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The Sympara VIBE Study for Hypertension
VIBE
VIBE: A Clinical Study to Evaluate the Sympara Therapeutic System for the Treatment of Hypertension
1 other identifier
interventional
8
1 country
3
Brief Summary
The purpose of the VIBE study is to evaluate the efficacy and safety of the Sympara Therapeutic System in the treatment of hypertension
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 hypertension
Started Oct 2014
Typical duration for phase_1 hypertension
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 20, 2014
CompletedFirst Posted
Study publicly available on registry
September 26, 2014
CompletedStudy Start
First participant enrolled
October 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedSeptember 14, 2015
September 1, 2015
1.2 years
September 20, 2014
September 11, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Number of subjects with serious, device-related adverse events as a measure of safety and tolerability
30 days
Secondary Outcomes (1)
Number of subjects with a reduction in baseline blood pressure following 30 days of Sympara device use as a measure of efficacy
30 days
Study Arms (1)
Sympara Therapeutic System
EXPERIMENTALAll subjects will wear for the Sympara device for 30 days
Interventions
Sympara Therapeutic System as a non-invasive, fully reversible alternative for the treatment of hypertension
Eligibility Criteria
You may qualify if:
- Office systolic blood pressure of ≥150mmHg based on an average of three (3) blood pressure reading measured at both the initial screening visit and a confirmatory screening visit OR a mean daytime systolic blood pressure ≥135mm Hg on 24-hour Ambulatory Blood Pressure Measurement
- Receiving and adhering to an appropriate anti-hypertensive treatment regimen, as prescribed by physician
- Minimum six- (6) month history of diagnosis and treatment of hypertension
You may not qualify if:
- Previous renal denervation or carotid barostimulation implant
- Secondary causes of hypertension or primary pulmonary hypertension
- Prior surgery or radiation to the area of the carotid sinus, or presence of a stent or other implant in the carotid artery
- Known or suspected baroreflex failure or significant orthostatic hypotension
- One or more hospital admissions for a hypertensive crisis within the past year
- History of myocardial infarction, fibrillation event, unstable angina pectoris, syncope, transient ischemic attach (TIA) or a cerebrovascular accident within six (6) months of the screening period, or has widespread atherosclerosis with documented intrasvascular thrombosis or unstable plaques
- Diabetes mellitus (Type 1)
- Chronic renal disease requiring dialysis
- Kidney or liver transplant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
Monash Health
Clayton, Victoria, 3168, Australia
Barwon Health
Geelong, Victoria, 3220, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ian Meredith, AM, PhD
Monash Health
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 20, 2014
First Posted
September 26, 2014
Study Start
October 1, 2014
Primary Completion
December 1, 2015
Study Completion
January 1, 2016
Last Updated
September 14, 2015
Record last verified: 2015-09