Trial Outcomes & Findings for Observational Study of the EnligHTN Renal Denervation System in Europe (NCT NCT02006758)

NCT ID: NCT02006758

Last Updated: 2019-10-16

Results Overview

• Recruitment status: COMPLETED
• Target enrollment: 68 participants
• Primary outcome timeframe: Baseline and 6 months
• Results posted on: 2019-10-16

Participant Flow

Participant milestones

Measure	Uncontrolled Hypertension Participants Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension
Overall Study STARTED	68
Overall Study Underwent Renal Denervation	67
Overall Study 1-month Follow up	66
Overall Study 6-month Follow up	60
Overall Study 12-month Follow up	55
Overall Study COMPLETED	55
Overall Study NOT COMPLETED	13

Reasons for withdrawal

Measure	Uncontrolled Hypertension Participants Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension
Overall Study Protocol Violation	1
Overall Study Death	1
Overall Study Lost to Follow-up	4
Overall Study Withdrawal by Subject	4
Overall Study Procedurally excluded	1
Overall Study Other	2

Baseline Characteristics

1 participant was excluded due to inclusion criteria violation

Baseline characteristics by cohort

Measure	Uncontrolled Hypertension Participants n=68 Participants Renal denervation procedure with the EnligHTN System for the treatment of uncontrolled hypertension
Age, Continuous	59.1 years STANDARD_DEVIATION 11.8 • n=67 Participants • 1 participant was excluded due to inclusion criteria violation
Sex: Female, Male Female	30 Participants n=67 Participants • 1 participant was excluded due to inclusion criteria violation
Sex: Female, Male Male	37 Participants n=67 Participants • 1 participant was excluded due to inclusion criteria violation
Region of Enrollment Belgium	11 participants n=68 Participants
Region of Enrollment Estonia	3 participants n=68 Participants
Region of Enrollment Italy	27 participants n=68 Participants
Region of Enrollment Portugal	5 participants n=68 Participants
Region of Enrollment Spain	16 participants n=68 Participants
Region of Enrollment United Kingdom	6 participants n=68 Participants
Physical Assessment - Weight	88.8 kg STANDARD_DEVIATION 19.3 • n=67 Participants • 1 participant was excluded due to inclusion criteria violation
Physical Assessment - Height	169.8 cm STANDARD_DEVIATION 10.0 • n=67 Participants • 1 subject was excluded due to inclusion criteria violation
Physical assessment - Body Mass Index (BMI)	30.5 kg/m^2 STANDARD_DEVIATION 5.0 • n=67 Participants • 1 participant was excluded due to inclusion criteria violation
Hypertension (HTN) Years since HTN diagnosis	12.8 years STANDARD_DEVIATION 11.5 • n=49 Participants • Data were not collected for all participants.
Hypertension (HTN) Years since subject was on anti-HTN meds	11.1 years STANDARD_DEVIATION 11.8 • n=35 Participants • Data were not collected for all participants.
Renal artery atherosclerosis	2 Participants n=67 Participants • 1 participant was excluded due to inclusion criteria violation
Renal artery atherosclerosis percentage Percentage (%) of atherosclerosis on the right	25 percentage (%) STANDARD_DEVIATION 0.0 • n=2 Participants • 2 participants had renal artery atherosclerosis, of which both were located on the right side.
Renal artery atherosclerosis percentage Percentage (%) of atherosclerosis on the left	NA percentage (%) STANDARD_DEVIATION NA • n=2 Participants • 2 participants had renal artery atherosclerosis, of which both were located on the right side.
Renovascular Hypertension	0 Participants n=67 Participants • 1 participant was excluded due to inclusion criteria violation
Other Renal Disease	11 Participants n=67 Participants • 1 participant was excluded due to inclusion criteria violation
Cardiovascular History None	43 Participants n=67 Participants • 1 participant was excluded because of inclusion criteria violation.
Cardiovascular History Myocardial Infarction	4 Participants n=67 Participants • 1 participant was excluded because of inclusion criteria violation.
Cardiovascular History Coronary Artery Disease	14 Participants n=67 Participants • 1 participant was excluded because of inclusion criteria violation.
Cardiovascular History Coronary Artery Bypass Graft	2 Participants n=67 Participants • 1 participant was excluded because of inclusion criteria violation.
Cardiovascular History Percutaneous Coronary Intervention	10 Participants n=67 Participants • 1 participant was excluded because of inclusion criteria violation.
Cardiovascular History Abdominal Aortic Aneurysm	0 Participants n=67 Participants • 1 participant was excluded because of inclusion criteria violation.
Cardiovascular History Valvular Disease	3 Participants n=67 Participants • 1 participant was excluded because of inclusion criteria violation.
Cardiovascular History Arrhythmias	6 Participants n=67 Participants • 1 participant was excluded because of inclusion criteria violation.
Cardiovascular History Cardiomyopathy	9 Participants n=67 Participants • 1 participant was excluded because of inclusion criteria violation.
Neurological history None	60 Participants n=67 Participants • 1 participant was excluded due to inclusion criteria violation
Neurological history Cerebrovascular accident	2 Participants n=67 Participants • 1 participant was excluded due to inclusion criteria violation
Neurological history Other	5 Participants n=67 Participants • 1 participant was excluded due to inclusion criteria violation
Additional Medical History Hyperlipidemia	27 Participants n=67 Participants • 1 participant was excluded due to inclusion criteria violation
Additional Medical History Diabetes	25 Participants n=67 Participants • 1 participant was excluded due to inclusion criteria violation
Additional Medical History Smoker	21 Participants n=67 Participants • 1 participant was excluded due to inclusion criteria violation
Additional Medical History Significant Alcohol intake	5 Participants n=67 Participants • 1 participant was excluded due to inclusion criteria violation
Office Blood Pressure Systolic Blood Pressure	163.7 mmHg STANDARD_DEVIATION 22.5 • n=66 Participants • Data were not collected for all participants.
Office Blood Pressure Diastolic Blood Pressure	90.3 mmHg STANDARD_DEVIATION 15.2 • n=66 Participants • Data were not collected for all participants.
Ambulatory Blood Pressure 24 Hour Systolic Blood Pressure	155.0 mmHg STANDARD_DEVIATION 16.9 • n=35 Participants • Data were not collected for all participants
Ambulatory Blood Pressure 24 Hour Diastolic Blood Pressure	86.6 mmHg STANDARD_DEVIATION 14.7 • n=35 Participants • Data were not collected for all participants
Ambulatory Blood Pressure Day time Systolic Blood Pressure	158.1 mmHg STANDARD_DEVIATION 17.1 • n=35 Participants • Data were not collected for all participants
Ambulatory Blood Pressure Day time Diastolic Blood Pressure	89.2 mmHg STANDARD_DEVIATION 14.9 • n=35 Participants • Data were not collected for all participants
Ambulatory Blood Pressure Night time Systolic Blood Pressure	149.6 mmHg STANDARD_DEVIATION 23.6 • n=35 Participants • Data were not collected for all participants
Ambulatory Blood Pressure Night time Diastolic Blood Pressure	80.5 mmHg STANDARD_DEVIATION 16.1 • n=35 Participants • Data were not collected for all participants
Heart Rate Office Heart Rate	69.4 bpm (beats per minute) STANDARD_DEVIATION 11.7 • n=65 Participants • Data were not collected for all participants
Heart Rate 24-Hour Ambulatory Heart Rate	67.7 bpm (beats per minute) STANDARD_DEVIATION 12.1 • n=31 Participants • Data were not collected for all participants
Heart Rate Day time Ambulatory Heart Rate	70.3 bpm (beats per minute) STANDARD_DEVIATION 13.5 • n=30 Participants • Data were not collected for all participants
Heart Rate Night time Ambulatory Heart Rate	64.2 bpm (beats per minute) STANDARD_DEVIATION 13.6 • n=30 Participants • Data were not collected for all participants
Participants on stable anti-HTN medication prior to enrollment	67 Participants n=67 Participants • 1 participant was excluded due to inclusion criteria violation
Number of anti-HTN medications participant currently takes	4.3 medications STANDARD_DEVIATION 1.0 • n=67 Participants • 1 participant was excluded due to inclusion criteria violation
Antiarrhythmic Medication currently being taken ACE/angiotensin 2 receptor/direct renin inhibitors	48 Participants n=68 Participants • Antihypertensive medication usage information was available for all enrolled participants
Antiarrhythmic Medication currently being taken Beta blockers	42 Participants n=68 Participants • Antihypertensive medication usage information was available for all enrolled participants
Antiarrhythmic Medication currently being taken Calcium Channel Blocker	48 Participants n=68 Participants • Antihypertensive medication usage information was available for all enrolled participants
Antiarrhythmic Medication currently being taken Diuretics	61 Participants n=68 Participants • Antihypertensive medication usage information was available for all enrolled participants
Antiarrhythmic Medication currently being taken Other hypertensive medication	40 Participants n=68 Participants • Antihypertensive medication usage information was available for all enrolled participants
Serum creatinine concentration	86.1 umol/L STANDARD_DEVIATION 27.9 • n=63 Participants • Data were not collected for all participants
Estimated Glomerular Filtration Rate (eGFR)	79.1 mL/min per 1.73 m^2 STANDARD_DEVIATION 24.5 • n=53 Participants • Data were not collected for all participants
Urine Albumin to Creatinine Ratio	89.6 mg/g STANDARD_DEVIATION 235 • n=12 Participants • Data were not collected for all participants

PRIMARY outcome

Timeframe: Baseline and 6 months

Population: 58 out of 67 participants analyzed for primary outcome measure of office systolic blood pressure at 6 months.

Outcome measures

Measure	Uncontrolled Hypertension Participants n=58 Participants Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension
Mean Change in Office Systolic Blood Pressure at 6 Months	-13.6 mmHg Standard Deviation 29.2

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Measure	Uncontrolled Hypertension Participants n=67 Participants Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension
Assessment of Peri-procedural Adverse Events up Until 30 Days Post Procedure Back Pain	1 Participants
Assessment of Peri-procedural Adverse Events up Until 30 Days Post Procedure Renal Artery Stenosis	1 Participants
Assessment of Peri-procedural Adverse Events up Until 30 Days Post Procedure Urinary Tract Infection	1 Participants
Assessment of Peri-procedural Adverse Events up Until 30 Days Post Procedure Viral Syndrome	1 Participants

SECONDARY outcome

Timeframe: Baseline and 1 month

Population: 61 out of 67 participants were analyzed for mean reduction in office Systolic Blood Pressure at 1 month.

Outcome measures

Measure	Uncontrolled Hypertension Participants n=61 Participants Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension
Mean Change in Office Systolic Blood Pressure at 1 Month	-13.0 mmHg Standard Deviation 28.2

SECONDARY outcome

Timeframe: Baseline and 1 month

Population: 61 out of 67 analyzed for mean change in office Diastolic Blood Pressure at 1 month

Outcome measures

Measure	Uncontrolled Hypertension Participants n=61 Participants Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension
Mean Change in Office Diastolic Blood Pressure at 1 Month	-4.6 mmHg Standard Deviation 16.7

SECONDARY outcome

Timeframe: Baseline and 1 month

Population: 23 out of 67 participants analyzed for mean change in ambulatory Systolic Blood Pressure at 1 month

Outcome measures

Measure	Uncontrolled Hypertension Participants n=23 Participants Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension
Mean Change in Ambulatory Systolic Blood Pressure at 1 Month	-6.8 mmHg Standard Deviation 18.2

SECONDARY outcome

Timeframe: Baseline and 1 month

Population: 23 out of 67 participants analyzed for mean change in ambulatory Diastolic Blood Pressure at 1 month.

Outcome measures

Measure	Uncontrolled Hypertension Participants n=23 Participants Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension
Mean Change in Ambulatory Diastolic Blood Pressure at 1 Month	-3.6 mmHg Standard Deviation 9.7

SECONDARY outcome

Timeframe: 1 month

Population: 62 out of 67 participants analyzed for percentage of subjects achieving office Systolic Blood Pressure \< 140 mmHg at 1 month.

Outcome measures

Measure	Uncontrolled Hypertension Participants n=62 Participants Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension
Percentage of Subjects Achieving Office Systolic Blood Pressure < 140 mmHg at 1 Month	24 Participants

SECONDARY outcome

Timeframe: Baseline and 6 months

Population: 48 out of 67 analyzed for renal function change based on eGFR at 6 months.

Outcome measures

Measure	Uncontrolled Hypertension Participants n=48 Participants Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension
Renal Function Change Based on eGFR (Estimated Glomerular Filtration Rate) at 6 Months	-1.0 mL/min per 1.73 m^2 Standard Deviation 21.3

SECONDARY outcome

Timeframe: Baseline and 12 months

Population: 38 out of 67 analyzed for renal function change based on eGFR at 12 months.

Outcome measures

Measure	Uncontrolled Hypertension Participants n=38 Participants Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension
Renal Function Change Based on eGFR (Estimated Glomerular Filtration Rate) at 12 Months	-2.2 mL/min per 1.73 m^2 Standard Deviation 21.1

SECONDARY outcome

Timeframe: 6 months

Assessment of renovascular safety as measured by new renal artery stenosis or aneurysm at the site of ablation.

Outcome measures

Measure	Uncontrolled Hypertension Participants n=67 Participants Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension
Renovascular Safety at 6 Months (Renal Artery Stenosis)	1 Participants

SECONDARY outcome

Timeframe: Baseline and 12 months

Population: 54 out of 67 participants analyzed for mean change in office Systolic Blood Pressure at 12 months.

Outcome measures

Measure	Uncontrolled Hypertension Participants n=54 Participants Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension
Mean Change in Office Systolic Blood Pressure at 12 Months	-13.8 mmHg Standard Deviation 24.7

SECONDARY outcome

Timeframe: Baseline and 6 months

Population: 58 out of 67 participants analyzed for mean change in office Diastolic Blood Pressure at 6 months

Outcome measures

Measure	Uncontrolled Hypertension Participants n=58 Participants Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension
Mean Change in Office Diastolic Blood Pressure at 6 Months	-6.7 mmHg Standard Deviation 17.6

SECONDARY outcome

Timeframe: Baseline and 12 months

Population: 54 out of 67 participants analyzed for mean change in office Diastolic Blood Pressure at 12 months

Outcome measures

Measure	Uncontrolled Hypertension Participants n=54 Participants Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension
Mean Change in Office Diastolic Blood Pressure at 12 Months	-7.1 mmHg Standard Deviation 16.1

SECONDARY outcome

Timeframe: Baseline and 6 months

Population: 29 out of 67 participants analyzed for mean change in ambulatory Systolic Blood Pressure at 6 months

Outcome measures

Measure	Uncontrolled Hypertension Participants n=29 Participants Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension
Mean Change in Ambulatory Systolic Blood Pressure at 6 Months	-10.8 mmHg Standard Deviation 13.7

SECONDARY outcome

Timeframe: Baseline and 12 months

Population: 25 out of 67 participants analyzed for mean change in ambulatory Systolic Blood Pressure at 12 months

Outcome measures

Measure	Uncontrolled Hypertension Participants n=25 Participants Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension
Mean Change in Ambulatory Systolic Blood Pressure at 12 Months	-6.4 mmHg Standard Deviation 19.5

SECONDARY outcome

Timeframe: Baseline and 6 months

Population: 29 out of 67 participants analyzed for mean change in ambulatory Diastolic Blood Pressure at 6 months

Outcome measures

Measure	Uncontrolled Hypertension Participants n=29 Participants Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension
Mean Change in Ambulatory Diastolic Blood Pressure at 6 Months	-5.6 mmHg Standard Deviation 7.1

SECONDARY outcome

Timeframe: Baseline and 12 months

Population: 25 out of 67 participants analyzed for mean change in ambulatory Diastolic Blood Pressure at 12 months

Outcome measures

Measure	Uncontrolled Hypertension Participants n=25 Participants Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension
Mean Change in Ambulatory Diastolic Blood Pressure at 12 Months	-4.2 mmHg Standard Deviation 10.4

SECONDARY outcome

Timeframe: 6 months

Population: 59 out of 67 participants were analyzed for percentage of subjects achieving office Systolic Blood Pressure \< 140 mmHg at 6 months

Outcome measures

Measure	Uncontrolled Hypertension Participants n=59 Participants Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension
Percentage of Participants Achieving Office Systolic Blood Pressure < 140 mmHg at 6 Months	21 Participants

SECONDARY outcome

Timeframe: 12 months

Population: 55 out of 67 participants were analyzed for percentage of subjects achieving office Systolic Blood Pressure \< 140 mmHg at 12 months

Outcome measures

Measure	Uncontrolled Hypertension Participants n=55 Participants Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension
Percentage of Participants Achieving Office Systolic Blood Pressure < 140 mmHg at 12 Months	19 Participants

POST_HOC outcome

Timeframe: 6 months

Population: 55 out of 67 analyzed for serum creatinine concentration at 6 months.

Outcome measures

Measure	Uncontrolled Hypertension Participants n=55 Participants Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension
Serum Creatinine Concentration at 6 Months	227.9 umol Standard Deviation 1013.1

POST_HOC outcome

Timeframe: 12 months

Population: 46 out of 67 analyzed for serum creatinine concentration at 6 months.

Outcome measures

Measure	Uncontrolled Hypertension Participants n=46 Participants Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension
Serum Creatinine Concentration at 12 Months	90.2 umol Standard Deviation 29.5

POST_HOC outcome

Timeframe: 6 months

Population: 17 out of 67 analyzed for serum creatinine concentration at 6 months.

Outcome measures

Measure	Uncontrolled Hypertension Participants n=17 Participants Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension
Urine Albumin to Creatinine Ratio at 6 Months	212.8 mg/g Standard Deviation 635.1

POST_HOC outcome

Timeframe: 12 months

Population: 14 out of 67 analyzed for serum creatinine concentration at 6 months.

Outcome measures

Measure	Uncontrolled Hypertension Participants n=14 Participants Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension
Urine Albumin to Creatinine Ratio at 12 Months	179.0 mg/g Standard Deviation 373.1

POST_HOC outcome

Timeframe: 12 months

Population: 55 out of 67 participants were analyzed for number of anti-hypertensive medications taken at 12 months

Outcome measures

Measure	Uncontrolled Hypertension Participants n=55 Participants Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension
Number of Anti-hypertensive Medications Participant Currently Takes at 12 Months	3.7 number of medications Standard Deviation 1.5

Adverse Events

Uncontrolled Hypertension Participants

Serious events: 8 serious events

Other events: 5 other events

Deaths: 1 deaths

Serious adverse events

Measure	Uncontrolled Hypertension Participants n=68 participants at risk Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension
Gastrointestinal disorders Inguinal hernia	1.5% 1/68 • Number of events 1 • Adverse event data were collected over 12 months.
Cardiac disorders Myocardial Infarction	1.5% 1/68 • Number of events 1 • Adverse event data were collected over 12 months.
Cardiac disorders Myocardial Ischemia	1.5% 1/68 • Number of events 1 • Adverse event data were collected over 12 months.
Vascular disorders Renal Artery Stenosis	1.5% 1/68 • Number of events 1 • Adverse event data were collected over 12 months.
Infections and infestations Sepsis	1.5% 1/68 • Number of events 1 • Adverse event data were collected over 12 months.
Cardiac disorders Sustained Atrial Fibrillation	1.5% 1/68 • Number of events 1 • Adverse event data were collected over 12 months.
Infections and infestations Viral Syndrome	1.5% 1/68 • Number of events 1 • Adverse event data were collected over 12 months.
Vascular disorders VASC Vessel Stenosis	1.5% 1/68 • Number of events 1 • Adverse event data were collected over 12 months.

Other adverse events

Measure	Uncontrolled Hypertension Participants n=68 participants at risk Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension
Musculoskeletal and connective tissue disorders Back Pain	1.5% 1/68 • Number of events 1 • Adverse event data were collected over 12 months.
Cardiac disorders Arterial Hypertension/Hypertension	1.5% 1/68 • Number of events 1 • Adverse event data were collected over 12 months.
Infections and infestations Bacterial Infections of the Skin	1.5% 1/68 • Number of events 1 • Adverse event data were collected over 12 months.
General disorders Drug Side Effect	1.5% 1/68 • Number of events 1 • Adverse event data were collected over 12 months.
Infections and infestations Urinary Tract Infections	1.5% 1/68 • Number of events 1 • Adverse event data were collected over 12 months.

Additional Information

Rebecca Maslow, MA, Clinical Project Manager

Abbott

Phone: +1 651-756-5564

Email: rebecca.maslow@abbott.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place