HypertensionNCT03783117
Magneto-rheology to Lower Blood Pressure
A study testing Magnetic field treatment in people with Hypertension, run by Cardiovascular Therapy LLC at 1 site in United States.
Trial summary
Heart attacks and strokes are the leading causes of death in US. High blood viscosity and turbulence in blood flow are the key for cardiovascular diseases. Recent research has shown that application of a strong magnetic field along the blood flow direction will polarize the red blood cells and align them into short… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Magnetic field treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Aug 2018to 31 Aug 2019
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The systolic blood pressure in a range of 140-180 mmHg or diastolic blood pressure in a range 90-120 mmHg.
Who cannot join
- Subjects with a pacemaker or other metallic devices implanted.
- Adults unable to consent,
- Cognitively impaired adults,
- Pregnant women,
- Prisoners.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Magnetic Blood Pressure Lowering Device Study
Philadelphia, Pennsylvania, 19122
Rongjia Tao, 215-204-7651, rtao@temple.edu
About this study
Official title: Reducing Blood Viscosity and Suppressing Turbulence With Magneto-rheology to Lower Blood Pressure
Heart attacks and strokes are the leading causes of death in US. High blood viscosity and turbulence in blood flow are the key for cardiovascular diseases. Recent research has shown that application of a strong magnetic field along the blood flow direction will polarize the red blood cells and align them into short chains along the flow, so that the blood viscosity in the flow direction is reduced significantly and disturbed motions in the directions perpendicular to the flow is suppressed. This makes the blood flow laminar, turbulence suppressed, and the possibility of cardiac events reduced. Such magnet treatment also cures rouleaux and improves the blood's oxygen function. The lab tests also confirm that the above effects last more than 24 hours after one treatment.
The purpose of this trial is to apply this technology to humans. According to the lab tests, this magnetic treatment has the potential to bring the following benefits to the subjects: (a)The blood viscosity will be reduced by 10-20% or more. (b) The turbulence in blood circulation will be suppressed by the treatment. After the treatment, the blood flow will be laminar. As a joint effect of viscosity reduction and turbulence suppression, the blood pressure will be lowered by 10-20% or more. (c) The subject's blood oxygen function will be improved by the treatment. Especially, if the subject has rouleaux in his/her blood, the effect will be significant. (d) The above effects will last for about 24 hours after one treatment and slowly decay; however, re-treatment will bring the effects back. (e) Because steady laminar blood flow is atheroprotective by active reduction of inflammatory genes, the magnetic treatment, reducing disturbed blood flow hemodynamics, would be possible to have a long term effect as an anti-atherogenic therapy if the treatment keeps for a while.
The investigators have just completed the pilot clinical trial. The tests confirm that the technology is safe and effective in lowering the blood pressure and the effect lasts about 24 hours. The present pivotal clinical trials are the continuation and expansion of the pilot tests. The successful clinical trials will make this technology available for people in preventing heart attack and stroke.
Read the detailed description
GOAL: Conduct pivotal clinical trials with Magnetic Blood Pressure Lowering (MBPL) Device, developed in this lab, to see how effective it can lower patients' high blood pressure. The pilot study has confirmed the safety and performance of the device. The pivotal tests will test a large population of subject with hypertension to determine the effectiveness of the MBPL device and check if there is any adverse effect.
RECRUITMENT: For the pivotal clinical trials, subjects in second stage of hypertension will be selected: the systolic blood pressure in a range of 140-180 mmHg or diastolic blood pressure in a range 90-120 mmHg. For safety, subjects, who have a pacemaker or other metallic devices implanted, will not be selected. In addition, any adults unable to consent, cognitively impaired adults, and subjects who are not yet adults (infants, children, teenagers), pregnant women, and prisoners, will not be admitted.
STUDY: The MBPL device for clinical trials is made with modification of an electromagnet: A bore of 10 cm diameter was made to go through the frame and poles. The device can produce a magnetic field close to 1.0 T inside the bore, which is along the axis direction. The trial for each subject takes about 20-30 minutes. The subject's blood pressure will be measured first. Afterwards, the subject will place his/her right arm into the bore of the electromagnet for treatment while the blood pressure is monitored with the left arm. The magnetic treatment will last about 15 minutes.
In order to see how long the effect lasts, the subject needs to return and measure the blood pressure again 24 hours after the treatment. The clinical trials are non-invasive. There is no medicine or surgery involved.
ANALYSES: During the magnetic treatment, the MBPL device applies a strong magnetic field along the blood flow direction in subjects' right arm. Under the magnetic field, the deoxygenated red blood cells are polarized and form short chains along the blood flow direction. The blood circulation brings these chains to the whole body. Based on the lab results, the blood viscosity along the flow direction will be reduced by 10-20% or more; the turbulence in blood circulation will be suppressed by the treatment if the subject has turbulence in the blood circulation. As a result, the blood flow will become laminar and the blood pressure will be lowered. The above effects will last for about 24 hours after the treatment and slowly decay. However, re-treatment will bring the effects back. In long term, the magnetic treatment could prevent development of atherosclerotic plaques in blood vessels. The effectiveness of the magnetic treatment will be determined by
- evaluating the reduction of the systolic blood pressure and diastolic blood pressure immediately after the magnetic treatment;
- comparing the blood pressure 24 hours after the magnetic treatment with the initial blood pressure before the magnetic treatment and evaluating any reduction.
- Conditions
- Hypertension
- Being tested
- Magnetic field treatment
- Keywords
- Hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic field treatmentDevice
The MBPL device for clinical trials is made with modification of an electromagnet: A bore of 10cm diameter was made to go through the frame and poles. The device can produce a magnetic field close to 1.0 T inside the bore, which is along the axis direction. The trial for each subject takes about 20-30 minutes. To start with, the subject's blood pressure is measured first as the baseline. Afterwards, the subject places his/her right arm into the bore of the electromagnet for treatment while the blood pressure is monitored with the left arm. The magnetic treatment lasts about 15 minutes and will lower the subject's blood pressure. In order to see how long the effect lasts, the subject needs to return and measure the blood pressure again 24 hours after the treatment. The clinical trials are non-invasive. There is no medicine or surgery involved.
| Study group | Role | What they receive |
|---|---|---|
| Magnetic field treatment | Experimental | Each subject will place his/her right arm into a bore of the Magnetic Blood Pressure Lowering (MBPL) Device for magnetic treatment of 15 minutes, while the blood pressure is monitored with the left arm. The MBPL device produces a magnetic field around 1T parallel to the blood flow inside the arm. The subject's blood pressure will be lowered. The subject needs to come back to check the blood pressure 24 hours after the treatment. Receives: Device: Magnetic field treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Blood Pressure at the End of Magnetic Treatment
Measure and evaluate the change of both systolic blood pressure and diastolic blood pressure from the baseline at the end of magnetic treatment.
Measured: Through study completion, an average of 1 year
Secondary outcomes (1)
Change of Blood Pressure 24 Hours after the Magnetic Treatment
Measure and evaluate the change of both systolic blood pressure and diastolic blood pressure from the baseline 24 hours after the magnetic treatment
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2018
- Study start10 Aug 2018
- Primary completion9 Aug 2019 (estimated)
- Study completion31 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Subjects in second stage of hypertension: the systolic blood pressure in a range of 140-180 mmHg or diastolic blood pressure in a range 90-120 mmHg. For safety, subjects, who have a pacemaker or other metallic devices implanted, will not be admitted.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cardiovascular Therapy LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Rongjia Tao, Cardiovascular Therapy LLC
- Investigators
- Rongjia Tao, Ph.D., Principal investigator, Cardiovascular Therapy LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03783117
- Sponsor's protocol ID
- 201801
- Status last verified
- Dec 2018
- First submitted
- 18 Dec 2018
- Last updated
- 20 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Tao R, Huang K. Reducing blood viscosity with magnetic fields. Phys Rev E Stat Nonlin Soft Matter Phys. 2011 Jul;84(1 Pt 1):011905. doi: 10.1103/PhysRevE.84.011905. Epub 2011 Jul 12.
PubMed 21867211Tao R, Tang H, Xu X, Tawhid-Al-Islam K, Du E, "Systems and methods for reducing the viscosity of blood, suppressing turbulence in blood circulation, and curing rouleaux" PCT/US2017/059446, WO2018/085330A4
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Blood Viscosity and Suppressing Turbulence With Magneto-rheology to Lower Blood Pressure
- ClinicalTrials.gov ID
- NCT03783117
- Acronym / sponsor ID
- 201801
- Conditions
- Hypertension
- Keywords
- Hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Cardiovascular Therapy LLCIndustry (pharma, biotech, devices)
- Study start
- 10 Aug 2018 (actual)
- Primary completion
- 9 Aug 2019 (estimated)
- Study completion
- 31 Aug 2019 (estimated)
- First posted
- 20 Dec 2018 (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.
Heart attacks and strokes are the leading causes of death in US. High blood viscosity and turbulence in blood flow are the key for cardiovascular diseases. Recent research has shown that application of a strong magnetic field along the blood flow direction will polarize the red blood cells and align them into short chains along the flow, so that the blood viscosity in the flow direction is reduced significantly and disturbed motions in the directions perpendicular to the flow is suppressed. This makes the blood flow laminar, turbulence suppressed, and the possibility of cardiac events reduced. Such magnet treatment also cures rouleaux and improves the blood's oxygen function. The lab tests also confirm that the above effects last more than 24 hours after one treatment.
The purpose of this trial is to apply this technology to humans. According to the lab tests, this magnetic treatment has the potential to bring the following benefits to the subjects: (a)The blood viscosity will be reduced by 10-20% or more. (b) The turbulence in blood circulation will be suppressed by the treatment. After the treatment, the blood flow will be laminar. As a joint effect of viscosity reduction and turbulence suppression, the blood pressure will be lowered by 10-20% or more. (c) The subject's blood oxygen function will be improved by the treatment. Especially, if the subject has rouleaux in his/her blood, the effect will be significant. (d) The above effects will last for about 24 hours after one treatment and slowly decay; however, re-treatment will bring the effects back. (e) Because steady laminar blood flow is atheroprotective by active reduction of inflammatory genes, the magnetic treatment, reducing disturbed blood flow hemodynamics, would be possible to have a long term effect as an anti-atherogenic therapy if the treatment keeps for a while.
The investigators have just completed the pilot clinical trial. The tests confirm that the technology is safe and effective in lowering the blood pressure and the effect lasts about 24 hours. The present pivotal clinical trials are the continuation and expansion of the pilot tests. The successful clinical trials will make this technology available for people in preventing heart attack and stroke.
Detailed description
GOAL: Conduct pivotal clinical trials with Magnetic Blood Pressure Lowering (MBPL) Device, developed in this lab, to see how effective it can lower patients' high blood pressure. The pilot study has confirmed the safety and performance of the device. The pivotal tests will test a large population of subject with hypertension to determine the effectiveness of the MBPL device and check if there is any adverse effect.
RECRUITMENT: For the pivotal clinical trials, subjects in second stage of hypertension will be selected: the systolic blood pressure in a range of 140-180 mmHg or diastolic blood pressure in a range 90-120 mmHg. For safety, subjects, who have a pacemaker or other metallic devices implanted, will not be selected. In addition, any adults unable to consent, cognitively impaired adults, and subjects who are not yet adults (infants, children, teenagers), pregnant women, and prisoners, will not be admitted.
STUDY: The MBPL device for clinical trials is made with modification of an electromagnet: A bore of 10 cm diameter was made to go through the frame and poles. The device can produce a magnetic field close to 1.0 T inside the bore, which is along the axis direction. The trial for each subject takes about 20-30 minutes. The subject's blood pressure will be measured first. Afterwards, the subject will place his/her right arm into the bore of the electromagnet for treatment while the blood pressure is monitored with the left arm. The magnetic treatment will last about 15 minutes.
In order to see how long the effect lasts, the subject needs to return and measure the blood pressure again 24 hours after the treatment. The clinical trials are non-invasive. There is no medicine or surgery involved.
ANALYSES: During the magnetic treatment, the MBPL device applies a strong magnetic field along the blood flow direction in subjects' right arm. Under the magnetic field, the deoxygenated red blood cells are polarized and form short chains along the blood flow direction. The blood circulation brings these chains to the whole body. Based on the lab results, the blood viscosity along the flow direction will be reduced by 10-20% or more; the turbulence in blood circulation will be suppressed by the treatment if the subject has turbulence in the blood circulation. As a result, the blood flow will become laminar and the blood pressure will be lowered. The above effects will last for about 24 hours after the treatment and slowly decay. However, re-treatment will bring the effects back. In long term, the magnetic treatment could prevent development of atherosclerotic plaques in blood vessels. The effectiveness of the magnetic treatment will be determined by
- evaluating the reduction of the systolic blood pressure and diastolic blood pressure immediately after the magnetic treatment;
- comparing the blood pressure 24 hours after the magnetic treatment with the initial blood pressure before the magnetic treatment and evaluating any reduction.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Subjects in second stage of hypertension: the systolic blood pressure in a range of 140-180 mmHg or diastolic blood pressure in a range 90-120 mmHg. For safety, subjects, who have a pacemaker or other metallic devices implanted, will not be admitted.
| Arm | Type | Receives |
|---|---|---|
| Magnetic field treatment | Experimental | Device: Magnetic field treatmentEach subject will place his/her right arm into a bore of the Magnetic Blood Pressure Lowering (MBPL) Device for magnetic treatment of 15 minutes, while the blood pressure is monitored with the left arm. The MBPL device produces a magnetic field around 1T parallel to the blood flow inside the arm. The subject's blood pressure will be lowered. The subject needs to come back to check the blood pressure 24 hours after the treatment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The systolic blood pressure in a range of 140-180 mmHg or diastolic blood pressure in a range 90-120 mmHg.
Key exclusion criteria (5 listed)
- Subjects with a pacemaker or other metallic devices implanted.
- Adults unable to consent,
- Cognitively impaired adults,
- Pregnant women,
- Prisoners.
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 |
|---|---|---|
| Magnetic field treatmentThe MBPL device for clinical trials is made with modification of an electromagnet: A bore of 10cm diameter was made to go through the frame and poles. The device can produce a magnetic field close to 1.0 T inside the bore, which is along the axis direction. The trial for each subject takes about 20-30 minutes. To start with, the subject's blood pressure is measured first as the baseline. Afterwards, the subject places his/her right arm into the bore of the electromagnet for treatment while the blood pressure is monitored with the left arm. The magnetic treatment lasts about 15 minutes and will lower the subject's blood pressure. In order to see how long the effect lasts, the subject needs to return and measure the blood pressure again 24 hours after the treatment. The clinical trials are non-invasive. There is no medicine or surgery involved. | Device | Magnetic field treatment |
Primary outcome
Change of Blood Pressure at the End of Magnetic Treatment
Time frame: Through study completion, an average of 1 year
Measure and evaluate the change of both systolic blood pressure and diastolic blood pressure from the baseline at the end of magnetic treatment.
1 secondary outcome
Change of Blood Pressure 24 Hours after the Magnetic Treatment
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2018.
- Results publication: PubMed 21867211Tao R, Huang K. Reducing blood viscosity with magnetic fields. Phys Rev E Stat Nonlin Soft Matter Phys. 2011 Jul;84(1 Pt 1):011905. doi: 10.1103/PhysRevE.84.011905. Epub 2011 Jul 12.
- Results publicationTao R, Tang H, Xu X, Tawhid-Al-Islam K, Du E, "Systems and methods for reducing the viscosity of blood, suppressing turbulence in blood circulation, and curing rouleaux" PCT/US2017/059446, WO2018/085330A4
- Special ReportLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Rongjia Tao, Ph.D. principal investigator
Cardiovascular Therapy LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic field treatment in people with Hypertension, run by Cardiovascular Therapy LLC at 1 site in United States.
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 5 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 20 Dec 2018. 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 United States. 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. 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 Rongjia Tao, Ph.D. (2152047651, rtao@temple.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Blood Pressure at the End of Magnetic Treatment (time frame: Through study completion, an average of 1 year). 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 NCT03783117, which also lists 2 linked publications.
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 20 Dec 2018.