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Completed

NCT Number: NCT02652338

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

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.

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Key information

Conditions

Cardiac Arrhythmia Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Elke Parsi assoc. Prof. MD

Berlin, State of Berlin, 13053, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MNC-01

Dietary Supplement

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

Placebo

Dietary Supplement

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

Primary outcomes

  1. Evaluation of the changes in the perception of six symptoms

    Time frame: 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 outcomes

  1. symptom awareness and responder rate

    Time frame: 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%

  2. symptom awareness and changes during the study

    Time frame: 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

  3. absolute reduction in premature ventricular beat (PVB)

    Time frame: 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

  4. relative reduction of the premature ventricular beat (PVB)

    Time frame: 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

  5. responder rate of the premature ventricular beat (PVB)

    Time frame: 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

  6. absolute reduction of supraventricular premature beats (SVPB)

    Time frame: 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

  7. relative reduction of supraventricular premature beats (SVPB)

    Time frame: 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

  8. responder rate

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Trommsdorff GmbH & Co. KG

Industry

Collaborators

  • Bonn Education Association for Dietetics r.A., Cologne, Germany

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 11, 2016
Registry last updated
Jan 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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