Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01647984 |
| Other study ID # |
RITMONUTRA 2012 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 4
|
| First received |
July 12, 2012 |
| Last updated |
February 2, 2016 |
| Start date |
December 2012 |
| Est. completion date |
December 2014 |
Study information
| Verified date |
February 2016 |
| Source |
Federico II University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Italy: Ministry of HealthItaly: National Bioethics CommitteeItaly: National Institute of HealthItaly: National Monitoring Centre for Clinical Trials - Ministry of HealthItaly: The Italian Medicines Agency |
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
Benign supraventricular and ventricular extrasystoles may frequently occur in subjects free
of a specific organic heart disease. use of potent anti-arrhythmic is not indicated for
these kind of arrhythmias but the occurrence of this type of extrasystoles may generate
concern in patients and consequently worse quality of life.
1. Study Rationale Supraventricular and ventricular extrasystoles may frequently occur in
subjects free of a specific organic heart disease. The prognosis of these arrhythmias
is benign and the only clinical indication is to perform periodic medical examinations
to confirm the absence of an organic heart disease during follow up. Treatment of these
benign arrhythmias doesn't required use of potent anti-arrhythmic drugs because of
their potential side effects. However, the occurrence of this type of extrasystoles may
generate concern in patients despite the assurances of the physician, and consequently
worse quality of life. For these reasons 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 with a demonstrated
efficacy on preserving the physiological cardiovascular functions in addition to an
adequate diet. Ritmonutra ® is classified by the Ministry of Health as a food
supplement with Notification in 26 Settmbre 2011. The functional components of
Ritmonutra ®, including Omega-3 polyunsaturated fatty acids, Hawthorn, Astaxanthin and
Vitamin E, help to normalize the pace, reducing the total number of benign
extrasystoles, and consequently improving the quality of life. According to preliminary
studies performed in patients with benign extrasystoles, both supraventricular and
ventricular, free of specific heart disease, Ritmonutra ® has been demonstrated to have
a significant effect in reducing the number of total extrasystoles and in improving the
wellness of the subject. In particular, Ritmonutra ® was shown to improve the social
life of individuals and reduce the limitations caused by emotional state, without side
effects.
2. AIM OF THE STUDY
Aim of the study is to investigate whether addition of Ritmonutra in addition to a
adequate diet can improve and normalize the regular rhythm in patients free of specific
organic cardiovascular disease compared to a mere placebo. Moreover, in patients with
symptomatic benign extrasytoles, the investigators want to evaluate whether this
nutraceutical supplement can reduce the discomfort related to perceiving these
arrhythmias and consequently improve life quality.
3. STUDY DESIGN multicentre, randomized, controlled parallel-group study.
4. STUDY POPULATION The study will include participation of one clinic centre coordinating
150 general practitioners (GPs). Each GP will select at least 10 subjects of both
gender, All participants will give written informed consent to the protocol approved by
the local institutional review boards. At least 150 doctors will take part in the
study; each will treat at least 10 subjects of both genders with diagnosis of
symptomatic benign ventricular and supraventricular extrasytoles, free of specific
organic cardiovascular disease and not requiring pharmacological therapy.
Indicators:
GPs are required: 1) to record a full medical history, including smoking and drinking
habits, based on a pre-defined clinical record; 2) to collect demographic and
anthropometric measures (height, weight, waist circumference at the iliac crest); 3) to
perform a complete physical exam. At the first visit and after 4 and 8 weeks all
eligible patients will perform a complete physical exam that includes measure of office
blood pressure and heart rate in the sitting position and in triplicate, using a manual
sphygmomanometer, according to international guidelines. Measurements will be rounded
to the closest 2 mmHg interval. The baseline visit and the others screening visits also
include Electrocardiogram (ECG), Ergometric test, Echocardiogram and Holter ECG.
The primary endpoint is reduction of total number of extrasystoles. Secondary endpoint:
the improvement in the wellness of the subject and consequently in the life quality.
4.1. Sample size The estimate of the sample size was performed by the SISA method
(Simple Interactive Statistical Analysis) - Machin, David and Campbell, Michael J.
(1987) Statistical Tables for the Design of Clinical Trials. Blackwell Scientific
Publications, Boston. Based on the values of a previous preliminary study comparing
Ritmonutra ® with a control group (-58.5% reduction of total extrasystoles after 4
weeks with Ritmonutra ® compared with-0.5% in the control group) an approximate
estimate was made of the number of observations necessary so that the two percentages
are significant at the 5% probability level: 12 subjects cases in each group.
5. TREATMENTS
All subjects will receive dietary counseling determined by the general practitioner
depending on the subject's clinical condition, in accordance with the instructions of
the Coordinating Site. Centralized randomization will be used to assign subjects to one
of the two study treatments, Inert Placebo - Vitamin B complex + diet or vitamin B
complex - Ritmonutra ® + diet. How Ritmonutra will be taken: 2 tavgel gum daily of
Ritmonutra ® or vitamin B complex 2 tablets chewing a day.
Duration of treatment: Subjects in both groups will take the assigned treatment for 4
weeks. 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.
6. EVALUATION CRITERIA At baseline, and after 4 and 8 weeks cardiovascular parameters
(blood pressure, heart rate, Holter ECG) and the SF-36 quality of life questionnaire
and the 4SQ_2011questionnaire investigating somatic symptoms related to stress will be
assessed as well as the others clinical parameters necessary to evaluate the
cardiovascular risk and changes in life quality.
7. STUDY PROCEDURES Each doctor will initially be given a login and password allowing
confidential and individual access to the website www.ritmonutra.net for data entry. In
order to avoid sampling errors, the doctor will include in the study the first 10
consecutive subjects who meet the admission criteria (see point 4). The doctor will
complete the appropriate form (also available on the ritmonutra.net site) insert
information of the point 0 and will assign the subject to one of two regimens, Inert
Placebo - Vitamin B complex + diet or vitamin B complex - Ritmonutra ® + diet, based on
what has been determined by centralized randomization under the responsibility of Prof.
Bruno Trimarco and delivery to the subject the treatment required for 4 weeks
(Ritmonutra ® or control). After four weeks all the subjects under go to Holter ECG,
the SF-36 and 4SQ_2011. After the first four weeks patients will receive the
alternative treatment provided by randomization (control - Ritmonutra ®). After another
four weeks all the subjects underwent 24-Hour Holter (ECG) monitoring , the SF-36 and
4SQ_2011.
8. STATISTICAL ANALYSIS The statistical analysis of baseline homogeneity will be
undertaken using the chi-square test and analysis of variance, if appropriate.
The statistical analysis to assess the clinical efficacy will be based on a comparison
between differences at the various time points versus the baseline obtained in the two
treatment groups and will be conducted using the chi-square test and analysis of
variance, where appropriate.
The level of significance will be considered to be an Alfa = 0.05 (type I error) and
the power level a beta = 0.90 (type II error).
9. STUDY TIMELINES The study will start from the time the login and password have been
delivered.
10. AVAILABILITY OF DATA All participants will be informed of the results once the data
have been processed.
11. COORDINATING COMMITTEE
For any clarification on the study contact:
Dr. Claudio Benvenuti - Medical Management Rottapharm | Madaus Valosa via di Sopra, 9-20900
Monza tel 039 7390406 - Fax 039 7390393 email: @ claudio.benvenuti rottapharm.com.
