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 range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 -

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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