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:
IRCCS Policlinico S. Donato
Organization:
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study is halted prematurely by sponsoring organization.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: