Study Stopped
The study is halted prematurely by sponsoring organization.
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
1 other identifier
interventional
12
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2013
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 3, 2014
CompletedFirst Posted
Study publicly available on registry
March 14, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedOctober 10, 2023
October 1, 2023
1 year
March 3, 2014
October 6, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Efficacy in reduction of symptoms related to supraventricular ectopic beats
4 weeks
Study Arms (2)
ritmonutra
EXPERIMENTALritmonutra 2 tablets/day by mouth for 4 weeks sugar pill manufatured to simulate ritmonutra: 2 tablets/day by mouth for 4 weeks
placebo
PLACEBO COMPARATORplacebo
Interventions
2 tablets a day by mouth for 4 weeks
sugar pill manufactured to simulated ritmonutra: 2 tablets a day for 4 weeks
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- acute systemic illness
- preexcitation
- or more consecutive ectopic beats
- vascular disease
- diabetes
- asthma
- soy allergy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Policlinico San Pietro
Ponte San Pietro, Bergamo, 24100, Italy
Policlinico San Donato
San Donato Milanese, Milan, 20097, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
riccardo cappato, MD
Policlinico San Donato
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 3, 2014
First Posted
March 14, 2014
Study Start
December 1, 2013
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
October 10, 2023
Record last verified: 2023-10