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

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.

Study Overview

• Status: Terminated
• Conditions: Arrhythmia
• Intervention / Treatment: Dietary supplement: ritmonutra; Dietary supplement: placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: riccardo cappato, MD; Phone Number: 00390252774337; Email: riccardo.cappato@grupposandonato.it

Study Locations

• Italy
  • Bergamo
    • Ponte San Pietro, Bergamo, Italy, 24100
      • Policlinico San Pietro
  • Milan
    • San Donato Milanese, Milan, Italy, 20097
      • Policlinico San Donato

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo	Dietary supplement: placebo; sugar pill manufactured to simulated ritmonutra: 2 tablets a day for 4 weeks
Experimental: ritmonutra; ritmonutra 2 tablets/day by mouth for 4 weeks sugar pill manufatured to simulate ritmonutra: 2 tablets/day by mouth for 4 weeks	Dietary supplement: ritmonutra; 2 tablets a day by mouth for 4 weeks; Other Names: ritmonutra rottapharm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: IRCCS Policlinico S. Donato
• Investigators: Principal Investigator: riccardo cappato, MD, Policlinico San Donato

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: March 3, 2014
• First Submitted That Met QC Criteria: March 7, 2014
• First Posted (Estimated): March 14, 2014

Study Record Updates

• Last Update Posted (Estimated): October 9, 2023
• Last Update Submitted That Met QC Criteria: October 6, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: supraventricular ectopic beats
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Heart Diseases; Cardiac Complexes, Premature; Atrial Premature Complexes
• Other Study ID Numbers: RN-tvg-00313b