A Phase 3 interventional study of MNC-01 and Placebo in Cardiac Arrhythmia, sponsored by Trommsdorff GmbH & Co. KG. Completed at 1 site in Germany. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-01-11.
Sponsored by Trommsdorff GmbH & Co. KG · Phase 3, Interventional, and Treatment
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.
885 studies on the registry are indexed under Arrhythmias, Cardiac; 235 are open to participants now.
This study's enrollment of 74 is below the median of 99 across 429 interventional studies indexed under Arrhythmias, Cardiac.
Browse Arrhythmias, Cardiac studies →This is the only study on the registry with Trommsdorff GmbH & Co. KG as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
potassium, magnesium, and vitamins (MNC-01)
Dietary Supplement: MNC-01
cellulose, microcrystalline \[NF\], HPMC E15,
Dietary Supplement: Placebo
twice daily 2 tablets with appr. 200 ml still water or tap water; duration: 6 weeks
twice daily 2 tablets with appr. 200 ml still water or tap water; duration: 6 weeks
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
Time frame: end week 3 and week 6
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%
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: end week 3 and week 6
This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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