- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01903187
EnligHTN IV Trial - Multicenter Sham-controlled RCT of Renal Denervation for Hypertension (EnligHTN-IV)
Multi-center, Randomized, Single-blind, Sham Controlled Clinical Investigation of Renal Denervation for Uncontrolled Hypertension
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Alabama
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Huntsville, Alabama, United States, 35801
- Heart Center Research, LLC
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Arkansas
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Little Rock, Arkansas, United States, 72211
- Arkansas Heart Hospital
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Mississippi
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Jackson, Mississippi, United States, 39216
- Jackson Heart Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Renal Denervation
Renal artery ablation with the EnligHTN™ Renal Denervation System.
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Renal artery angiogram plus bilateral renal denervation with the EnligHTN renal denervation system
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Active Comparator: Sham procedure
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Renal artery angiogram
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
Time Frame: 6 months post randomization
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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
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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
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6 months post randomization
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Device or Procedure Related Adverse Events by Severity Post Randomization Through Six (6) Months
Time Frame: 6 months post randomization
|
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.
|
6 months post randomization
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The Number of Subjects That Experience Each Type of MAE
Time Frame: 6 months post randomization
|
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.
|
6 months post randomization
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Incidence of Achieving ≥ 10 mmHg, ≥ 15 mmHg, and ≥20 mmHg Reductions in OSBP
Time Frame: 6 months post randomization, and all follow-up timepoints
|
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.
|
6 months post randomization, and all follow-up timepoints
|
Reduction in Ambulatory Blood Pressure (ABP) Parameters
Time Frame: baseline, 6 months post randomization, and all follow-up timepoints
|
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.
|
baseline, 6 months post randomization, and all follow-up timepoints
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: William B White, MD, UConn Health
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1204
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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