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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
12
2 tablets a day by mouth for 4 weeks
sugar pill manufactured to simulated ritmonutra: 2 tablets a day for 4 weeks
Policlinico San Pietro
Ponte San Pietro, Bergamo, Italy
Policlinico San Donato
San Donato Milanese, Milan, Italy
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
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