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Completed

NCT Number: NCT00709930

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

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

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Key information

Conditions

Essential Hypertension Cardiovascular Diseases Hypertension Vascular Diseases

Age range

20 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Kyoto University Hospital

Kyoto, 606-8507, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnetic field generator

Device

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

Placebo magnetic field generator

Device

Placebo device with no magnetic fields

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).

    Time frame: baseline and the end of the exposure regimen (the average of the pre-exposure values for the last two sessions)

Secondary outcomes

  1. 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)

    Time frame: baseline and the end of the exposure regimen (the average of the pre-exposure values for the last two sessions)

  2. The change in both SBP and DBP values between pre-exposure and post-exposure for each session (averaged over the regimen)

    Time frame: for each session

  3. The incidence of adverse events

    Time frame: during exposure and at the end of the exposure period and at six months after exposure

Sponsors and collaborators

Lead sponsor

Kyoto University

Other

Registry information

Official study title

Randomized Placebo-Controlled Trial of Efficacy and Safety of Weak Extremely Low Frequency Electromagnetic Field in Mild and Moderate Essential Hypertension

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jul 3, 2008
Registry last updated
Mar 31, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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