Arrhythmia Clinical Trial
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
Verified date | October 2023 |
Source | IRCCS Policlinico S. Donato |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 12 |
Est. completion date | December 2014 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - acute systemic illness - preexcitation - 3 or more consecutive ectopic beats - vascular disease - diabetes - asthma - soy allergy. |
Country | Name | City | State |
---|---|---|---|
Italy | Policlinico San Pietro | Ponte San Pietro | Bergamo |
Italy | Policlinico San Donato | San Donato Milanese | Milan |
Lead Sponsor | Collaborator |
---|---|
IRCCS Policlinico S. Donato |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | 4 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05048602 -
Drug-induced Brugada Syndrome Research Database
|
||
Completed |
NCT05053243 -
Clinical Validation of the AliveCor Kardia 12L and 6L Devices
|
N/A | |
Completed |
NCT01913561 -
The Use of Master Caution Garment for Continuous Monitoring for Arrhythmia Detection
|
N/A | |
Completed |
NCT01688648 -
Comparison Between Lidocaine, Dexmedetomidine, and Their Combined Infusion in Subjects Undergoing Coronary Artery Bypass Graft
|
N/A | |
Completed |
NCT01396226 -
A Multi-centre Study Comparing the Effects of AZD2927 and Placebo on the Electrical Activity in the Heart in Patients
|
Phase 2 | |
Terminated |
NCT00624520 -
Mental Stress Reduction in Defibrillator Patients
|
Phase 3 | |
Completed |
NCT00756886 -
Does Atorvastatin Prevent Post Operative Atrial Fibrillation After Pulmonary Resection: A Randomized Clinical Study
|
N/A | |
Terminated |
NCT00721149 -
NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Symptomatic Paroxysmal Atrial Fibrillation- Treatment Use Study
|
Phase 3 | |
Completed |
NCT00510029 -
Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of GAP-134 Administered Intravenously
|
Phase 1 | |
Completed |
NCT00578617 -
Ablation vs Drug Therapy for Atrial Fibrillation - Pilot Trial
|
N/A | |
Active, not recruiting |
NCT00135174 -
Cost-Effectiveness of Routine Follow-up Visits in Patients With a Pacemaker: The Followpace Study
|
N/A | |
Completed |
NCT00119847 -
Electrophysiological Effects of Late PCI After MI
|
N/A | |
Completed |
NCT00023556 -
Genetic Architecture of Heart Disease in Rural Brazil
|
N/A | |
Completed |
NCT00035490 -
Efficacy and Safety Evaluation of Azimilide Dihydrochloride in Patients With Implantable Cardioverter Defibrillators
|
Phase 3 | |
Completed |
NCT01076361 -
Model 4968 CAPTURE EPI® STERIOD-ELUTING BIPOLAR EPICARDIAL PACING LEAD Post-approval Study
|
N/A | |
Completed |
NCT00004560 -
Public Access Defibrillation (PAD) Community Trial
|
Phase 3 | |
Recruiting |
NCT00138931 -
Genetics of Cardiovascular and Neuromuscular Disease
|
||
Completed |
NCT00622453 -
Arrhythmias in Myotonic Muscular Dystrophy
|
N/A | |
Completed |
NCT01076348 -
Model 4965 Post-Approval Study
|
||
Completed |
NCT00000531 -
Antiarrhythmics Versus Implantable Defibrillators (AVID)
|
Phase 3 |