Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02250495




Registration number
NCT02250495
Ethics application status
Date submitted
20/09/2014
Date registered
26/09/2014
Date last updated
14/09/2015

Titles & IDs
Public title
The Sympara VIBE Study for Hypertension
Scientific title
VIBE: A Clinical Study to Evaluate the Sympara Therapeutic System for the Treatment of Hypertension
Secondary ID [1] 0 0
STS1402
Universal Trial Number (UTN)
Trial acronym
VIBE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Sympara Therapeutic System

Experimental: Sympara Therapeutic System - All subjects will wear for the Sympara device for 30 days


Treatment: Devices: Sympara Therapeutic System
Sympara Therapeutic System as a non-invasive, fully reversible alternative for the treatment of hypertension
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of subjects with serious, device-related adverse events as a measure of safety and tolerability
Timepoint [1] 0 0
30 days
Secondary outcome [1] 0 0
Number of subjects with a reduction in baseline blood pressure following 30 days of Sympara device use as a measure of efficacy
Timepoint [1] 0 0
30 days

Eligibility
Key inclusion criteria
- 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
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1/Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2016
Actual
Sample size
Target
Accrual to date
Final
8
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [2] 0 0
Monash Health - Clayton
Recruitment hospital [3] 0 0
Barwon Health - Geelong
Recruitment postcode(s) [1] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
3220 - Geelong

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sympara Medical, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT02250495
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ian Meredith, AM, PhD
Address 0 0
Monash Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02250495