Multi-center, Randomized, Single-blind, Sham Controlled Clinical Investigation of Renal Denervation for Uncontrolled Hypertension (EnligHTN IV)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01903187
First received: July 9, 2013
Last updated: December 20, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Drug-resistant Uncontrolled Hypertension
Device: EnligHTN Renal Denervation
Other: Sham

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

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). [ Time Frame: 6 months post randomization ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Device or Procedure related adverse events by severity post randomization through six (6) months [ Time Frame: 6 months post randomization ] [ Designated as safety issue: Yes ]
  • The number of subjects that experience each type of MAE [ Time Frame: 6 months post randomization ] [ Designated as safety issue: Yes ]
  • Incidence of achieving ≥ 10 mmHg, ≥ 15 mmHg, and ≥20 mmHg reductions in OSBP [ Time Frame: 6 months post randomization, and all follow-up timepoints ] [ Designated as safety issue: No ]
  • Reduction in Ambulatory Blood Pressure (ABP) parameters [ Time Frame: baseline, 6 months post randomization, and all follow-up timepoints ] [ Designated as safety issue: No ]

Estimated Enrollment: 590
Study Start Date: October 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Renal Denervation
Renal artery ablation with the EnligHTN™ Renal Denervation System.
Device: EnligHTN Renal Denervation
Active Comparator: Sham procedure
Sham procedure
Other: Sham

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 Modified of Diet in Renal Disease (MDRD) formula
  • Subject has evidence of significant abdominal aortic aneurysm (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 prior to enrollment
  • Subject has a condition which would interfere with the accurate interpretation of the study endpoints including but not limited to orthostatic hypotension, chronic oxygen support other than for sleep apnea, primary pulmonary hypertension, Type I Diabetes Mellitus, pheochromocytoma, Cushing's disease, coarctation of the aorta, hyperthyroidism, or hyperparathyroidism, large arm diameter that is unable to accommodate the blood pressure cuff, arrhythmia that interferes with automatic pulse sensing.
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01903187

Locations
United States, Alabama
Heart Center Research, LLC
Huntsville, Alabama, United States, 35801
United States, Arkansas
Arkansas Heart Hospital
Little Rock, Arkansas, United States, 72211
United States, Mississippi
Jackson Heart Clinic
Jackson, Mississippi, United States, 39216
Sponsors and Collaborators
St. Jude Medical
  More Information

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01903187     History of Changes
Other Study ID Numbers: 1204
Study First Received: July 9, 2013
Last Updated: December 20, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014