search
Back to results

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

Primary Purpose

Hypertension

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EnligHTN Renal Denervation
Sham
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring hypertension, resistant hypertension, renal denervation

Eligibility Criteria

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

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

Sites / Locations

  • Heart Center Research, LLC
  • Arkansas Heart Hospital
  • Jackson Heart Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Renal Denervation

Sham procedure

Arm Description

Renal artery ablation with the EnligHTN™ Renal Denervation System.

Sham procedure

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Device or Procedure Related Adverse Events by Severity Post Randomization Through Six (6) Months
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. This was not enough to conduct the analysis.
The Number of Subjects That Experience Each Type of MAE
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. This was not enough to conduct the analysis.
Incidence of Achieving ≥ 10 mmHg, ≥ 15 mmHg, and ≥20 mmHg Reductions in OSBP
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. This was not enough to conduct the analysis.
Reduction in Ambulatory Blood Pressure (ABP) Parameters
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. This was not enough to conduct the analysis.

Full Information

First Posted
July 9, 2013
Last Updated
January 31, 2019
Sponsor
Abbott Medical Devices
search

1. Study Identification

Unique Protocol Identification Number
NCT01903187
Brief Title
EnligHTN IV Trial - Multicenter Sham-controlled RCT of Renal Denervation for Hypertension
Acronym
EnligHTN-IV
Official Title
Multi-center, Randomized, Single-blind, Sham Controlled Clinical Investigation of Renal Denervation for Uncontrolled Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Terminated
Why Stopped
There were no safety or effectiveness concerns. There were concerns about completing enrollment due to a competitive device's potential approval.
Study Start Date
October 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
hypertension, resistant hypertension, renal denervation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Renal Denervation
Arm Type
Experimental
Arm Description
Renal artery ablation with the EnligHTN™ Renal Denervation System.
Arm Title
Sham procedure
Arm Type
Active Comparator
Arm Description
Sham procedure
Intervention Type
Device
Intervention Name(s)
EnligHTN Renal Denervation
Intervention Description
Renal artery angiogram plus bilateral renal denervation with the EnligHTN renal denervation system
Intervention Type
Procedure
Intervention Name(s)
Sham
Intervention Description
Renal artery angiogram
Primary Outcome Measure Information:
Title
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).
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.
Time Frame
6 months post randomization
Title
The Primary Effectiveness Endpoint is the Reduction of Office Systolic Blood Pressure (OSBP) at Six (6) Months Post Randomization Compared to Baseline Between Groups
Time Frame
6 months post randomization
Secondary Outcome Measure Information:
Title
Device or Procedure Related Adverse Events by Severity Post Randomization Through Six (6) Months
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. This was not enough to conduct the analysis.
Time Frame
6 months post randomization
Title
The Number of Subjects That Experience Each Type of MAE
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. This was not enough to conduct the analysis.
Time Frame
6 months post randomization
Title
Incidence of Achieving ≥ 10 mmHg, ≥ 15 mmHg, and ≥20 mmHg Reductions in OSBP
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. This was not enough to conduct the analysis.
Time Frame
6 months post randomization, and all follow-up timepoints
Title
Reduction in Ambulatory Blood Pressure (ABP) Parameters
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. This was not enough to conduct the analysis.
Time Frame
baseline, 6 months post randomization, and all follow-up timepoints

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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William B White, MD
Organizational Affiliation
UConn Health
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
William A Gray, MD
Organizational Affiliation
Columbia University
Official's Role
Study Chair
Facility Information:
Facility Name
Heart Center Research, LLC
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Arkansas Heart Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Jackson Heart Clinic
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs