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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01705080




Registration number
NCT01705080
Ethics application status
Date submitted
19/09/2012
Date registered
12/10/2012
Date last updated
27/05/2021

Titles & IDs
Public title
IntErnational Long-term Follow-up Study of Patients With Uncontrolled HyperTensioN
Scientific title
IntErnational Non-randomized, Single-arm, Long-term Follow-up Study of Patients With Uncontrolled HyperTensioN
Secondary ID [1] 0 0
1201
Universal Trial Number (UTN)
Trial acronym
EnligHTN-II
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension 0 0
Blood Pressure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - EnligHTN

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 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula

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 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula

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 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula


Treatment: Devices: EnligHTN
Renal artery ablation with EnligHTN system used for all groups
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean Reduction in Office Systolic Blood Pressure From Baseline to 6 Months
Timepoint [1] 0 0
Baseline to 6 months
Secondary outcome [1] 0 0
Acute Safety: Percentage of Participants With Peri-procedural Events Within 30 Days Post-procedure
Timepoint [1] 0 0
30 days post procedure
Secondary outcome [2] 0 0
Midterm Safety: Percentage of Participants With New Renal Artery Stenosis and/or Aneurysm at Ablation Site at 6 Months
Timepoint [2] 0 0
6 months
Secondary outcome [3] 0 0
Midterm Safety: Mean Change in eGFR (mL/Min/1.73m²) From Confirmatory Visit to 6 Months
Timepoint [3] 0 0
Confirmatory visit to 6 months
Secondary outcome [4] 0 0
Long Term Safety: Percentage of Participants With New Renal Artery Stenosis and/or Aneurysm at Ablation Site at 2 Years
Timepoint [4] 0 0
2 years
Secondary outcome [5] 0 0
Long Term Safety: Percentage of Participants With New Renal Artery Stenosis and/or Aneurysm at Ablation Site at 5 Years
Timepoint [5] 0 0
5 years
Secondary outcome [6] 0 0
Long Term Safety: Mean Change in eGFR (mL/Min/1.73m²) From Confirmatory Visit to 2 Years
Timepoint [6] 0 0
Confirmatory visit to 2 years
Secondary outcome [7] 0 0
Long Term Safety: Mean Change in eGFR (mL/Min/1.73m²) From Confirmatory Visit to 5 Years
Timepoint [7] 0 0
Confirmatory visit to 5 years
Secondary outcome [8] 0 0
Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 6 Months
Timepoint [8] 0 0
Baseline to 6 months
Secondary outcome [9] 0 0
Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 6 Months
Timepoint [9] 0 0
Baseline to 6 months
Secondary outcome [10] 0 0
Mean Change in Office Diastolic Blood Pressure From Baseline to 6 Months
Timepoint [10] 0 0
Baseline to 6 months
Secondary outcome [11] 0 0
Percentage of Participants Achieved Office Systolic Blood Pressure < 140 mmHg at 6 Months
Timepoint [11] 0 0
6 months
Secondary outcome [12] 0 0
Mean Change in Office Systolic Blood Pressure From Baseline to 1 Year Post Denervation
Timepoint [12] 0 0
Baseline to 1 year
Secondary outcome [13] 0 0
Mean Change in Office Systolic Blood Pressure From Baseline to 2 Years Post Denervation
Timepoint [13] 0 0
Baseline to 2 years
Secondary outcome [14] 0 0
Mean Change in Office Systolic Blood Pressure From Baseline to 3 Years Post Denervation
Timepoint [14] 0 0
Baseline to 3 years
Secondary outcome [15] 0 0
Mean Change in Office Systolic Blood Pressure From Baseline to 4 Years Post Denervation
Timepoint [15] 0 0
Baseline to 4 years
Secondary outcome [16] 0 0
Mean Change in Office Systolic Blood Pressure From Baseline to 5 Years Post Denervation
Timepoint [16] 0 0
Baseline to 5 years
Secondary outcome [17] 0 0
Mean Change in Office Diastolic Blood Pressure From Baseline to 1 Year Post Denervation
Timepoint [17] 0 0
Baseline to 1 year
Secondary outcome [18] 0 0
Mean Change in Office Diastolic Blood Pressure From Baseline to 2 Years Post Denervation
Timepoint [18] 0 0
Baseline to 2 years
Secondary outcome [19] 0 0
Mean Change in Office Diastolic Blood Pressure From Baseline to 3 Years Post Denervation
Timepoint [19] 0 0
Baseline to 3 years
Secondary outcome [20] 0 0
Mean Change in Office Diastolic Blood Pressure From Baseline to 4 Years Post Denervation
Timepoint [20] 0 0
Baseline to 4 years
Secondary outcome [21] 0 0
Mean Change in Office Diastolic Blood Pressure From Baseline to 5 Years Post Denervation
Timepoint [21] 0 0
Baseline to 5 years
Secondary outcome [22] 0 0
Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 1 Year Post Denervation
Timepoint [22] 0 0
Baseline to 1 year
Secondary outcome [23] 0 0
Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 2 Years Post Denervation
Timepoint [23] 0 0
Baseline to 2 years
Secondary outcome [24] 0 0
Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 3 Years Post Denervation
Timepoint [24] 0 0
Baseline to 3 years
Secondary outcome [25] 0 0
Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 4 Years Post Denervation
Timepoint [25] 0 0
Baseline to 4 years
Secondary outcome [26] 0 0
Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 5 Years Post Denervation
Timepoint [26] 0 0
Baseline to 5 years
Secondary outcome [27] 0 0
Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 1 Year Post Denervation
Timepoint [27] 0 0
Baseline to 1 year
Secondary outcome [28] 0 0
Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 2 Years Post Denervation
Timepoint [28] 0 0
Baseline to 2 years
Secondary outcome [29] 0 0
Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 3 Years Post Denervation
Timepoint [29] 0 0
Baseline to 3 years
Secondary outcome [30] 0 0
Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 4 Years Post Denervation
Timepoint [30] 0 0
Baseline to 4 years
Secondary outcome [31] 0 0
Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 5 Years Post Denervation
Timepoint [31] 0 0
Baseline to 5 years

Eligibility
Key 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 is 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 m^2 using the MDRD formula
* Subject had a renal transplant or is awaiting a renal transplant
* Subject has blood clotting abnormalities

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/01/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
27/11/2019
Sample size
Target
Accrual to date
Final
276
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
The Prince Charles Hospital - Chermside
Recruitment hospital [3] 0 0
Royal Melbourne Hospital - City Campus - Parkville
Recruitment hospital [4] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
4032 - Chermside
Recruitment postcode(s) [3] 0 0
3050 - Parkville
Recruitment postcode(s) [4] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
France
State/province [1] 0 0
Franche-Comte
Country [2] 0 0
France
State/province [2] 0 0
Massy
Country [3] 0 0
France
State/province [3] 0 0
Lyon
Country [4] 0 0
France
State/province [4] 0 0
St. Etienne
Country [5] 0 0
France
State/province [5] 0 0
Strasbourg
Country [6] 0 0
Germany
State/province [6] 0 0
Bavaria
Country [7] 0 0
Germany
State/province [7] 0 0
Hesse
Country [8] 0 0
Germany
State/province [8] 0 0
Nordrhein Westfalen
Country [9] 0 0
Germany
State/province [9] 0 0
Saxony
Country [10] 0 0
Germany
State/province [10] 0 0
Bad Krozingen
Country [11] 0 0
Germany
State/province [11] 0 0
Berlin
Country [12] 0 0
Germany
State/province [12] 0 0
Essen
Country [13] 0 0
Germany
State/province [13] 0 0
Homburg
Country [14] 0 0
Germany
State/province [14] 0 0
Mainz
Country [15] 0 0
Germany
State/province [15] 0 0
Trier
Country [16] 0 0
Greece
State/province [16] 0 0
Athens
Country [17] 0 0
Italy
State/province [17] 0 0
Tuscany
Country [18] 0 0
Italy
State/province [18] 0 0
Bologna
Country [19] 0 0
Italy
State/province [19] 0 0
Milano
Country [20] 0 0
Netherlands
State/province [20] 0 0
Den Haag
Country [21] 0 0
Netherlands
State/province [21] 0 0
Utrecht
Country [22] 0 0
New Zealand
State/province [22] 0 0
Dunedin
Country [23] 0 0
Norway
State/province [23] 0 0
Bergen
Country [24] 0 0
Norway
State/province [24] 0 0
Trondheim
Country [25] 0 0
Spain
State/province [25] 0 0
Basque
Country [26] 0 0
Sweden
State/province [26] 0 0
Goteborg
Country [27] 0 0
United Kingdom
State/province [27] 0 0
London
Country [28] 0 0
United Kingdom
State/province [28] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Abbott Medical Devices
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01705080
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Melvin Lobo, MBChB PhD
Address 0 0
NIHR Barts Cardiovascular Biomedical Research Unit
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01705080