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Magneto-rheology to Lower Blood Pressure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03783117
Recruitment Status : Recruiting
First Posted : December 20, 2018
Last Update Posted : December 20, 2018
Sponsor:
Information provided by (Responsible Party):
Rongjia Tao, Cardiovascular Therapy LLC

Brief 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 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.


Condition or disease Intervention/treatment Phase
Hypertension Device: Magnetic field treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Reducing Blood Viscosity and Suppressing Turbulence With Magneto-rheology to Lower Blood Pressure
Actual Study Start Date : August 10, 2018
Estimated Primary Completion Date : August 9, 2019
Estimated Study Completion Date : August 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Magnetic field treatment
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.
Device: Magnetic field treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change of Blood Pressure 24 Hours after the 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 24 hours after the magnetic treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The systolic blood pressure in a range of 140-180 mmHg or diastolic blood pressure in a range 90-120 mmHg.

Exclusion Criteria:

  • Subjects with a pacemaker or other metallic devices implanted.
  • Adults unable to consent,
  • Cognitively impaired adults,
  • Pregnant women,
  • Prisoners.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03783117


Contacts
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Contact: Rongjia Tao, Ph.D. 2152047651 rtao@temple.edu

Locations
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United States, Pennsylvania
Magnetic Blood Pressure Lowering Device Study Recruiting
Philadelphia, Pennsylvania, United States, 19122
Contact: Rongjia Tao    215-204-7651    rtao@temple.edu   
Sponsors and Collaborators
Cardiovascular Therapy LLC
Investigators
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Principal Investigator: Rongjia Tao, Ph.D. Cardiovascular Therapy LLC
Additional Information:
Study Data/Documents: Clinical Study Report  This link exits the ClinicalTrials.gov site
After the clinical trials are completed, the clinical study report will be provided upon request via rtao@temple.edu.

Publications of Results:
Tao 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

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Responsible Party: Rongjia Tao, Chief Scientist and Chief Counsel, Cardiovascular Therapy LLC
ClinicalTrials.gov Identifier: NCT03783117    
Other Study ID Numbers: 201801
First Posted: December 20, 2018    Key Record Dates
Last Update Posted: December 20, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Rongjia Tao, Cardiovascular Therapy LLC:
Hypertension
Additional relevant MeSH terms:
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Hypertension
Hypotension
Vascular Diseases
Cardiovascular Diseases