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

San Donato Group (GSD)

Status: Terminated

Conditions: Arrhythmia

Treatments: Dietary Supplement: placebo; Dietary Supplement: ritmonutra

Study type: Interventional

Funder types: Other

Identifiers

NCT02087033

RN-tvg-00313b

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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12 participants in 2 patient groups, including a placebo group

ritmonutra

Experimental group

Description:

ritmonutra 2 tablets/day by mouth for 4 weeks sugar pill manufatured to simulate ritmonutra: 2 tablets/day by mouth for 4 weeks

Treatment:

Dietary Supplement: ritmonutra

placebo

Placebo Comparator group

Description:

placebo

Treatment:

Dietary Supplement: placebo