different from reflex syncope
- Pregnant or breast-feeding patients -
Key Trial Info
Start Date :
May 11 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 30 2020
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT03803215
Start Date
May 11 2016
End Date
December 30 2020
Last Update
January 20 2021
Active Locations (1)
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1
Department of Cardiology, Ospedali del Tigullio
Lavagna, Italy, 16033