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| Name | Class |
|---|---|
| Bonn Education Association for Dietetics r.A., Cologne, Germany | INDUSTRY |
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The main aim of this study, which was carried out in two parallel groups, is testing the efficacy of a specific micronutrients combination in adults with heart rhythm disturbances and accompanying symptoms.
It is therefore the investigators hypothesis that daily oral administration of the specific micronutrients combination will lead to a decrease of symptoms awareness and to a reduction of heart rhythm disturbances in adults with or without structural heart disease. The principal endpoints will be a decrease in the total score of symptoms awareness.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MNC-01 | Active Comparator | potassium, magnesium, and vitamins (MNC-01) |
|
| Placebo | Placebo Comparator | cellulose, microcrystalline [NF], HPMC E15, |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MNC-01 | Dietary Supplement | twice daily 2 tablets with appr. 200 ml still water or tap water; duration: 6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the changes in the perception of six symptoms | at baseline, at follow-up visit 4 (at the end of week three) and at follow-up visit 5 (at the end of study) by visual analogue scale [VAS]: complete summary to a total score value in comparison to baseline | end week 3 and week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| symptom awareness and responder rate | the responder rates of the changes, measured by the amount of patients with a reduction of the total score value at follow-up visit 5 (at the end of study) in comparison to baseline of at least 20% | end week 6 |
| symptom awareness and changes during the study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christine Metzner, Prof. MD | Bonn Education Association for Dietetics r. A. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Elke Parsi assoc. Prof. MD | Berlin | State of Berlin | 13053 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30509185 | Derived | Parsi E, Bitterlich N, Winkelmann A, Rosler D, Metzner C. Dietary intervention with a specific micronutrient combination for the treatment of patients with cardiac arrhythmias: the impact on insulin resistance and left ventricular function. BMC Cardiovasc Disord. 2018 Dec 3;18(1):220. doi: 10.1186/s12872-018-0954-6. |
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| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Placebo | Dietary Supplement | twice daily 2 tablets with appr. 200 ml still water or tap water; duration: 6 weeks |
|
evaluation of the changes in the awareness of six symptoms, namely: irregular heartbeat, palpitations, heart stumbling, sweating, dyspnea, and anxiety or panic attacks at baseline, at follow-up visit 4 (at the end of week three) and at the end of week six by VAS and summary to a total score value |
| end week 3 and week 6 |
| absolute reduction in premature ventricular beat (PVB) | the absolute reduction of the PVB in 24 hours at follow-up visit 4 (at the end of week three) and follow-up visit 5 (at the end of study) in comparison to baseline | end week 3 and 6 week |
| relative reduction of the premature ventricular beat (PVB) | the relative reduction of the PVB in 24 hours at follow-up visit 4 (at the end of week three) and follow-up visit 5 (at the end of study) in comparison to baseline | end week 3 and week 6 |
| responder rate of the premature ventricular beat (PVB) | the responder rate measured by the amount of patients with a reduction of the PVB of at least 5 % at the end of study | end week 3 and week 6 |
| absolute reduction of supraventricular premature beats (SVPB) | the absolute reduction of the SVPB in 24 hours in combination with a reduction of the awareness of the six symptoms | end week 3 and week 6 |
| relative reduction of supraventricular premature beats (SVPB) | the relative reduction of the SVPB in 24 hours in combination with a reduction of the awareness of the six symptoms | end week 3 and week 6 |
| responder rate | the responder rate, measured by the amount of patients with a reduction of the PVB of at least 5 % at the end of study | end week 3 and week 6 |