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

This study is currently recruiting participants.
Verified July 2013 by Federico II University
Sponsor:
Information provided by (Responsible Party):
Bruno Trimarco, Federico II University
ClinicalTrials.gov Identifier:
NCT01647984
First received: July 12, 2012
Last updated: July 10, 2013
Last verified: July 2013
  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:


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: December 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:
  • Omega-3 polyunsaturated fatty acids
  • Hawthorn
  • Astaxanthin
  • Vitamin E
  • Vitamin B complex
  • Diet

  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 10, 2013
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 April 16, 2014