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Role of a Combination of Nutraceuticals (Ritmonutra) on Benign Supraventricular and Ventricular Arrhythmias

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01647984
Recruitment Status : Completed
First Posted : July 24, 2012
Last Update Posted : February 3, 2016
Information provided by (Responsible Party):
Bruno Trimarco, Federico II University

Brief Summary:
Study on the role of a combination of nutraceuticals (Ritmonutra) with an effect on benign supraventricular and ventricular extrasystoles in subjects free of a specific organic heart disease. It has been suggested treatment with a nutritional supplement, able to normalize the 'cardiac electrophysiology' and help to maintain wellness. Ritmonutra ® is a combination of nutraceuticals®, including Omega-3 polyunsaturated fatty acids, Hawthorn, Astaxanthin and Vitamin E, help to normalize the heart pacing, reducing the total number of benign extrasystoles and consequently improving the quality of life.

Condition or disease Intervention/treatment Phase
Ventricular and Atrial Extrasytoles Dietary Supplement: Ritmonutra Dietary Supplement: placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Study on the Role of a Combination of Nutraceuticals (Ritmonutra) With an Effect on Benign Supraventricular and Ventricular Arrhythmias in Subjects Free of a Specific Organic Heart Disease.
Study Start Date : December 2012
Actual Primary Completion Date : February 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Placebo
Inert Placebo - Vitamin B complex + diet
Dietary Supplement: placebo
Active Comparator: Ritmonutra
Omega-3 polyunsaturated fatty acids, Hawthorn, Astaxanthin, Vitamin E, Vitamin B complex + diet
Dietary Supplement: Ritmonutra
Ritmonutra ® contains: 720 mg of Fish Oil with Omega-3, including 480 mg of EPA and 40 mg of DHA, Hawthorn (extract from Crataegus mongyna) 300 mg equivalent to 5.4 mg of vitexin, 4 mg of Astaxanthin and 36 mg of Vitamin E
Other Names:
  • Omega-3 polyunsaturated fatty acids
  • Hawthorn
  • Astaxanthin
  • Vitamin E
  • Vitamin B complex
  • Diet

Primary Outcome Measures :
  1. Reduction of the ventricular and atrial arrhythmias. [ Time Frame: 4 week ]

Secondary Outcome Measures :
  1. Improvement in life quality [ Time Frame: 4 week ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Diagnosis of ventricular or atrial extrasystoles

Exclusion Criteria:

  • Presence of organic cardiomyopathy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01647984

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Ambulatorio Ipertensione e Unità Coronarica Federico II University
Naples, Italy, 80131
Sponsors and Collaborators
Federico II University
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Study Director: Bruno Trimarco, MD Federico II University, Dipartimento di medicina Clinica Scienze Cardiovascolari ed Immunologiche
Additional Information:
Publications of Results:
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Responsible Party: Bruno Trimarco, Full Professor of Cardiology, Federico II University Identifier: NCT01647984    
Other Study ID Numbers: RITMONUTRA 2012
First Posted: July 24, 2012    Key Record Dates
Last Update Posted: February 3, 2016
Last Verified: February 2016
Keywords provided by Bruno Trimarco, Federico II University:
Life quality
Additional relevant MeSH terms:
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Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Vitamin E
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Protective Agents