Influence of a Specific Micronutrient Combination on Symptom Awareness and Heart Rhythm in Patients With Cardiac Arrhythmia
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Cardiac Arrhythmia
- Sponsor
- Trommsdorff GmbH & Co. KG
- Enrollment
- 74
- Locations
- 1
- Primary Endpoint
- Evaluation of the changes in the perception of six symptoms
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
Christine Metzner Prof. Dr. Dr.
chief Executive Officer, Bonn Education Association for Dietetics r.A., Cologne, Germany
Trommsdorff GmbH & Co. KG
Eligibility 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
Outcomes
Primary Outcomes
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
- symptom awareness and changes during the study(end week 3 and week 6)
- symptom awareness and responder rate(end week 6)
- responder rate of the premature ventricular beat (PVB)(end week 3 and week 6)
- absolute reduction in premature ventricular beat (PVB)(end week 3 and 6 week)
- relative reduction of the premature ventricular beat (PVB)(end week 3 and week 6)
- relative reduction of supraventricular premature beats (SVPB)(end week 3 and week 6)
- absolute reduction of supraventricular premature beats (SVPB)(end week 3 and week 6)
- responder rate(end week 3 and week 6)