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

NCT00709930 | Completed Phase 2 DMC

• 1 other identifier: MF-II-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Essential Hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

1,Exposed to ELF-EMF

ACTIVE COMPARATOR

Device: Magnetic field generator Exposure to 1-μT 8/6-Hz ELF-EMF

Device: Magnetic field generator

2,Placebo

PLACEBO COMPARATOR

Device: Placebo device with no magnetic fields

Device: Placebo magnetic field generator

Interventions

Magnetic field generator DEVICE

dosage:Magnetic field generator Exposure to 1-μT 8/6-Hz ELF-EMF frequency:10min/day duration:1 month

1,Exposed to ELF-EMF

Placebo magnetic field generator DEVICE

Placebo device with no magnetic fields

2,Placebo

Eligibility Criteria

• Age: 20 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Kyoto University: lead

Study Sites (1)

Kyoto University Hospital

Kyoto, Kyoto, 606-8507, Japan

Location

MeSH Terms

Conditions

Essential Hypertension

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Masanori Fukushima

  Kyoto University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 27, 2008
• First Posted: July 3, 2008
• Study Start: December 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: December 1, 2008
• Last Updated: March 31, 2009

Record last verified: 2009-03

Locations

JP (1)