EnligHTN IV Trial - Multicenter Sham-controlled RCT of Renal Denervation for Hypertension

NCT01903187 | Terminated Results DMC

• 1 other identifier: 1204
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 3

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.

Conditions

Hypertension

Keywords

hypertension; resistant hypertension; renal denervation

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  6 months post randomization

• The Primary Effectiveness Endpoint is the Reduction of Office Systolic Blood Pressure (OSBP) at Six (6) Months Post Randomization Compared to Baseline Between Groups

  6 months post randomization

Secondary Outcomes (4)

• Device or Procedure Related Adverse Events by Severity Post Randomization Through Six (6) Months

  6 months post randomization

• The Number of Subjects That Experience Each Type of MAE

  6 months post randomization

• Incidence of Achieving ≥ 10 mmHg, ≥ 15 mmHg, and ≥20 mmHg Reductions in OSBP

  6 months post randomization, and all follow-up timepoints

• Reduction in Ambulatory Blood Pressure (ABP) Parameters

  baseline, 6 months post randomization, and all follow-up timepoints

Study Arms (2)

Renal Denervation

EXPERIMENTAL

Renal artery ablation with the EnligHTN™ Renal Denervation System.

Device: EnligHTN Renal Denervation

Sham procedure

ACTIVE COMPARATOR

Sham procedure

Procedure: Sham

Interventions

EnligHTN Renal Denervation DEVICE

Renal artery angiogram plus bilateral renal denervation with the EnligHTN renal denervation system

Renal Denervation

Sham PROCEDURE

Renal artery angiogram

Sham procedure

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (3)

Heart Center Research, LLC

Huntsville, Alabama, 35801, United States

Location

Arkansas Heart Hospital

Little Rock, Arkansas, 72211, United States

Location

Jackson Heart Clinic

Jackson, Mississippi, 39216, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Limitations and Caveats

Enrollment ended early due to a sponsor decision unrelated to safety. The 2 treatment group subjects are being followed up through 3 years. The 2 sham group subjects were exited after their 1 month visit. Due to these reasons, data is limited.

Results Point of Contact

• Title: Steven Madej
• Organization: St. Jude Medical, Inc.

smadej@sjm.com

651-756-2230

Study Officials

• William B White, MD

  UConn Health

  STUDY CHAIR

• William A Gray, MD

  Columbia University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2013
• First Posted: July 19, 2013
• Study Start: October 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: November 1, 2016
• Last Updated: February 15, 2019
• Results First Posted: March 17, 2016

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)