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IntErnational Long-term Follow-up Study of Patients With Uncontrolled HyperTensioN (EnligHTN-II)

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ClinicalTrials.gov Identifier: NCT01705080
Recruitment Status : Active, not recruiting
First Posted : October 12, 2012
Results First Posted : September 14, 2018
Last Update Posted : September 14, 2018
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Brief Summary:
The purpose of this post market clinical investigation is to further evaluate the safety and performance of the EnligHTN™ Renal Denervation System in the treatment of patients with uncontrolled hypertension.

Condition or disease Intervention/treatment
Hypertension Blood Pressure Device: EnligHTN

Detailed Description:
This is a post market, prospective, multicenter, non-randomized, single arm study of the EnligHTN™ Renal Denervation System. Approximately 500 subjects with uncontrolled hypertension will undergo renal artery ablation at approximately 40 investigational sites located internationally and will be followed up to five (5) years post procedure.

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Study Type : Observational
Actual Enrollment : 354 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: IntErnational Non-randomized, Single-arm, Long-term Follow-up Study of Patients With Uncontrolled HyperTensioN
Actual Study Start Date : January 2013
Actual Primary Completion Date : December 2016
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
A - EnligHTN for Severe Resistant HTN
  • Office systolic Blood Pressure ≥160 mmHg
  • Subject is taking ≥3 anti-hypertensive medications (including 1 diuretic), or subject has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.
  • Patient has an estimated GFR ≥45 mL/min per 1.73 m2 using the Modification of Diet in Renal Disease (MDRD) formula
Device: EnligHTN
Renal artery ablation with EnligHTN system used for all groups

B - EnligHTN for Resistant HTN
  • Office systolic Blood Pressure ≥140 mmHg
  • Subject is taking ≥3 anti-hypertensive medications (including 1 diuretic), or subject has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.
  • Patient has an estimated GFR ≥45 mL/min per 1.73 m2 using the Modification of Diet in Renal Disease (MDRD) formula
Device: EnligHTN
Renal artery ablation with EnligHTN system used for all groups

C - EnligHTN for Resistant HTN & CKD
  • Office systolic Blood Pressure ≥140 mmHg
  • Subject is taking ≥3 anti-hypertensive medications (including 1 diuretic), or subject has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.
  • Patient has an estimated ≥15 GFR <45 mL/min per 1.73 m2 using the Modification of Diet in Renal Disease (MDRD) formula
Device: EnligHTN
Renal artery ablation with EnligHTN system used for all groups




Primary Outcome Measures :
  1. Mean Reduction in Office Systolic Blood Pressure at Six (6) Months Across All Subjects Post Renal Denervation and Within Sub-groups [ Time Frame: 6 months post procedure ]
    Mean reduction in office systolic blood pressure at six (6) months from baseline.


Secondary Outcome Measures :
  1. Percent of Patients Who Experience a Procedural Related Event [ Time Frame: 30 days post procedure ]
  2. Assessment of Renovascular Safety as Measured by New Renal Artery Stenosis or Aneurysm at the Site of Ablation [ Time Frame: 6 months, 2 years, and 5 years post procedure ]
  3. Renal Function Change Based on eGFR [ Time Frame: 6 months, 2 years, and 5 years post procedure ]
  4. Change in Ambulatory Blood Pressure Parameters at 6 Months [ Time Frame: 6 months post procedure ]
  5. Change in Office Diastolic Blood Pressure at 6 Months [ Time Frame: 6 months post procedure ]
  6. Percentage of Subjects Achieving Office Systolic Blood Pressure < 140 at 6 Month Visit [ Time Frame: 6 months post procedure ]
  7. Change in Office Blood Pressure Parameters at 12, 24, 36, 48, 60 Months Post Denervation [ Time Frame: 12, 24, 36, 48, 60 months post procedure ]
  8. Change in Ambulatory Blood Pressure Parameters at 12, 24, 36, 48, 60 Months Post Denervation [ Time Frame: 12, 24, 36, 48, 60 months post procedure ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects with uncontrolled hypertension
Criteria

Inclusion Criteria:

  • Subject is ≥ 18 years of age at time of consent
  • 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 office Systolic Blood Pressure ≥ 140 mmHg at confirmatory visit
  • Subject has a daytime mean Systolic Ambulatory Blood Pressure > 135 mmHg within 90 days prior to procedure
  • Subject has established hypertension (diagnosed ≥12 month prior to baseline) and on a guideline based drug regimen at a stable and fully tolerated dose consisting of ≥ 3 anti-hypertensive medications (including 1 diuretic) or subject has a documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.

Exclusion Criteria:

  • Subject has significant renovascular abnormalities such as renal artery stenosis > 30%
  • Subject has undergone prior renal angioplasty, renal denervation, indwelling renal stents, and/or abdominal aortic stent grafts
  • Subject has hemodynamically significant valvular heart disease as determined by study investigator
  • Subject has a life expectancy less than 12 months, as determined by the Investigator
  • Subject is participating in another clinical study which has the potential to impact their hypertension management (pharmaceutical/device/homeopathic)
  • Subject is pregnant, nursing, or of childbearing potential and is not using adequate contraceptive methods
  • Subject has active systemic infection
  • Subject has renal arteries with diameter(s) < 4 mm in diameter
  • Subject has an estimated GFR <15 mL/min per 1.73 m2 using the Modification of Diet in Renal Disease (MDRD) formula
  • Subject had a renal transplant or is awaiting a renal transplant
  • Subject has blood clotting abnormalities

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01705080


  Show 35 Study Locations
Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Principal Investigator: Melvin Lobo, MD NIHR Barts Cardiovascular Biomedical Research Unit
Principal Investigator: Stephen Worthley, MD Royal Adelaide Hospital

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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT01705080     History of Changes
Other Study ID Numbers: 1201
First Posted: October 12, 2012    Key Record Dates
Results First Posted: September 14, 2018
Last Update Posted: September 14, 2018
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Abbott Medical Devices:
Renal Denervation
Renal artery
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases