Use of Ritmonutra in Subjects Affected by Supraventricular Ectopic Beats Without Structural Heart Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized, Double-blinded, Cross-over Study on the Use of Ritmonutra, a Nutraceutical Product Composed of Omega 3 Fatty Acids, Astaxanthin, Vitamin E and Hawthorn in Subjects Affected by Supraventricular Ectopic Beats Without Structural Heart Disease

Conditions
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Arrhythmia

Intervention / Treatment
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* Dietary Supplement: ritmonutra
* Dietary Supplement: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age: 18 to 80 years symptomatic supraventricular ectopic beats (at least 300 in 24 hours recording) no structural heart disease evaluated with ecg, echocardiography, stress test and chest x-ray. no antiarrhythmic drug in use. Exclusion Criteria: acute systemic illness preexcitation 3 or more consecutive ectopic beats vascular disease diabetes asthma soy allergy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ritmonutra<br>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<br>* 2 tablets a day by mouth for 4 weeks<br>* Other names: ritmonutra rottapharm;|
| Placebo Comparator: placebo<br>placebo | Dietary Supplement: placebo<br>* sugar pill manufactured to simulated ritmonutra: 2 tablets a day for 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 4 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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supraventricular ectopic beats