Dietary Supplement on Symptom Awareness and Heart Rhythm in Patients With Cardiac Arrhythmia

Study Overview
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Brief Summary
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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.

Official Title
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Influence of a Specific Micronutrient Combination on Symptom Awareness and Heart Rhythm in Patients With Cardiac Arrhythmia

Conditions
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Cardiac Arrhythmia

Intervention / Treatment
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* Dietary Supplement: MNC-01
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: PVB in the long-term ECG recording (registration at least 18 hours): at least 500 PVB/24 h or Supraventricular tachycardia (≥10 episodes/24h, outside sporting activity) or SVPB with vegetative symptoms (increased sweating, inner unrest, shaky hands, red dermographism) and no cardial pretreatment Exclusion Criteria: Left ventricular ejection fraction [EF] ≤ 40 % Therapy with spironolactone > 50 mg/d Therapy with torasemide > 20 mg/d Supplementation or therapy with dietary supplements or drugs which contain vitamins and minerals (above all potassium and magnesium) Creatinine in the serum [i. S.]:≥ 1,4 mg/dl (men), ≥ 1,2 mg/dl (women) Potassium i. S. ≤ 3,4 mmol/l and > 5,4 mmol/l Magnesium i. S. ≤ 0,7 mmol/l and > 1,0 mmol/l Acute and chronic diarrhea Hyperthyroidism anamnestic or due to the current TSH (thyroid stimulating hormone)-value Pacemaker

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MNC-01<br>potassium, magnesium, and vitamins (MNC-01) | Dietary Supplement: MNC-01<br>* twice daily 2 tablets with appr. 200 ml still water or tap water; duration: 6 weeks<br>|
| Placebo Comparator: Placebo<br>cellulose, microcrystalline [NF], HPMC E15, | Dietary Supplement: Placebo<br>* twice daily 2 tablets with appr. 200 ml still water or tap water; duration: 6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heart rhythm disturbances and symptoms, dietary supplement