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The Sympara VIBE Study for Hypertension (VIBE)

Primary Purpose

Hypertension

Status
Terminated
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
Sympara Therapeutic System
Sponsored by
Sympara Medical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

Sites / Locations

  • Princess Alexandra Hospital
  • Monash Health
  • Barwon Health

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sympara Therapeutic System

Arm Description

All subjects will wear for the Sympara device for 30 days

Outcomes

Primary Outcome Measures

Number of subjects with serious, device-related adverse events as a measure of safety and tolerability

Secondary Outcome Measures

Number of subjects with a reduction in baseline blood pressure following 30 days of Sympara device use as a measure of efficacy
Evaluating change in office, home and ambulatory blood pressure measurements at 30 days compared to baseline

Full Information

First Posted
September 20, 2014
Last Updated
September 11, 2015
Sponsor
Sympara Medical, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02250495
Brief Title
The Sympara VIBE Study for Hypertension
Acronym
VIBE
Official Title
VIBE: A Clinical Study to Evaluate the Sympara Therapeutic System for the Treatment of Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Terminated
Why Stopped
Company closed
Study Start Date
October 2014 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
January 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sympara Medical, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sympara Therapeutic System
Arm Type
Experimental
Arm Description
All subjects will wear for the Sympara device for 30 days
Intervention Type
Device
Intervention Name(s)
Sympara Therapeutic System
Intervention Description
Sympara Therapeutic System as a non-invasive, fully reversible alternative for the treatment of hypertension
Primary Outcome Measure Information:
Title
Number of subjects with serious, device-related adverse events as a measure of safety and tolerability
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Number of subjects with a reduction in baseline blood pressure following 30 days of Sympara device use as a measure of efficacy
Description
Evaluating change in office, home and ambulatory blood pressure measurements at 30 days compared to baseline
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ian Meredith, AM, PhD
Organizational Affiliation
Monash Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Monash Health
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Barwon Health
City
Geelong
State/Province
Victoria
ZIP/Postal Code
3220
Country
Australia

12. IPD Sharing Statement

Learn more about this trial

The Sympara VIBE Study for Hypertension

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