Ventricular Premature ComplexesNCT04186728
Oral Magnesium Supplementation in Athletes With Premature Ventricular Contractions or Premature Atrial Contractions.
A study testing Magnesium glycinate in people with Ventricular Premature Complexes and Atrial Premature Complexes, run by University of British Columbia.
Trial summary
Magnesium is a mineral which is essential to many of the processes which happen in the body. This includes normal function of muscles; including the heart. Studies have shown that oral magnesium supplementation can help reduce the frequency of extra heart beats (premature ventricular contractions (PVC) and premature… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Ventricular Premature Complexes, Atrial Premature Complexes
- What is being tested?
- Magnesium glycinate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2020to 31 Dec 2021
- Phase
- Interventional
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Exercisers; defined as greater than 2.5 hours/week of at least moderate intensity exercise
- History of palpitations
- Average daily cumulative PVC/PAC count that is greater than 720 (measured with 48-hour Holter monitoring), AND/OR symptomatic from their PAC/PVCs
- Able to provide informed consent
- Able to participate in ongoing follow-up as required
- Able to swallow capsules
Who cannot join
- Current or regular use of an oral magnesium or calcium supplementation within the past year
- Current or regular use of a multivitamin or meal replacement product containing greater than 50mg of magnesium or 200mg of calcium within the past year
- Planning on becoming pregnant or currently pregnant or lactating
- Structural cardiac disease
- Documented atrial fibrillation
- Previous cardiac surgery including ablation for atrial fibrillation and/or ventricular arrhythmia
Show all 16Show fewer
- Use of antiarrhythmic drugs, beta-blockers, calcium channel blockers, OR diuretics
- Hypomagnesemia (serum magnesium less than 0.7)
- Bilirubin (greater than or equal to 3mg/dL)
- Aspartate transaminase (AST) or alanine transaminase (ALT) greater than or equal to five times the upper limits of normal
- Glomerular filtration rate (GFR) less than 60
- Current or previous (within the four weeks prior to enrollment) use of any proton pump inhibitor (omeprazole, pantoprazole,), Gentamycin, Tobramycin, Amphotericin B, Ketoconazole, Mephalan, Eroposide, aminoglycosides or medication deemed by the PI as contraindicated)
- Alcohol intake greater than 15 standard drinks/week for men or greater than 10 standard drinks/week for women
- Illicit drug use
- Diabetes mellitus, kidney disease, irritable bowel disease or neuromuscular disease
- Diagnosis of cancer within the past five years (except basal/squamous cell limited to the skin)
Trial locations and contacts
No sites are listed yet.
About this study
Magnesium is a mineral which is essential to many of the processes which happen in the body. This includes normal function of muscles; including the heart. Studies have shown that oral magnesium supplementation can help reduce the frequency of extra heart beats (premature ventricular contractions (PVC) and premature atrial contractions (PAC)) while also reducing the severity of their associated symptoms. Oral magnesium supplementation has yet to be investigated in athletes with lots of PVCs and/or PACs.
Most of the magnesium in your body is stored in the bones. Your body may take magnesium from your bones to maintain magnesium levels in your blood. This makes it possible for people to have low levels of magnesium in their body but normal levels in their blood. Over time, this process can decrease the total amount in your body and impact other body functions. Magnesium is also lost in sweat making athletes more vulnerable to having low levels in their body.
Read more
Magnesium is particularly important in the function of the myocardium (heart muscle fibers). It has been proposed that the PVCs and PACs experienced by some people are a result of low levels of total body magnesium. Current drug treatments to control PVCs and PACs include medications such as beta blockers. These treatments are not without their side effects. Generally, these medications are only effective if individuals do not have a structural heart disease. These drugs may also decrease your ability to exercise and are banned by some governing bodies in sport.
The hypotheses of this study are:
- Oral magnesium supplementation reduces the frequency of PVCs and/or PACs.
- Oral magnesium supplementation reduces the symptoms associated with PVCs and PACs.
To be eligible for the study, individuals will be required to have a certain number of PVCs and PACs in a day. This study will involve two groups of participants. A total of 25 participants will be recruited for each group resulting in 50 participants in the study. During the study, one group will take a daily magnesium capsule for 12 weeks before switching to a placebo for 12 weeks. The other group will have the placebo intervention before switching to magnesium. Participants will be randomized into one of the two groups and will remain blinded until their participation in the study ends. The research team will also be unaware of each participant's current intervention however, this information will be available in case of medical emergency.
Participants will be asked to attend one screening visit and three study visits. During these visits, a blood sample will be taken and you will be asked to complete questionnaires about you physical fitness and quality of life. You will also be asked to wear a Holter monitor for 48 hours in order to count the number of PVCs and PACs you have daily. In addition to these assessments, you will also complete an exercise stress test during your screening visit.
- Being tested
- Magnesium glycinate, Placebo
- Keywords
- athlete, premature ventricular contraction, premature atrial contraction, ectopic heartbeat, palpitation
- Medical subject headings
- Ventricular Premature Complexes, Atrial Premature Complexes, Cardiac Complexes, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium glycinateDietary supplement
Daily magnesium capsule.
PlaceboOther
Daily placebo capsule.
| Study group | Role | What they receive |
|---|---|---|
| Placebo to magnesium | Placebo comparator | Participants will be asked to consume a daily placebo (cellulose) capsule for 12 weeks. They will then cross-over and consume 200mg of elemental magnesium in the form of magnesium glycinate daily for 12 weeks. Receives: Dietary Supplement: Magnesium glycinate; Other: Placebo |
| Magnesium to placebo | Experimental | Participants will be asked to consume 200mg of elemental magnesium in the form of magnesium glycinate daily. They will then cross-over and consume a daily placebo (cellulose) capsule for 12 weeks. Receives: Dietary Supplement: Magnesium glycinate; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
PAC burden total, magnesium intervention
Average number of premature atrial contractions in a hour. Assessed with 48-hour Holter monitoring.
Measured: Change in PAC burden after 12 weeks of magnesium intervention
PVC burden total, magnesium intervention
Average number of premature ventricular contractions in a hour. Assessed with 48-hour Holter monitoring.
Measured: Change in PVC burden after 12 weeks of magnesium intervention
Cardiac symptom burden, magnesium intervention
The number of patient reported symptoms that correspond with documented PVCs or PACs (some participants may be experiencing palpitations but may not actually be symptomatic).
Measured: Change in cardiac symptom burden after 12 weeks of magnesium intervention
PAC burden total, placebo intervention
Average number of premature atrial contractions in a hour. Assessed with 48-hour Holter monitoring.
Measured: Change in PAC burden after 12 weeks of placebo intervention
PVC burden total, placebo intervention
Average number of premature ventricular contractions in a hour. Assessed with 48-hour Holter monitoring.
Measured: Change in PVC burden after 12 weeks of placebo intervention
Cardiac symptom burden, placebo intervention
The number of patient reported symptoms that correspond with documented PVCs or PACs (some participants may be experiencing palpitations but may not actually be symptomatic).
Measured: Change in cardiac symptom burden after 12 weeks of placebo intervention
Secondary outcomes (10)
Number of ectopic runs, magnesium intervention
Average number of ectopic runs (>3 beats) per day. Assessed with 48-hour Holter monitoring.
Measured: Change in number of ectopic runs after 12 weeks of magnesium intervention
Number of sustained arrhythmias, magnesium intervention
Average number of sustained arrhythmias (>30 seconds) per day. Assessed with 48-hour Holter monitoring.
Measured: Change in number of sustained arrhythmias after 12 weeks of magnesium intervention
Subjective Quality of Life (questionnaire), magnesium intervention
The palpitation questionnaire is comprised of 12 questions (4 focused on the extent to which participants are bothered by symptoms associated with palpitations, 2 focused on the extent to which participants feel limited in their daily life due to palpitations, and 6 focused on the difficulty that participants feel in doing daily activities due to palpitations). Responses are given on a 7-point scale where 1 represents being not at all bothered, limited or experiencing no difficulty, and 7 represents being extremely bothered, limited or experiencing extreme difficulty.
Measured: Change in subjective quality of life after 12 weeks of magnesium intervention
Gastrointestinal symptom burden, magnesium intervention
Participants will be asked to report gastrointestinal symptoms every time they occur. This consists of the symptoms they are experiencing (i.e. nausea, bloating, heart burn, etc.) as well as symptom severity. Severity will be ranked between 1 and 5 where 1 means the symptoms were barely noticeable and did not affect daily life and, 5 means that the participant had to stop what they were doing to rest or that they had to alter their plans.
Measured: Number of Gastrointestinal symptoms over 12 weeks of magnesium intervention
Subjective performance changes, magnesium intervention
Changes in physical performance will be assessed with a questionnaire inquiring about injuries, average intensity of exercise (ranked from 0 to 10, 0 being no activity at all and 10 being regular maximal effort training), perceived ability to recover after exercise bouts and typical volume (time, distance and load/weight).
Measured: Change in subjective physical performance after 12 weeks of magnesium intervention
Number of ectopic runs, placebo intervention
Average number of ectopic runs (>3 beats) per day. Assessed with 48-hour Holter monitoring.
Measured: Change in number of ectopic runs after 12 weeks of placebo intervention
Number of sustained arrhythmias, placebo intervention
Average number of sustained arrhythmias (>30 seconds) per day. Assessed with 48-hour Holter monitoring.
Measured: Change in number of sustained arrhythmias after 12 weeks of placebo intervention
Subjective Quality of Life (questionnaire), placebo intervention
The palpitation questionnaire is comprised of 12 questions (4 focused on the extent to which participants are bothered by symptoms associated with palpitations, 2 focused on the extent to which participants feel limited in their daily life due to palpitations, and 6 focused on the difficulty that participants feel in doing daily activities due to palpitations). Responses are given on a 7-point scale where 1 represents being not at all bothered, limited or experiencing no difficulty, and 7 represents being extremely bothered, limited or experiencing extreme difficulty.
Measured: Change in subjective quality of life after 12 weeks of placebo intervention
Gastrointestinal symptom burden, placebo intervention
Participants will be asked to report gastrointestinal symptoms every time they occur. This consists of the symptoms they are experiencing (i.e. nausea, bloating, heart burn, etc.) as well as symptom severity. Severity will be ranked between 1 and 5 where 1 means the symptoms were barely noticeable and did not affect daily life and, 5 means that the participant had to stop what they were doing to rest or that they had to alter their plans.
Measured: Number of Gastrointestinal symptoms over 12 weeks of the placebo intervention.
Subjective performance changes, placebo intervention
Changes in physical performance will be assessed with a questionnaire inquiring about injuries, average intensity of exercise (ranked from 0 to 10, 0 being no activity at all and 10 being regular maximal effort training), perceived ability to recover after exercise bouts and typical volume (time, distance and load/weight).
Measured: Change in subjective physical performance after 12 weeks of the placebo intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start30 Sep 2020 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular Premature ComplexesStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized double blinded placebo controlled experiment
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James McKinney, University of British Columbia
- Investigators
- James McKinney, MD, FRCP, MSc, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04186728
- Sponsor's protocol ID
- H19-01142
- Status last verified
- Jul 2020
- First submitted
- 28 Nov 2019
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no current plans to share data with other researchers. This will only be reconsidered if the journal that the manuscript is submitted to requests that the study data be made public.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Magnesium Supplementation in Athletes With Premature Ventricular Contractions or Premature Atrial Contractions.
- ClinicalTrials.gov ID
- NCT04186728
- Acronym / sponsor ID
- H19-01142
- Keywords
- athlete, premature ventricular contraction, premature atrial contraction, ectopic heartbeat, palpitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 30 Sep 2020 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 5 Dec 2019 (actual)
- 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.
Magnesium is a mineral which is essential to many of the processes which happen in the body. This includes normal function of muscles; including the heart. Studies have shown that oral magnesium supplementation can help reduce the frequency of extra heart beats (premature ventricular contractions (PVC) and premature atrial contractions (PAC)) while also reducing the severity of their associated symptoms. Oral magnesium supplementation has yet to be investigated in athletes with lots of PVCs and/or PACs.
Most of the magnesium in your body is stored in the bones. Your body may take magnesium from your bones to maintain magnesium levels in your blood. This makes it possible for people to have low levels of magnesium in their body but normal levels in their blood. Over time, this process can decrease the total amount in your body and impact other body functions. Magnesium is also lost in sweat making athletes more vulnerable to having low levels in their body.
Magnesium is particularly important in the function of the myocardium (heart muscle fibers). It has been proposed that the PVCs and PACs experienced by some people are a result of low levels of total body magnesium. Current drug treatments to control PVCs and PACs include medications such as beta blockers. These treatments are not without their side effects. Generally, these medications are only effective if individuals do not have a structural heart disease. These drugs may also decrease your ability to exercise and are banned by some governing bodies in sport.
The hypotheses of this study are:
- Oral magnesium supplementation reduces the frequency of PVCs and/or PACs.
- Oral magnesium supplementation reduces the symptoms associated with PVCs and PACs.
To be eligible for the study, individuals will be required to have a certain number of PVCs and PACs in a day. This study will involve two groups of participants. A total of 25 participants will be recruited for each group resulting in 50 participants in the study. During the study, one group will take a daily magnesium capsule for 12 weeks before switching to a placebo for 12 weeks. The other group will have the placebo intervention before switching to magnesium. Participants will be randomized into one of the two groups and will remain blinded until their participation in the study ends. The research team will also be unaware of each participant's current intervention however, this information will be available in case of medical emergency.
Participants will be asked to attend one screening visit and three study visits. During these visits, a blood sample will be taken and you will be asked to complete questionnaires about you physical fitness and quality of life. You will also be asked to wear a Holter monitor for 48 hours in order to count the number of PVCs and PACs you have daily. In addition to these assessments, you will also complete an exercise stress test during your screening visit.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized double blinded placebo controlled experiment
| Arm | Type | Receives |
|---|---|---|
| Placebo to magnesium | Placebo comparator | Dietary Supplement: Magnesium glycinate, Other: PlaceboParticipants will be asked to consume a daily placebo (cellulose) capsule for 12 weeks. They will then cross-over and consume 200mg of elemental magnesium in the form of magnesium glycinate daily for 12 weeks. |
| Magnesium to placebo | Experimental | Dietary Supplement: Magnesium glycinate, Other: PlaceboParticipants will be asked to consume 200mg of elemental magnesium in the form of magnesium glycinate daily. They will then cross-over and consume a daily placebo (cellulose) capsule for 12 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Exercisers; defined as greater than 2.5 hours/week of at least moderate intensity exercise
- History of palpitations
- Average daily cumulative PVC/PAC count that is greater than 720 (measured with 48-hour Holter monitoring), AND/OR symptomatic from their PAC/PVCs
- Able to provide informed consent
- Able to participate in ongoing follow-up as required
Key exclusion criteria (16 listed)
- Current or regular use of an oral magnesium or calcium supplementation within the past year
- Current or regular use of a multivitamin or meal replacement product containing greater than 50mg of magnesium or 200mg of calcium within the past year
- Planning on becoming pregnant or currently pregnant or lactating
- Structural cardiac disease
- Documented atrial fibrillation
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 |
|---|---|---|
| Magnesium glycinateDaily magnesium capsule. | Dietary supplement | Magnesium to placebo, Placebo to magnesium |
| PlaceboDaily placebo capsule. | Other | Magnesium to placebo, Placebo to magnesium |
Primary outcome
PAC burden total, magnesium intervention
Time frame: Change in PAC burden after 12 weeks of magnesium intervention
Average number of premature atrial contractions in a hour. Assessed with 48-hour Holter monitoring.
PVC burden total, magnesium intervention
Time frame: Change in PVC burden after 12 weeks of magnesium intervention
Average number of premature ventricular contractions in a hour. Assessed with 48-hour Holter monitoring.
Cardiac symptom burden, magnesium intervention
Time frame: Change in cardiac symptom burden after 12 weeks of magnesium intervention
The number of patient reported symptoms that correspond with documented PVCs or PACs (some participants may be experiencing palpitations but may not actually be symptomatic).
PAC burden total, placebo intervention
Time frame: Change in PAC burden after 12 weeks of placebo intervention
Average number of premature atrial contractions in a hour. Assessed with 48-hour Holter monitoring.
PVC burden total, placebo intervention
Time frame: Change in PVC burden after 12 weeks of placebo intervention
Average number of premature ventricular contractions in a hour. Assessed with 48-hour Holter monitoring.
Cardiac symptom burden, placebo intervention
Time frame: Change in cardiac symptom burden after 12 weeks of placebo intervention
The number of patient reported symptoms that correspond with documented PVCs or PACs (some participants may be experiencing palpitations but may not actually be symptomatic).
10 secondary outcomes
Number of ectopic runs, magnesium intervention
Time frame: Change in number of ectopic runs after 12 weeks of magnesium intervention
Number of sustained arrhythmias, magnesium intervention
Time frame: Change in number of sustained arrhythmias after 12 weeks of magnesium intervention
Subjective Quality of Life (questionnaire), magnesium intervention
Time frame: Change in subjective quality of life after 12 weeks of magnesium intervention
Gastrointestinal symptom burden, magnesium intervention
Time frame: Number of Gastrointestinal symptoms over 12 weeks of magnesium intervention
Subjective performance changes, magnesium intervention
Time frame: Change in subjective physical performance after 12 weeks of magnesium intervention
Number of ectopic runs, placebo intervention
Time frame: Change in number of ectopic runs after 12 weeks of placebo intervention
Number of sustained arrhythmias, placebo intervention
Time frame: Change in number of sustained arrhythmias after 12 weeks of placebo intervention
Subjective Quality of Life (questionnaire), placebo intervention
Time frame: Change in subjective quality of life after 12 weeks of placebo intervention
Gastrointestinal symptom burden, placebo intervention
Time frame: Number of Gastrointestinal symptoms over 12 weeks of the placebo intervention.
Subjective performance changes, placebo intervention
Time frame: Change in subjective physical performance after 12 weeks of the placebo intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
- Individual participant dataSharing planned: No. There are no current plans to share data with other researchers. This will only be reconsidered if the journal that the manuscript is submitted to requests that the study data be made public.
Related trials for Ventricular Premature Complexes
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Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
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AI-Based Differential Diagnosis and Localization of Tachycardia Using ECG: Multicenter Registry (EP-AI ASSIST)
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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.
James McKinney, MD, FRCP, MSc principal investigator
University of British Columbia
Questions about this trial
What is this clinical trial studying?
A study testing Magnesium glycinate in people with Ventricular Premature Complexes and Atrial Premature Complexes, run by University of British Columbia.
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 6 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 29 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raymond Tran, MSc (604-822-9494, raymond.tran@vch.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PAC burden total, magnesium intervention (time frame: Change in PAC burden after 12 weeks of magnesium intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jul 2020.