First-in-human study evaluating a novel catheter device in subjects with treatment-resistant hypertension: a safety and feasibility study.

Recruiting

• Conditions: TREATMENT-RESISTANT HYPERTENSION; Cardiovascular - Hypertension

• Registration Number: ACTRN12615001280594
• Lead Sponsor: Cibiem Australia Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-11-24
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Mean daytime systolic ABPM equal or greater than 135 mmHg during screen-in period
Adherent to a stable drug regimen of three (3) or more anti-hypertensive medications of different classes (including one (1) diuretic, unless diuretic intolerance is documented), with no medication changes expected for at least six (6) months post-procedure
Willingness and able to comply with follow-up requirements
Signed informed consent

Exclusion Criteria

Secondary causes of hypertension
Calculated eGFR smaller than 30mL/min/1.73m2
History of transient ischemic accident or cerebrovascular accident during six (6) months prior to screening
History of acute heart failure, congestive heart failure (NYHA class III-IV), myocardial infarction, unstable angina, coronary bypass or coronary angioplasty during six (6) months prior to screening
History of ipsilateral carotid endarterectomy treatment or ipsilateral carotid artery stenting
Life expectancy of less than 12 months due to other disease

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety assessed as the combined rate of major adverse events defined as All-causes of death, Hospitalization for hypertensive crisis not related to confirmed non-adherence with anti-hypertensive medications, Any device or procedure-related serious adverse event <br>[Clinical assessment one month following the treatment procedure<br>];Composite assessment of mean reduction in 24-hour ambulatory systolic and diastolic blood pressure (ABP) at six (6) months post-treatment vs. subject baseline measured using digital automatic sphygmomanometer[24-hour ambulatory systolic and diastolic blood pressure assessment six (6) month following the treatment procedure<br>]

Secondary Outcome Measures

Name	Time	Method
The composite rate of Major Adverse Events defined as <br>All causes of death related or unrelated to the procedure/ treatment approach<br>Hospitalization for hypertensive crisis not related to confirmed non-adherence with anti-hypertensive medications confirmed after careful blood pressure determination and verification of medical treatment compliance. <br>[Clinical assessment at 6, 12, 18 and 24 months post-procedure ]