Magneto-rheology to Lower Blood Pressure

NCT03783117 | Unknown DMC FDA Device

• 1 other identifier: 201801
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

Hypertension

Outcome Measures

Primary Outcomes (1)

• 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.

  Through study completion, an average of 1 year

Secondary Outcomes (1)

• Change of Blood Pressure 24 Hours after the Magnetic Treatment

  Through study completion, an average of 1 year

Study Arms (1)

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.

Device: Magnetic field treatment

Interventions

Magnetic field treatment DEVICE

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.

Magnetic field treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cardiovascular Therapy LLC: lead

Study Sites (1)

Magnetic Blood Pressure Lowering Device Study

Philadelphia, Pennsylvania, 19122, United States

RECRUITING

Related Publications (2)

• 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.

  PMID: 21867211 RESULT

• 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

  RESULT

Related Links

• Special Report

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Rongjia Tao, Ph.D.

  Cardiovascular Therapy LLC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rongjia Tao, Ph.D.

CONTACT

2152047651; rtao@temple.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Scientist and Chief Counsel

Model Details: 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.

Study Record Dates

• First Submitted: December 18, 2018
• First Posted: December 20, 2018
• Study Start: August 10, 2018
• Primary Completion: August 9, 2019
• Study Completion: August 31, 2019
• Last Updated: December 20, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)