ArrhythmiaNCT02087033
Use of Ritmonutra in Subjects Affected by Supraventricular Ectopic Beats Without Structural Heart Disease
A study testing ritmonutra in people with Arrhythmia, run by IRCCS Policlinico S. Donato at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Arrhythmia
- What is being tested?
- ritmonutra
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 2 sitesItaly
- Study dates
- Dec 2013to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- acute systemic illness
- preexcitation
- 3 or more consecutive ectopic beats
- vascular disease
- diabetes
- asthma
- soy allergy.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Policlinico San Pietro
Ponte San Pietro, Bergamo, 24100
Policlinico San Donato
San Donato Milanese, Milan, 20097
About this study
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
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.
Read the 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.
- Conditions
- Arrhythmia
- Being tested
- ritmonutra, placebo
- Keywords
- supraventricular ectopic beats
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ritmonutraDietary supplement
Also called ritmonutra rottapharm
2 tablets a day by mouth for 4 weeks
placeboDietary supplement
sugar pill manufactured to simulated ritmonutra: 2 tablets a day for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| ritmonutra | Experimental | ritmonutra 2 tablets/day by mouth for 4 weeks sugar pill manufatured to simulate ritmonutra: 2 tablets/day by mouth for 4 weeks Receives: Dietary Supplement: ritmonutra |
| placebo | Placebo comparator | placebo Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks of treatment
Secondary outcomes (1)
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2014 (estimated)
- Study startDec 2013
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: The study is halted prematurely by sponsoring organization.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArrhythmiaStudies of the same condition, open and under way.
- More trials run by IRCCS Policlinico S. DonatoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Policlinico S. Donato
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- riccardo cappato, MD, Principal investigator, Policlinico San Donato
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02087033
- Sponsor's protocol ID
- RN-tvg-00313b
- Status last verified
- Oct 2023
- First submitted
- 3 Mar 2014
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02087033
- Acronym / sponsor ID
- RN-tvg-00313b
- Conditions
- Arrhythmia
- Keywords
- supraventricular ectopic beats
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study is halted prematurely by sponsoring organization.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- IRCCS Policlinico S. DonatoUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 14 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ritmonutra | Experimental | Dietary Supplement: ritmonutraritmonutra 2 tablets/day by mouth for 4 weeks sugar pill manufatured to simulate ritmonutra: 2 tablets/day by mouth for 4 weeks |
| placebo | Placebo comparator | Dietary Supplement: placeboplacebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- acute systemic illness
- preexcitation
- 3 or more consecutive ectopic beats
- vascular disease
- diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ritmonutraAlso: ritmonutra rottapharm2 tablets a day by mouth for 4 weeks | Dietary supplement | ritmonutra |
| placebosugar pill manufactured to simulated ritmonutra: 2 tablets a day for 4 weeks | Dietary supplement | placebo |
Primary outcome
Efficacy in reduction of supraventricular ectopic beats
Time frame: 4 weeks of treatment
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.
1 secondary outcome
Efficacy in reduction of symptoms related to supraventricular ectopic beats
Time frame: 4 weeks
Results and safety
The study was stopped early (reason given: The study is halted prematurely by sponsoring organization.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
riccardo cappato, MD principal investigator
Policlinico San Donato
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ritmonutra in people with Arrhythmia, run by IRCCS Policlinico S. Donato at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study is halted prematurely by sponsoring organization.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy in reduction of supraventricular ectopic beats (time frame: 4 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023; AzTrials last refreshed its copy on 7 Nov 2026.