Clinical trial NCT01903187: EnligHTN IV Trial - Multicenter Sham-controlled RCT of Renal Denervation for Hypertension
Official title: Multi-center, Randomized, Single-blind, Sham Controlled Clinical Investigation of Renal Denervation for Uncontrolled Hypertension
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hypertension
Keywords: hypertension
resistant hypertension
renal denervation
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2013-07-19
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the EnligHTN IV clinical investigation is to demonstrate the safety and effectiveness of the EnligHTN™ Renal Denervation System in the treatment of subjects with drug-resistant uncontrolled hypertension.

Detailed description: The study enrollment was terminated early by the sponsor. This was not related to any safety issue. At the time enrollment was halted, only 2 treatment group randomizations had occurred, and sham group subjects were exited after their 1 month follow up visit.

Subject randomized to the treatment group will be followed up for three years post procedure.

Eligibility criteria: Inclusion Criteria:

* Subject is ≥18 years of age and ≤ 80 years of age at time of informed consent for participation in the clinical investigation
* Subject must be able and willing to provide written informed consent
* Subject must be able and willing to comply with the required follow-up schedule
* Subject has an office Systolic Blood Pressure ≥ 160 mmHg based on an average of 3 Blood Pressure readings at the confirmatory visit (except for subjects with Diabetes Mellitus Type II who must demonstrate an office Systolic Blood Pressure of ≥ 150 mmHg)
* Subject has a daytime mean Systolic 24-hour Ambulatory Blood Pressure value of ≥ 140 mmHg as measured during the two week screening period and confirmed at the confirmatory visit
* Subject is taking ≥ 3 antihypertensive medications concurrently at full tolerated doses (this must include one diuretic) or subject is taking a diuretic and has a documented intolerance to at least two (2) out of the three (3) remaining major classes of anti-hypertensives (ACE / ARB, Calcium Channel Blockers, Beta blockers and is unable to take 3 anti-hypertensive drugs)

  o Intolerance is defined as an absolute contraindication to an anti-hypertensive medication according to the approved labeling or an inability to take an anti-hypertensive medication as prescribed due to an adverse drug effect including an immune mediated response or interaction with other medications.
* Subjects must be on a stable antihypertensive medication regimen for a minimum of 2 weeks prior to completing the initial screening visit and the medication regimen must remain unchanged during the 2 week screening period following signing consent. Subject must be assessed at the confirmatory visit with no expected changes for at least six (6) months

Exclusion Criteria:

* Subject has had a previous renal denervation attempt
* Subject has known cause of secondary hypertension other than sleep apnea
* Subjects with significant renovascular abnormalities such as renal artery stenosis \>30%, previous renal stenting or angioplasty, renal artery occlusion, renal vein thrombosis, renal aneurysm or renal atheroembolism
* Subject has had a myocardial infarction, unstable angina pectoris, or cerebrovascular accident \< 180 days prior to enrollment
* Subject has hemodynamically significant valvular heart disease as determined by a Study Investigator
* Subject is expected to have any cardiovascular intervention within 180 days of enrollment
* Subject has blood clotting abnormalities such as thrombocytopenia, hemophilia, or significant anemia
* Subject life expectancy is \< 12 months, as determined by a Study Investigator
* Subject is participating in another Clinical Investigation (IND or IDE)
* Subject is pregnant, nursing, or of childbearing potential and is not using adequate contraceptive methods
* Subject has active systemic infection as determined by a Study Investigator
* Subject has main renal arteries with diameter(s) \< 4 mm in diameter or \< 20 mm in length or multiple renal arteries where the main renal arteries supply \<75% of the kidney
* Subject has eGFR \< 45 mL/min per 1.73 m2 using the MDRD formula
* Subject has evidence of significant AAA defined as an aneurysm size of ≥5.0 cm in width and/or involving the renal arteries, and/or requiring surgical or percutaneous intervention within 6 months of enrollment.
* Subject has had \>1 in-patient hospitalization for a hypertensive crisis within 12 months
* Subject has a condition which would interfere with the accurate interpretation of the study endpoints
* Any condition that would prohibit or interfere with the ability to obtain accurate Blood Pressure measurements using the CIP specific automatic Blood Pressure monitor
* Subject has Systolic Blood Pressure values which are greater than 20mmHg apart after six (6) measurements as assessed at the confirmatory visit

Primary outcomes:
measure: The Primary Safety Endpoint Will be the Proportion of Subjects Who Experience Any Major Adverse Event (MAE) as Adjudicated by the Clinical Event Committee (CEC).
timeFrame: 6 months post randomization
measure: The Primary Effectiveness Endpoint is the Reduction of Office Systolic Blood Pressure (OSBP) at Six (6) Months Post Randomization Compared to Baseline Between Groups
timeFrame: 6 months post randomization
Secondary outcomes:
measure: Device or Procedure Related Adverse Events by Severity Post Randomization Through Six (6) Months
timeFrame: 6 months post randomization
measure: The Number of Subjects That Experience Each Type of MAE
timeFrame: 6 months post randomization
measure: Incidence of Achieving ≥ 10 mmHg, ≥ 15 mmHg, and ≥20 mmHg Reductions in OSBP
timeFrame: 6 months post randomization, and all follow-up timepoints
measure: Reduction in Ambulatory Blood Pressure (ABP) Parameters
timeFrame: baseline, 6 months post randomization, and all follow-up timepoints
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Heart Center Research, LLC
state: Alabama
city: Little Rock
country: United States
facility: Arkansas Heart Hospital
state: Arkansas
city: Jackson
country: United States
facility: Jackson Heart Clinic
state: Mississippi
Study officials:
affiliation: UConn Health
name: William B White, MD
role: STUDY_CHAIR
affiliation: Columbia University
name: William A Gray, MD
role: STUDY_CHAIR
References: