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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

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 Summary: 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.
Sponsor: IRCCS Policlinico S. Donato

Current Primary Outcome: Efficacy in reduction of supraventricular ectopic beats [ Time Frame: 4 weeks of treatment ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Efficacy in reduction of symptoms related to supraventricular ectopic beats [ Time Frame: 4 weeks ]

Original Secondary Outcome: Same as current

Information By: IRCCS Policlinico S. Donato

Dates:
Date Received: March 3, 2014
Date Started: December 2013
Date Completion:
Last Updated: March 7, 2014
Last Verified: February 2014