Role of a Combination of Nutraceuticals (Ritmonutra) on Benign Supraventricular and Ventricular Arrhythmias
This study is not yet open for participant recruitment.
Verified July 2012 by Federico II University
Sponsor:
Federico II University
Information provided by (Responsible Party):
Bruno Trimarco, Federico II University
ClinicalTrials.gov Identifier:
NCT01647984
First received: July 12, 2012
Last updated: July 23, 2012
Last verified: July 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Ventricular and Atrial Extrasytoles |
Dietary Supplement: Ritmonutra Dietary Supplement: placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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. |
Resource links provided by NLM:
Drug Information available for:
alpha-Tocopherol
Folic acid
Astaxanthin
Tocopherol
Vitamin E succinate
Tocopherol acetate
dl-alpha-Tocopherol
Vitamin B Complex
Omega-3 Fatty Acids
U.S. FDA Resources
Further study details as provided by Federico II University:
Primary Outcome Measures:
- Reduction of the ventricular and atrial arrhythmias. [ Time Frame: 4 week ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Improvement in life quality [ Time Frame: 4 week ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 1500 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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:
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Diagnosis of ventricular or atrial extrasystoles
Exclusion Criteria:
- Presence of organic cardiomyopathy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01647984
Contacts
| Contact: Bruno Trimarco, MD | +390817462250 | trimarco@unina.it |
| Contact: Raffaele Izzo, MD | +390817462256 | raffaele.izzo@unina.it |
Locations
| Italy | |
| Ambulatorio Ipertensione e Unità Coronarica Federico II University | Recruiting |
| Naples, Italy, 80131 | |
| Contact: Nicola De Luca, MD +390817462220 nicola.deluca@unina.it | |
| Principal Investigator: Bruno Trimarco, MD | |
Sponsors and Collaborators
Federico II University
Investigators
| Study Director: | Bruno Trimarco, MD | Federico II University, Dipartimento di medicina Clinica Scienze Cardiovascolari ed Immunologiche |
More Information
Additional Information:
Publications:
| Responsible Party: | Bruno Trimarco, Full Professor of Cardiology, Federico II University |
| ClinicalTrials.gov Identifier: | NCT01647984 History of Changes |
| Other Study ID Numbers: | RITMONUTRA 2012 |
| Study First Received: | July 12, 2012 |
| Last Updated: | July 23, 2012 |
| Health Authority: | Italy: Ministry of Health Italy: National Bioethics Committee Italy: National Institute of Health Italy: National Monitoring Centre for Clinical Trials - Ministry of Health Italy: The Italian Medicines Agency |
Keywords provided by Federico II University:
|
Arrhythmias Life quality |
Additional relevant MeSH terms:
|
Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes Vitamin B Complex Folic Acid Vitamin E Alpha-Tocopherol Tocopherols Tocotrienols Vitamins |
Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Hematinics Hematologic Agents Therapeutic Uses Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents |
ClinicalTrials.gov processed this record on May 21, 2013