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

Last updated: January 7, 2016
Sponsor: Trommsdorff GmbH & Co. KG
Overall Status: Completed

Phase

3

Condition

Atrial Flutter

Arrhythmia

Dysrhythmia

Treatment

N/A

Clinical Study ID

NCT02652338
MNC-01
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • PVB in the long-term ECG recording (registration at least 18 hours): at least 500PVB/24 h or Supraventricular tachycardia (≥10 episodes/24h, outside sporting activity)or SVPB with vegetative symptoms (increased sweating, inner unrest, shaky hands, reddermographism) and no cardial pretreatment

Exclusion

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 vitaminsand 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 stimulatinghormone)-value

  • Pacemaker

Study Design

Total Participants: 74
Study Start date:
April 01, 2014
Estimated Completion Date:
October 31, 2015

Connect with a study center

  • Elke Parsi assoc. Prof. MD

    Berlin, 13053
    Germany

    Site Not Available

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