Cardiac ArrhythmiaPhase 3NCT02652338
Dietary Supplement on Symptom Awareness and Heart Rhythm in Patients With Cardiac Arrhythmia
A Phase 3 study testing MNC-01 in people with Cardiac Arrhythmia, run by Trommsdorff GmbH & Co. KG at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cardiac Arrhythmia
- What is being tested?
- MNC-01
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2014to Oct 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of a Specific Micronutrient Combination on Symptom Awareness and Heart Rhythm in Patients With Cardiac Arrhythmia
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.
- Conditions
- Cardiac Arrhythmia
- Being tested
- MNC-01, Placebo
- Keywords
- heart rhythm disturbances and symptoms, dietary supplement
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MNC-01Dietary supplement
twice daily 2 tablets with appr. 200 ml still water or tap water; duration: 6 weeks
PlaceboDietary supplement
twice daily 2 tablets with appr. 200 ml still water or tap water; duration: 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| MNC-01 | Active comparator | potassium, magnesium, and vitamins (MNC-01) Receives: Dietary Supplement: MNC-01 |
| Placebo | Placebo comparator | cellulose, microcrystalline [NF], HPMC E15, Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the changes in the perception of six symptoms
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
Measured: end week 3 and week 6
Secondary outcomes (8)
symptom awareness and responder rate
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%
Measured: end week 6
symptom awareness and changes during the study
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
Measured: end week 3 and week 6
absolute reduction in premature ventricular beat (PVB)
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
Measured: end week 3 and 6 week
relative reduction of the premature ventricular beat (PVB)
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
Measured: end week 3 and week 6
responder rate of the premature ventricular beat (PVB)
the responder rate measured by the amount of patients with a reduction of the PVB of at least 5 % at the end of study
Measured: end week 3 and week 6
absolute reduction of supraventricular premature beats (SVPB)
the absolute reduction of the SVPB in 24 hours in combination with a reduction of the awareness of the six symptoms
Measured: end week 3 and week 6
relative reduction of supraventricular premature beats (SVPB)
the relative reduction of the SVPB in 24 hours in combination with a reduction of the awareness of the six symptoms
Measured: end week 3 and week 6
responder rate
the responder rate, measured by the amount of patients with a reduction of the PVB of at least 5 % at the end of study
Measured: end week 3 and week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2016 (estimated)
- Study startApr 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrhythmiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trommsdorff GmbH & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bonn Education Association for Dietetics r.A., Cologne, Germany
- Responsible party
- Principal investigator, Christine Metzner Prof. Dr. Dr., Trommsdorff GmbH & Co. KG
- Investigators
- Christine Metzner, Prof. MD, Study chair, Bonn Education Association for Dietetics r. A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02652338
- Sponsor's protocol ID
- MNC-01
- Status last verified
- Jan 2016
- First submitted
- 16 Dec 2015
- Last updated
- 11 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30509185
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of a Specific Micronutrient Combination on Symptom Awareness and Heart Rhythm in Patients With Cardiac Arrhythmia
- ClinicalTrials.gov ID
- NCT02652338
- Acronym / sponsor ID
- MNC-01
- Conditions
- Cardiac Arrhythmia
- Keywords
- heart rhythm disturbances and symptoms, dietary supplement
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Trommsdorff GmbH & Co. KGIndustry (pharma, biotech, devices)
- Collaborators
- Bonn Education Association for Dietetics r.A., Cologne, Germany
- Study start
- Apr 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 11 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MNC-01 | Active comparator | Dietary Supplement: MNC-01potassium, magnesium, and vitamins (MNC-01) |
| Placebo | Placebo comparator | Dietary Supplement: Placebocellulose, microcrystalline [NF], HPMC E15, |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MNC-01twice daily 2 tablets with appr. 200 ml still water or tap water; duration: 6 weeks | Dietary supplement | MNC-01 |
| Placebotwice daily 2 tablets with appr. 200 ml still water or tap water; duration: 6 weeks | Dietary supplement | Placebo |
Primary outcome
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
8 secondary outcomes
symptom awareness and responder rate
Time frame: end week 6
symptom awareness and changes during the study
Time frame: end week 3 and week 6
absolute reduction in premature ventricular beat (PVB)
Time frame: end week 3 and 6 week
relative reduction of the premature ventricular beat (PVB)
Time frame: end week 3 and week 6
responder rate of the premature ventricular beat (PVB)
Time frame: end week 3 and week 6
absolute reduction of supraventricular premature beats (SVPB)
Time frame: end week 3 and week 6
relative reduction of supraventricular premature beats (SVPB)
Time frame: end week 3 and week 6
responder rate
Time frame: end week 3 and week 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2016.
- Derived from this study: PubMed 30509185Parsi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine Metzner, Prof. MD study chair
Bonn Education Association for Dietetics r. A.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MNC-01 in people with Cardiac Arrhythmia, run by Trommsdorff GmbH & Co. KG at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the changes in the perception of six symptoms (time frame: end week 3 and week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02652338, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2016.