search
Back to results

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

Primary Purpose

Arrhythmia

Status
Terminated
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
ritmonutra
placebo
Sponsored by
IRCCS Policlinico S. Donato
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arrhythmia focused on measuring supraventricular ectopic beats

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Policlinico San Pietro
  • Policlinico San Donato

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ritmonutra

placebo

Arm Description

ritmonutra 2 tablets/day by mouth for 4 weeks sugar pill manufatured to simulate ritmonutra: 2 tablets/day by mouth for 4 weeks

placebo

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
March 3, 2014
Last Updated
October 6, 2023
Sponsor
IRCCS Policlinico S. Donato
search

1. Study Identification

Unique Protocol Identification Number
NCT02087033
Brief Title
Use of Ritmonutra in Subjects Affected by Supraventricular Ectopic Beats Without Structural Heart Disease
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Terminated
Why Stopped
The study is halted prematurely by sponsoring organization.
Study Start Date
December 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IRCCS Policlinico S. Donato

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrhythmia
Keywords
supraventricular ectopic beats

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ritmonutra
Arm Type
Experimental
Arm Description
ritmonutra 2 tablets/day by mouth for 4 weeks sugar pill manufatured to simulate ritmonutra: 2 tablets/day by mouth for 4 weeks
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
ritmonutra
Other Intervention Name(s)
ritmonutra rottapharm
Intervention Description
2 tablets a day by mouth for 4 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo
Intervention Description
sugar pill manufactured to simulated ritmonutra: 2 tablets a day for 4 weeks
Primary Outcome Measure Information:
Title
Efficacy in reduction of supraventricular ectopic beats
Description
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.
Time Frame
4 weeks of treatment
Secondary Outcome Measure Information:
Title
Efficacy in reduction of symptoms related to supraventricular ectopic beats
Description
the secodary outcome will evaluate the reduction of symptoms related to supraventricular ectopic beats using a symptom score and a quality of life questionnaire.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
riccardo cappato, MD
Organizational Affiliation
Policlinico San Donato
Official's Role
Principal Investigator
Facility Information:
Facility Name
Policlinico San Pietro
City
Ponte San Pietro
State/Province
Bergamo
ZIP/Postal Code
24100
Country
Italy
Facility Name
Policlinico San Donato
City
San Donato Milanese
State/Province
Milan
ZIP/Postal Code
20097
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs