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

Trommsdorff

Status and phase

Completed

Phase 3

Conditions

Cardiac Arrhythmia

Treatments

Dietary Supplement: MNC-01

Dietary Supplement: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02652338

MNC-01

Details and patient eligibility

About

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.

Enrollment

74 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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