Study on the Role of a Combination of Nutraceuticals (Ritmonutra) With an Effect on Benign Supraventricular and Ventricular Arrhythmias in Subjects Free of a Specific Organic Heart Disease.

Benign supraventricular and ventricular extrasystoles may frequently occur in subjects free of a specific organic heart disease. use of potent anti-arrhythmic is not indicated for these kind of arrhythmias but the occurrence of this type of extrasystoles may generate concern in patients and consequently worse quality of life.

1. Study Rationale Supraventricular and ventricular extrasystoles may frequently occur in subjects free of a specific organic heart disease. The prognosis of these arrhythmias is benign and the only clinical indication is to perform periodic medical examinations to confirm the absence of an organic heart disease during follow up. Treatment of these benign arrhythmias doesn't required use of potent anti-arrhythmic drugs because of their potential side effects. However, the occurrence of this type of extrasystoles may generate concern in patients despite the assurances of the physician, and consequently worse quality of life. For these reasons it has been suggested treatment with a nutritional supplement, able to normalize the 'cardiac electrophysiology' and help to maintain wellness . Ritmonutra ® is a combination of nutraceuticals with a demonstrated efficacy on preserving the physiological cardiovascular functions in addition to an adequate diet. Ritmonutra ® is classified by the Ministry of Health as a food supplement with Notification in 26 Settmbre 2011. The functional components of Ritmonutra ®, including Omega-3 polyunsaturated fatty acids, Hawthorn, Astaxanthin and Vitamin E, help to normalize the pace, reducing the total number of benign extrasystoles, and consequently improving the quality of life. According to preliminary studies performed in patients with benign extrasystoles, both supraventricular and ventricular, free of specific heart disease, Ritmonutra ® has been demonstrated to have a significant effect in reducing the number of total extrasystoles and in improving the wellness of the subject. In particular, Ritmonutra ® was shown to improve the social life of individuals and reduce the limitations caused by emotional state, without side effects.
2. AIM OF THE STUDY

Aim of the study is to investigate whether addition of Ritmonutra in addition to a adequate diet can improve and normalize the regular rhythm in patients free of specific organic cardiovascular disease compared to a mere placebo. Moreover, in patients with symptomatic benign extrasytoles, the investigators want to evaluate whether this nutraceutical supplement can reduce the discomfort related to perceiving these arrhythmias and consequently improve life quality. 3. STUDY DESIGN multicentre, randomized, controlled parallel-group study. 4. STUDY POPULATION The study will include participation of one clinic centre coordinating 150 general practitioners (GPs). Each GP will select at least 10 subjects of both gender, All participants will give written informed consent to the protocol approved by the local institutional review boards. At least 150 doctors will take part in the study; each will treat at least 10 subjects of both genders with diagnosis of symptomatic benign ventricular and supraventricular extrasytoles, free of specific organic cardiovascular disease and not requiring pharmacological therapy.

Indicators:

GPs are required: 1) to record a full medical history, including smoking and drinking habits, based on a pre-defined clinical record; 2) to collect demographic and anthropometric measures (height, weight, waist circumference at the iliac crest); 3) to perform a complete physical exam. At the first visit and after 4 and 8 weeks all eligible patients will perform a complete physical exam that includes measure of office blood pressure and heart rate in the sitting position and in triplicate, using a manual sphygmomanometer, according to international guidelines. Measurements will be rounded to the closest 2 mmHg interval. The baseline visit and the others screening visits also include Electrocardiogram (ECG), Ergometric test, Echocardiogram and Holter ECG.