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

Cardiac Arrhythmia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02652338
• Other study ID #: MNC-01
• Status: Completed
• Phase: Phase 3
• First received: December 16, 2015
• Last updated: January 7, 2016
• Start date: April 2014
• Est. completion date: October 2015

Study information

• Verified date: January 2016
• Source: Trommsdorff GmbH & Co. KG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Ministry of Food, Agriculture and Consumer Protection
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Arrhythmia

Intervention

Dietary Supplement:
• MNC-01
twice daily 2 tablets with appr. 200 ml still water or tap water; duration: 6 weeks
• Placebo
twice daily 2 tablets with appr. 200 ml still water or tap water; duration: 6 weeks

Locations

Country	Name	City	State
Germany	Elke Parsi assoc. Prof. MD	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Trommsdorff GmbH & Co. KG	Bonn Education Association for Dietetics r.A., Cologne, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No