Influence of a Specific Micronutrient Combination on Symptom Awareness and Heart Rhythm in Patients With Cardiac Arrhythmia
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Trommsdorff GmbH & Co. KG
- Enrollment
- 74
- Locations
- 1
- Primary Endpoint
- Evaluation of the changes in the perception of six symptoms
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
MNC-01
potassium, magnesium, and vitamins (MNC-01)
Intervention: MNC-01 (Dietary Supplement)
Placebo
cellulose, microcrystalline [NF], HPMC E15,
Intervention: Placebo (Dietary Supplement)
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
- 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)
- 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)
- absolute reduction of supraventricular premature beats (SVPB)(end week 3 and week 6)
- responder rate(end week 3 and week 6)
Investigators
Christine Metzner Prof. Dr. Dr.
chief Executive Officer, Bonn Education Association for Dietetics r.A., Cologne, Germany
Trommsdorff GmbH & Co. KG