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

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02087033

Enrollment

Registered

2014-03-14

Start date

2013-12-31

Completion date

2014-12-31

Last updated

2023-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arrhythmia

Keywords

supraventricular ectopic beats

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.

Interventions

DIETARY_SUPPLEMENTritmonutra

2 tablets a day by mouth for 4 weeks

DIETARY_SUPPLEMENTplacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Efficacy in reduction of supraventricular ectopic beats	4 weeks of treatment	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.

Secondary

Measure	Time frame	Description
Efficacy in reduction of symptoms related to supraventricular ectopic beats	4 weeks	the secodary outcome will evaluate the reduction of symptoms related to supraventricular ectopic beats using a symptom score and a quality of life questionnaire.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026