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

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ClinicalTrials.gov Identifier: NCT02652338
Recruitment Status : Completed
First Posted : January 11, 2016
Last Update Posted : January 11, 2016
Sponsor:
Collaborator:
Bonn Education Association for Dietetics r.A., Cologne, Germany
Information provided by (Responsible Party):
Christine Metzner Prof. Dr. Dr., Trommsdorff GmbH & Co. KG

Brief 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.


Condition or disease Intervention/treatment Phase
Cardiac Arrhythmia Dietary Supplement: MNC-01 Dietary Supplement: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Influence of a Specific Micronutrient Combination on Symptom Awareness and Heart Rhythm in Patients With Cardiac Arrhythmia
Study Start Date : April 2014
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: MNC-01
potassium, magnesium, and vitamins (MNC-01)
Dietary Supplement: MNC-01
twice daily 2 tablets with appr. 200 ml still water or tap water; duration: 6 weeks

Placebo Comparator: Placebo
cellulose, microcrystalline [NF], HPMC E15,
Dietary Supplement: Placebo
twice daily 2 tablets with appr. 200 ml still water or tap water; duration: 6 weeks




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02652338


Locations
Germany
Elke Parsi assoc. Prof. MD
Berlin, Germany, 13053
Sponsors and Collaborators
Trommsdorff GmbH & Co. KG
Bonn Education Association for Dietetics r.A., Cologne, Germany
Investigators
Study Chair: Christine Metzner, Prof. MD Bonn Education Association for Dietetics r. A.

Responsible Party: Christine Metzner Prof. Dr. Dr., chief Executive Officer, Bonn Education Association for Dietetics r.A., Cologne, Germany, Trommsdorff GmbH & Co. KG
ClinicalTrials.gov Identifier: NCT02652338     History of Changes
Other Study ID Numbers: MNC-01
First Posted: January 11, 2016    Key Record Dates
Last Update Posted: January 11, 2016
Last Verified: January 2016

Keywords provided by Christine Metzner Prof. Dr. Dr., Trommsdorff GmbH & Co. KG:
heart rhythm disturbances and symptoms
dietary supplement

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes