IntErnational Long-term Follow-up Study of Patients With Uncontrolled HyperTensioN

Hypertension Clinical Trial

— EnligHTN-II  

Official title:

IntErnational Non-randomized, Single-arm, Long-term Follow-up Study of Patients With Uncontrolled HyperTensioN

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01705080
• Other study ID #: 1201
• Status: Terminated
• Start date: January 17, 2013
• Est. completion date: November 27, 2019

Study information

• Verified date: May 2021
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 years post procedure.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 276
• Est. completion date: November 27, 2019
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

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

Related Conditions & MeSH terms

• Blood Pressure
• Hypertension

Intervention

Device:
• EnligHTN
Renal artery ablation with EnligHTN system used for all groups

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	The Prince Charles Hospital	Chermside
Australia	Royal Melbourne Hospital - City Campus	Parkville
Australia	Royal Perth Hospital	Perth
France	CHU de Besancon - Jean Minjoz	Besancon	Franche-Comte
France	Hopital de la Croix Rousse	Lyon
France	Institute Cardio. Paris-Sud-Institut Jacques Cartier	Paris	Massy
France	St-Etienne CHU	St. Etienne
France	Hopital Civil - Universitaires de Strasbourg	Strasbourg
Germany	Universitats-Herzzentrum Freiburg - Bad Krozingen	Bad Krozingen
Germany	Kerckhoff-Klinik gGmbH	Bad Nauheim	Hesse
Germany	Herz-und Diabetes Zentrum NRW	Bad Oeynhausen	Nordrhein Westfalen
Germany	Jüdisches Krankenhaus Berlin	Berlin
Germany	Klinikum Coburg GmbH	Coburg	Bavaria
Germany	Universitatsklinikum Essen (AoR)	Essen
Germany	Universitatsklinikum des Saarlandes	Homburg
Germany	Klinikum Ingolstadt GmbH	Ingolstadt	Bavaria
Germany	Uni-Klinik Leipzig, Intervent. Angiologie	Leipzig	Saxony
Germany	Klinikum der Johannes-Gutenberg-Universitat	Mainz
Germany	Krankenhaus der Barmherzigen Bruder	Trier
Greece	University of Athens, Ippocration Hospital	Athens
Italy	Policlinico S.Orsola Malpighi	Bologna
Italy	Fondazione Toscana Gabriele Monasterio CNR	Massa	Tuscany
Italy	Centro Cardiologico Monzino	Milano
Netherlands	Haga Ziekenhuis Locatie Leyenburg	Den Haag
Netherlands	UMC Utrecht	Utrecht
New Zealand	Dunedin Public Hospital	Dunedin
Norway	Haukeland Universitetssykehus	Bergen
Norway	St. Olavs University Hospital	Trondheim
Spain	Hospital Universitario Donostia	San Sebastián	Basque
Sweden	Sahlgrenska University Hospital Gothenburg	Goteborg
United Kingdom	NIHR Barts Cardiovascular Biomedical Research Unit	London
United Kingdom	Northern General Hospital	Sheffield

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

Australia,  France,  Germany,  Greece,  Italy,  Netherlands,  New Zealand,  Norway,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Reduction in Office Systolic Blood Pressure From Baseline to 6 Months	Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.	Baseline to 6 months
Secondary	Acute Safety: Percentage of Participants With Peri-procedural Events Within 30 Days Post-procedure	The peri-procedural events occurring within 30 days post procedure were summarized as the percentage of the number of participants with peri-procedural events within 30 days post procedure compared to the number of participants at baseline for that population.	30 days post procedure
Secondary	Midterm Safety: Percentage of Participants With New Renal Artery Stenosis and/or Aneurysm at Ablation Site at 6 Months	The new renal artery stenosis (>50%) and/or aneurysm at the site of ablation per Renal Artery Imaging (CT/MR) was summarized at each follow-up visit as the percentage of patients who have stenosis and/or aneurysm. Kaplan-meier analysis was performed on the time to the first new renal artery stenosis and/or aneurysm at the site of ablation, as appropriate.	6 months
Secondary	Midterm Safety: Mean Change in eGFR (mL/Min/1.73m²) From Confirmatory Visit to 6 Months	Renal function change based on eGFR was summarized by computing the change of the eGFR at each follow-up visit compared to baseline for each patient with data available in both time points and calculating the mean and standard deviation of the eGFR change at those intervals.	Confirmatory visit to 6 months
Secondary	Long Term Safety: Percentage of Participants With New Renal Artery Stenosis and/or Aneurysm at Ablation Site at 2 Years	The new renal artery stenosis (>50%) and/or aneurysm at the site of ablation per RenalArtery Imaging (CT/MR) was summarized at each follow-up visit as the percentage of patients who have stenosis and/or aneurysm. Kaplan-meier analysis was performed onthe time to the first new renal artery stenosis and/or aneurysm at the site of ablation, as appropriate.	2 years
Secondary	Long Term Safety: Percentage of Participants With New Renal Artery Stenosis and/or Aneurysm at Ablation Site at 5 Years	The new renal artery stenosis (>50%) and/or aneurysm at the site of ablation per RenalArtery Imaging (CT/MR) was summarized at each follow-up visit as the percentage of patients who have stenosis and/or aneurysm. Kaplan-meier analysis was performed onthe time to the first new renal artery stenosis and/or aneurysm at the site of ablation, as appropriate.	5 years
Secondary	Long Term Safety: Mean Change in eGFR (mL/Min/1.73m²) From Confirmatory Visit to 2 Years	Renal function change based on eGFR was summarized by computing the change of the eGFR at each follow-up visit compared to baseline for each patient with data available in both time points and calculating the mean and standard deviation of the eGFR change at those intervals.	Confirmatory visit to 2 years
Secondary	Long Term Safety: Mean Change in eGFR (mL/Min/1.73m²) From Confirmatory Visit to 5 Years	Renal function change based on eGFR was summarized by computing the change of the eGFR at each follow-up visit compared to baseline for each patient with data available in both time points and calculating the mean and standard deviation of the eGFR change at those intervals.	Confirmatory visit to 5 years
Secondary	Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 6 Months	24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.	Baseline to 6 months
Secondary	Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 6 Months	24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.	Baseline to 6 months
Secondary	Mean Change in Office Diastolic Blood Pressure From Baseline to 6 Months	Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.	Baseline to 6 months
Secondary	Percentage of Participants Achieved Office Systolic Blood Pressure < 140 mmHg at 6 Months	The percentage of participants achieved office systolic blood pressure <140 mmHg at 6 months visit was computed as the percentage of the ratio of number of participants who achievied office systolic blood pressure <140 mmHg at 6 months visit to the number of participants with data available in 6 months visit.	6 months
Secondary	Mean Change in Office Systolic Blood Pressure From Baseline to 1 Year Post Denervation	Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.	Baseline to 1 year
Secondary	Mean Change in Office Systolic Blood Pressure From Baseline to 2 Years Post Denervation	Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.	Baseline to 2 years
Secondary	Mean Change in Office Systolic Blood Pressure From Baseline to 3 Years Post Denervation	Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.	Baseline to 3 years
Secondary	Mean Change in Office Systolic Blood Pressure From Baseline to 4 Years Post Denervation	Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.	Baseline to 4 years
Secondary	Mean Change in Office Systolic Blood Pressure From Baseline to 5 Years Post Denervation	Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.	Baseline to 5 years
Secondary	Mean Change in Office Diastolic Blood Pressure From Baseline to 1 Year Post Denervation	Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.	Baseline to 1 year
Secondary	Mean Change in Office Diastolic Blood Pressure From Baseline to 2 Years Post Denervation	Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.	Baseline to 2 years
Secondary	Mean Change in Office Diastolic Blood Pressure From Baseline to 3 Years Post Denervation	Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.	Baseline to 3 years
Secondary	Mean Change in Office Diastolic Blood Pressure From Baseline to 4 Years Post Denervation	Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.	Baseline to 4 years
Secondary	Mean Change in Office Diastolic Blood Pressure From Baseline to 5 Years Post Denervation	Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.	Baseline to 5 years
Secondary	Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 1 Year Post Denervation	24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.	Baseline to 1 year
Secondary	Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 2 Years Post Denervation	24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.	Baseline to 2 years
Secondary	Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 3 Years Post Denervation	24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.	Baseline to 3 years
Secondary	Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 4 Years Post Denervation	24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.	Baseline to 4 years
Secondary	Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 5 Years Post Denervation	24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.	Baseline to 5 years
Secondary	Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 1 Year Post Denervation	24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.	Baseline to 1 year
Secondary	Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 2 Years Post Denervation	24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.	Baseline to 2 years
Secondary	Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 3 Years Post Denervation	24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.	Baseline to 3 years
Secondary	Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 4 Years Post Denervation	24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.	Baseline to 4 years
Secondary	Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 5 Years Post Denervation	24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.	Baseline to 5 years