An interventional study of ritmonutra and placebo in Arrhythmia, sponsored by IRCCS Policlinico S. Donato. Terminated at 2 sites in Italy. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-10-10.
Sponsored by IRCCS Policlinico S. Donato · Not applicable, Interventional, and Treatment
it is a prospective, randomized, double-blinded, crossover study on the use of an association of omega 3 fatty acids, astaxanthin, vitamin E and hawthorn (ritmonutra) in subject affected by symptomatic supraventricular ectopic beats without structural heart disease.
The study will evaluate the reduction of the number of supraventricular ectopic beats and symptoms related.
24 subjects without structural heart disease with a minimum of 300 supraventricular ectopic beats in 24 hours will be enrolled in the two participating centers and randomized to the treatment or to the placebo for 4 weeks. At the end of the first treatment period, a 24 hours Holter ECG will be performed. After 1 week of wash-out therapy, subjects will be crossed over to the other treatment for 4 weeks. Another 24 hours Holter ECG will be performed at the end of the study. During the baseline visit and during each follow up visit, symptom score and quality of life questionnaires will be completed by the subjects.
915 studies on the registry are indexed under Arrhythmias, Cardiac; 234 are open to participants now.
This study's enrollment of 12 is below the median of 97 across 443 interventional studies indexed under Arrhythmias, Cardiac.
Browse Arrhythmias, Cardiac studies →IRCCS Policlinico S. Donato is the lead sponsor of 103 studies on the registry; 51 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
ritmonutra 2 tablets/day by mouth for 4 weeks sugar pill manufatured to simulate ritmonutra: 2 tablets/day by mouth for 4 weeks
Dietary Supplement: ritmonutra
placebo
Dietary Supplement: placebo
2 tablets a day by mouth for 4 weeks
Also known as: ritmonutra rottapharm
sugar pill manufactured to simulated ritmonutra: 2 tablets a day for 4 weeks
Efficacy in reduction of supraventricular ectopic beats
the primary outcome will evaluate the reduction of the number of supraventricular ectopic beats after 4 weeks of treatment using a 24 h holter recording.
Time frame: 4 weeks of treatment
Efficacy in reduction of symptoms related to supraventricular ectopic beats
the secodary outcome will evaluate the reduction of symptoms related to supraventricular ectopic beats using a symptom score and a quality of life questionnaire.
Time frame: 4 weeks
This study is terminated, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.