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Clinical Trials/ACTRN12615000780550
ACTRN12615000780550
Terminated
未知

Effect of a sound wave vibration intervention on heart rate and blood pressure after triggering the sympathetic nervous system in healthy controls, healthy participants with elevated sympathetic activity and participants with early to mild hypertension.

Monash Health0 sites50 target enrollmentJuly 28, 2015

Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
Monash Health
Enrollment
50
Status
Terminated
Last Updated
6 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 28, 2015
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • 1\. Between the ages of 18 and 50 years
  • 2\. Competent and willing to provide written, informed consent to participate in the study
  • Normal, healthy controls:
  • 1\. Free of any comorbidities
  • Healthy with elevated sympathetic activity:
  • 1\. Free of any comorbidities
  • 2\. Naturally high resting heart rate
  • 3\. May have previously been diagnosed with an anxiety disorder
  • Early to mild hypertension:
  • 1\. Documented diagnosis and treatment of hypertension within the last six months

Exclusion Criteria

  • 1\. Previous renal denervation or carotid barostimulation implant
  • 2\. History of a clavicle fracture as an adult (over 18 years)
  • 3\. Haemodynamically significant valvular heart disease for which, in the opinion of the Investigator, a significant reduction of BP is contraindicated
  • 4\.History of an implanted cardiac (e.g., implantable cardioverter\-defibrillator, pacemaker, cardiac resynchronisation therapy) or neurostimulation device
  • 5\. History of having undergone any type of cardiac surgery including coronary artery bypass graft and/or valve surgery
  • 6\. History of stent grafting
  • 7\. Known secondary causes of hypertension or primary pulmonary hypertension
  • 8\. Prior surgery or radiation to the area of the carotid sinus, or presence of a stent or other implant in the carotid artery
  • 9\. Known or suspected baroreflex failure or significant orthostatic hypotension (one or more episodes in the past year not related to medications. Defined as reduction in SBP of equal to or more than 20mmHg or diastolic blood pressure (DBP) equal to or more than 10 mmHg within three minutes of standing).
  • 10\. One or more hospital admissions for a hypertensive crisis within the past year. Hypertensive crisis is defined as severely elevated BP \[greater than 180/110 mmHg] that is not related to confirmed non\-adherence with medications, together with progressive or impending target organ damage, requiring hospitalization and typically admission to the intensive care unit

Outcomes

Primary Outcomes

Not specified

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