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

Phase 3

Completed

• Conditions: Cardiac Arrhythmia
• Interventions: Dietary Supplement: MNC-01; Dietary Supplement: Placebo

• Registration Number: NCT02652338
• Lead Sponsor: Trommsdorff GmbH & Co. KG

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Study First Submitted: 2015-12-16
• Status Verified: 2016-01
• Study First Submitted QC: 2016-01-07
• Last Update Submitted: 2016-01-07
• Study First Posted: 2016-01-11
• Last Update Posted: 2016-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MNC-01	MNC-01	potassium, magnesium, and vitamins (MNC-01)
Placebo	Placebo	cellulose, microcrystalline \[NF\], HPMC E15,

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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%
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
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
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
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
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

Trial Locations

Locations (1)

Elke Parsi assoc. Prof. MD; 🇩🇪 Berlin, Germany