Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2026-02-26 @ 4:18 PM
Study NCT ID:
NCT02087033
Status:
TERMINATED
Last Update Posted:
2023-10-10
First Post:
2014-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Ritmonutra in Subjects Affected by Supraventricular Ectopic Beats Without Structural Heart Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'whyStopped': 'The study is halted prematurely by sponsoring organization.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-06', 'studyFirstSubmitDate': '2014-03-03', 'studyFirstSubmitQcDate': '2014-03-07', 'lastUpdatePostDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-03-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy in reduction of supraventricular ectopic beats', 'timeFrame': '4 weeks of treatment', '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.'}], 'secondaryOutcomes': [{'measure': 'Efficacy in reduction of symptoms related to supraventricular ectopic beats', 'timeFrame': '4 weeks', '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['supraventricular ectopic beats'], 'conditions': ['Arrhythmia']}, 'descriptionModule': {'briefSummary': '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.\n\nThe study will evaluate the reduction of the number of supraventricular ectopic beats and symptoms related.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age: 18 to 80 years\n* symptomatic supraventricular ectopic beats (at least 300 in 24 hours recording)\n* no structural heart disease evaluated with ecg, echocardiography, stress test and chest x-ray.\n* no antiarrhythmic drug in use.\n\nExclusion Criteria:\n\n* acute systemic illness\n* preexcitation\n* 3 or more consecutive ectopic beats\n* vascular disease\n* diabetes\n* asthma\n* soy allergy.'}, 'identificationModule': {'nctId': 'NCT02087033', 'briefTitle': 'Use of Ritmonutra in Subjects Affected by Supraventricular Ectopic Beats Without Structural Heart Disease', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Policlinico S. Donato'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'RN-tvg-00313b'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ritmonutra', 'description': 'ritmonutra 2 tablets/day by mouth for 4 weeks sugar pill manufatured to simulate ritmonutra: 2 tablets/day by mouth for 4 weeks', 'interventionNames': ['Dietary Supplement: ritmonutra']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'placebo', 'interventionNames': ['Dietary Supplement: placebo']}], 'interventions': [{'name': 'ritmonutra', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['ritmonutra rottapharm'], 'description': '2 tablets a day by mouth for 4 weeks', 'armGroupLabels': ['ritmonutra']}, {'name': 'placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'sugar pill manufactured to simulated ritmonutra: 2 tablets a day for 4 weeks', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '24100', 'city': 'Ponte San Pietro', 'state': 'Bergamo', 'country': 'Italy', 'facility': 'Policlinico San Pietro', 'geoPoint': {'lat': 45.70596, 'lon': 9.5905}}, {'zip': '20097', 'city': 'San Donato Milanese', 'state': 'Milan', 'country': 'Italy', 'facility': 'Policlinico San Donato', 'geoPoint': {'lat': 45.41047, 'lon': 9.26838}}], 'overallOfficials': [{'name': 'riccardo cappato, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Policlinico San Donato'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Policlinico S. Donato', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}