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

Arrhythmia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02087033
• Other study ID #: RN-tvg-00313b
• Status: Terminated
• Phase: N/A
• Start date: December 2013
• Est. completion date: December 2014

Study information

• Verified date: October 2023
• Source: IRCCS Policlinico S. Donato
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arrhythmia
• Atrial Premature Complexes
• Heart Diseases

Intervention

Dietary Supplement:
• ritmonutra
2 tablets a day by mouth for 4 weeks
• placebo
sugar pill manufactured to simulated ritmonutra: 2 tablets a day for 4 weeks

Locations

Country	Name	City	State
Italy	Policlinico San Pietro	Ponte San Pietro	Bergamo
Italy	Policlinico San Donato	San Donato Milanese	Milan

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Policlinico S. Donato

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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