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

NCT ID: NCT02087033

Last Updated: 2023-10-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2014-12-31

Brief Summary

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

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.

Conditions

Arrhythmia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

ritmonutra

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

Group Type: EXPERIMENTAL

ritmonutra

Intervention Type: DIETARY_SUPPLEMENT

2 tablets a day by mouth for 4 weeks

placebo

placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DIETARY_SUPPLEMENT

sugar pill manufactured to simulated ritmonutra: 2 tablets a day for 4 weeks

Interventions

ritmonutra

2 tablets a day by mouth for 4 weeks

Intervention Type: DIETARY_SUPPLEMENT

placebo

sugar pill manufactured to simulated ritmonutra: 2 tablets a day for 4 weeks

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

ritmonutra rottapharm

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Policlinico S. Donato

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

riccardo cappato, MD

Role: PRINCIPAL_INVESTIGATOR

Policlinico San Donato

Locations

Policlinico San Pietro

Ponte San Pietro, Bergamo, Italy

Policlinico San Donato

San Donato Milanese, Milan, Italy

Countries

Italy

Other Identifiers

RN-tvg-00313b

Identifier Type: -

Identifier Source: org_study_id