Influence of a Specific Micronutrient Combination on Symptom Awareness and Heart Rhythm in Patients With Cardiac Arrhythmia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Evaluation of the changes in the perception of six symptoms
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Evaluation of the changes in the perception of six symptoms
时间窗: 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
次要结局
- 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)
研究者
Christine Metzner Prof. Dr. Dr.
chief Executive Officer, Bonn Education Association for Dietetics r.A., Cologne, Germany
Trommsdorff GmbH & Co. KG