Cardiac Arrhythmia
Conditions
Keywords
heart rhythm disturbances and symptoms, dietary supplement
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTMNC-01
twice daily 2 tablets with appr. 200 ml still water or tap water; duration: 6 weeks
DIETARY_SUPPLEMENTPlacebo
twice daily 2 tablets with appr. 200 ml still water or tap water; duration: 6 weeks
Sponsors
Bonn Education Association for Dietetics r.A., Cologne, Germany
Trommsdorff GmbH & Co. KG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the changes in the perception of six symptoms | end week 3 and week 6 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| symptom awareness and changes during the study | end week 3 and week 6 | 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 |
| absolute reduction in premature ventricular beat (PVB) | end week 3 and 6 week | 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 |
| relative reduction of the premature ventricular beat (PVB) | end week 3 and week 6 | 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 |
| symptom awareness and responder rate | end week 6 | 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% |
| absolute reduction of supraventricular premature beats (SVPB) | end week 3 and week 6 | the absolute reduction of the SVPB in 24 hours in combination with a reduction of the awareness of the six symptoms |
| relative reduction of supraventricular premature beats (SVPB) | end week 3 and week 6 | the relative reduction of the SVPB in 24 hours in combination with a reduction of the awareness of the six symptoms |
| responder rate | end week 3 and week 6 | the responder rate, measured by the amount of patients with a reduction of the PVB of at least 5 % at the end of study |
| responder rate of the premature ventricular beat (PVB) | end week 3 and week 6 | the responder rate measured by the amount of patients with a reduction of the PVB of at least 5 % at the end of study |
Countries
Germany
Outcome results
None listed