Clinical trial NCT02652338: Dietary Supplement on Symptom Awareness and Heart Rhythm in Patients With Cardiac Arrhythmia
Official title: Influence of a Specific Micronutrient Combination on Symptom Awareness and Heart Rhythm in Patients With Cardiac Arrhythmia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cardiac Arrhythmia
Keywords: heart rhythm disturbances and symptoms
dietary supplement
Lead sponsor: Trommsdorff GmbH & Co. KG
Sponsor class: INDUSTRY
Collaborators: name: Bonn Education Association for Dietetics r.A., Cologne, Germany
First posted: 2016-01-11
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Evaluation of the changes in the perception of six symptoms
timeFrame: end week 3 and week 6
Secondary outcomes:
measure: symptom awareness and responder rate
timeFrame: end week 6
measure: symptom awareness and changes during the study
timeFrame: end week 3 and week 6
measure: absolute reduction in premature ventricular beat (PVB)
timeFrame: end week 3 and 6 week
measure: relative reduction of the premature ventricular beat (PVB)
timeFrame: end week 3 and week 6
measure: responder rate of the premature ventricular beat (PVB)
timeFrame: end week 3 and week 6
measure: absolute reduction of supraventricular premature beats (SVPB)
timeFrame: end week 3 and week 6
measure: relative reduction of supraventricular premature beats (SVPB)
timeFrame: end week 3 and week 6
measure: responder rate
timeFrame: end week 3 and week 6
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Elke Parsi assoc. Prof. MD
Study officials:
affiliation: Bonn Education Association for Dietetics r. A.
name: Christine Metzner, Prof. MD
role: STUDY_CHAIR
References:
citation: Parsi E, Bitterlich N, Winkelmann A, Rosler D, Metzner C. Dietary intervention with a specific micronutrient combination for the treatment of patients with cardiac arrhythmias: the impact on insulin resistance and left ventricular function. BMC Cardiovasc Disord. 2018 Dec 3;18(1):220. doi: 10.1186/s12872-018-0954-6.