Efficacy and Safety of Weak Extremely Low Frequency Electromagnetic Fields in Mild and Moderate Essential Hypertension

Phase 2

Completed

• Conditions: Essential Hypertension
• Interventions: Device: Magnetic field generator; Device: Placebo magnetic field generator

• Registration Number: NCT00709930
• Lead Sponsor: Kyoto University

Brief Summary

This study will evaluate the efficacy and safety of weak extremely low frequency electromagnetic fields (ELF-EMF) in mild and moderate essential hypertension.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2008-06-27
• Study First Submitted QC: 2008-07-01
• Study First Posted: 2008-07-03
• Primary Completion: 2008-08
• Study Completion: 2008-12
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-30
• Last Update Posted: 2009-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Ages: 20 years to 74 years
• Genders : Both
• The severity of hypertension: mild and moderate (WHO/ISH criteria stage I-II) Systolic blood pressure (SBP) >/= 140 and/or diastolic blood pressure (DBP)>/= 90 (untreated hypertension cases)

Exclusion Criteria

• Any of the following medical conditions:
• Severe essential hypertension (DBP >110)
• Secondary or malignant hypertension
• History or symptoms of cerebral vascular disease
• History of myocardial infarction
• History of angina pectoris, atrial fibrillation, heart failure and arrhythmia
• Renal dysfunction (serum creatinine > 2.1mg/dl)
• Severe hepatic dysfunction
• Uncontrolled diabetes
• Allergy, drug sensitivity or chronic skin disease
• Peptic ulcer disease
• Current pregnancy or lactation
• Depression that needs to be treated
• Hypertension controlled with antihypertensive medication

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1,Exposed to ELF-EMF	Magnetic field generator	Device: Magnetic field generator Exposure to 1-μT 8/6-Hz ELF-EMF
2,Placebo	Placebo magnetic field generator	Device: Placebo device with no magnetic fields

Primary Outcome Measures

Name	Time	Method
The difference between the ELF-EMF and sham groups with respect to the absolute change in SBP value between baseline and the end of the exposure regimen (the age of the pre-exposure values for the last two sessions).	baseline and the end of the exposure regimen (the average of the pre-exposure values for the last two sessions)

Secondary Outcome Measures

Name	Time	Method
The difference between the ELF-EMF and sham groups with respect to the change in DBP value between baseline and the end of the exposure regimen (the average of the pre-exposure values for the last two sessions)	baseline and the end of the exposure regimen (the average of the pre-exposure values for the last two sessions)
The change in both SBP and DBP values between pre-exposure and post-exposure for each session (averaged over the regimen)	for each session
The incidence of adverse events	during exposure and at the end of the exposure period and at six months after exposure

Trial Locations

Locations (1)

Kyoto University Hospital; 🇯🇵 Kyoto, Japan