Clinical trial NCT03314012: First-In-Human Study Evaluating a Novel Catheter Device in Subjects With Treatment-Resistant Hypertension
Official title: First-In-Human Study for Ultrasound Based Endovascular Carotid Body Ablation in Subjects With Treatment-Resistant Hypertension: A Safety and Feasibility Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertension,Essential
Lead sponsor: Cibiem, Inc.
Sponsor class: INDUSTRY
First posted: 2017-10-19
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The carotid body is located at the bifurcation of the internal and external carotid arteries. It is a chemoreceptor that plays a role in the sympathetic nervous system and in the development and maintenance of hypertension. Hypertension is a major cardiovascular risk factor and is associated with coronary artery disease, stroke, chronic kidney disease, and heart failure.

The objective of this study is to assess the effectiveness and safety of a catheter-based system to ablate the carotid body and reduce blood pressure (BP) in patients with resistant hypertension and to confirm sustainability of the treatment benefits long-term as seen following surgical CB removal.


Eligibility criteria: Inclusion Criteria:

* Mean office SBP ≥160 mmHg and DBP ≥90 mmHg during screen-in period
* Mean daytime systolic ABPM ≥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), with no medication changes expected for at least six (6) months post-procedure
* No change in anti-hypertensive drug prescription (dose, number of medications, or class of medication) for at least six (6) weeks prior to enrollment
* Negative pregnancy test for women of child-bearing age
* Willingness and able to comply with follow-up requirements
* Signed informed consent

Exclusion Criteria:

* Secondary causes of hypertension
* Calculated eGFR \<30mL/min/1.73m2
* History of repeated episodes of hypoglycemic unawareness
* Morbid obesity, defined as Body Mass Index \>40 kg/m2
* Severe obstructive sleep apnea (AHI \> 35/hr.)
* Pacemaker and/or implantable defibrillators
* 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

Primary outcomes:
measure: Safety as assessed by incidence of major adverse events
timeFrame: From procedure to one month post-procedure
measure: Mean reduction in 24-hour ambulatory systolic and diastolic blood pressure
timeFrame: Baseline versus six months post-procedure
Secondary outcomes:
measure: Composite rate of major adverse events
timeFrame: At 6, 12, 18, and 24 months post-procedure
measure: Mean reduction in office systolic and diastolic blood pressure, and home systolic and diastolic blood pressure
timeFrame: Baseline versus 3, 6, 12, 18, and 24 months
measure: Proportion of subjects with controlled blood pressure at 6, 12, 18, and 24 months post-procedure
timeFrame: At 6, 12, 18, and 24 months
measure: Ventricular morphometric improvements from cardiac MRI measurements
timeFrame: Screening versus 12 and 24 months
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
state: Western Australia
city: Perth
country: Australia
facility: Royal Perth Hospital
state: Western Australia
city: Prague
country: Czechia
facility: Na Homolce Hospital
city: Bad Krozingen
country: Germany
facility: Clinic Cardiology and Angiology II
city: Frankfurt
country: Germany
facility: Cardiovascular Center Frankfurt (CVC Frankfurt)
city: Homburg
country: Germany
facility: Klinik für Innere Medizin III
Study officials:
affiliation: Royal Perth Hospital
name: Markus Schlaich, Professor
role: PRINCIPAL_INVESTIGATOR
References: