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

Trommsdorff GmbH & Co. KG74 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Cardiac Arrhythmia

Interventions

MNC-01DIETARY_SUPPLEMENT

twice daily 2 tablets with appr. 200 ml still water or tap water; duration: 6 weeks

PlaceboDIETARY_SUPPLEMENT

twice daily 2 tablets with appr. 200 ml still water or tap water; duration: 6 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Elke Parsi assoc. Prof. MD

Berlin, State of Berlin, Germany

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.