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
Verified date | October 2023 |
Source | IRCCS Policlinico S. Donato |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Italy | Policlinico San Pietro | Ponte San Pietro | Bergamo |
Italy | Policlinico San Donato | San Donato Milanese | Milan |
Lead Sponsor | Collaborator |
---|---|
IRCCS Policlinico S. Donato |
Italy,
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 |
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