CompletedNot Applicable

Theophylline for Low Adenosine Syncope

Italy77 participantsStarted 2016-05-11

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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 -

What they're measuring

Asystolic syncope

Timeframe: 24 months

Trial details

NCT IDNCT03803215

SponsorCentro Prevenzione Malattie Cardiovascolari N. e V. Corbella

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-11-30

View on ClinicalTrials.gov More Syncope trials