Uncontrolled Hypertension
Conditions
Brief summary
The purpose of this observational study is to further evaluate the safety and performance of the EnligHTN™ Renal Denervation System in the treatment of participants with uncontrolled hypertension in clinical routine practice.
Detailed description
The EnligHTN European Observational study is designed to collect more data, critical to the benefit of the therapy, within a clinical routine setting.
Interventions
The EnligHTN™ Renal Denervation System is designed to deliver radiofrequency (RF) energy to the renal nerves to achieve targeted denervation. The system consists of the EnligHTN™ RF Ablation Generator (generator), the EnligHTN™ Renal Artery Ablation Catheter (ablation catheter), and the EnligHTN™ Guiding Catheter (optional).
Sponsors
Abbott Medical Devices
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is planned to undergo a renal denervation procedure for the treatment of hypertension * 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 SBP ≥ 140 mmHg * Subject has established hypertension (diagnosed ≥12 months prior to baseline) and is on a guideline based drug regimen at a stable (≥ 14 days) and a fully tolerated dose consisting of ≥3 anti-hypertensive medications (including 1 diuretic)
Exclusion criteria
* Subject has known 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 a history of hemodynamically significant valvular heart disease * Subject has blood clotting abnormalities * Subject life expectancy is \< 12 months, as determined by the Study Investigator * Subject is participating in another clinical study which has the potential to impact his/her 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 known renal arteries with diameter(s) \< 4 mm * Subject has an estimated GFR \<45 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Change in Office Systolic Blood Pressure at 6 Months | Baseline and 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Achieving Office Systolic Blood Pressure < 140 mmHg at 1 Month | 1 month | — |
| Renal Function Change Based on eGFR (Estimated Glomerular Filtration Rate) at 6 Months | Baseline and 6 months | — |
| Renal Function Change Based on eGFR (Estimated Glomerular Filtration Rate) at 12 Months | Baseline and 12 months | — |
| Assessment of Peri-procedural Adverse Events up Until 30 Days Post Procedure | 30 days | — |
| Mean Change in Office Systolic Blood Pressure at 1 Month | Baseline and 1 month | — |
| Mean Change in Office Diastolic Blood Pressure at 1 Month | Baseline and 1 month | — |
| Mean Change in Ambulatory Systolic Blood Pressure at 1 Month | Baseline and 1 month | — |
| Renovascular Safety at 6 Months (Renal Artery Stenosis) | 6 months | Assessment of renovascular safety as measured by new renal artery stenosis or aneurysm at the site of ablation. |
| Mean Change in Ambulatory Diastolic Blood Pressure at 1 Month | Baseline and 1 month | — |
| Mean Change in Office Diastolic Blood Pressure at 6 Months | Baseline and 6 months | — |
| Mean Change in Office Diastolic Blood Pressure at 12 Months | Baseline and 12 months | — |
| Mean Change in Ambulatory Systolic Blood Pressure at 6 Months | Baseline and 6 months | — |
| Mean Change in Ambulatory Systolic Blood Pressure at 12 Months | Baseline and 12 months | — |
| Mean Change in Ambulatory Diastolic Blood Pressure at 6 Months | Baseline and 6 months | — |
| Mean Change in Ambulatory Diastolic Blood Pressure at 12 Months | Baseline and 12 months | — |
| Percentage of Participants Achieving Office Systolic Blood Pressure < 140 mmHg at 6 Months | 6 months | — |
| Percentage of Participants Achieving Office Systolic Blood Pressure < 140 mmHg at 12 Months | 12 months | — |
| Mean Change in Office Systolic Blood Pressure at 12 Months | Baseline and 12 months | — |
Countries
Belgium, Estonia, Italy, Portugal, Spain, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Uncontrolled Hypertension Participants Renal denervation procedure with the EnligHTN System for the treatment of uncontrolled hypertension | 68 |
| Total | 68 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | Other | 2 |
| Overall Study | Procedurally excluded | 1 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Uncontrolled Hypertension Participants | — |
|---|---|---|
| Additional Medical History Diabetes | 25 Participants | — |
| Additional Medical History Hyperlipidemia | 27 Participants | — |
| Additional Medical History Significant Alcohol intake | 5 Participants | — |
| Additional Medical History Smoker | 21 Participants | — |
| Age, Continuous | 59.1 years STANDARD_DEVIATION 11.8 | — |
| Ambulatory Blood Pressure 24 Hour Diastolic Blood Pressure | 86.6 mmHg STANDARD_DEVIATION 14.7 | — |
| Ambulatory Blood Pressure 24 Hour Systolic Blood Pressure | 155.0 mmHg STANDARD_DEVIATION 16.9 | — |
| Ambulatory Blood Pressure Day time Diastolic Blood Pressure | 89.2 mmHg STANDARD_DEVIATION 14.9 | — |
| Ambulatory Blood Pressure Day time Systolic Blood Pressure | 158.1 mmHg STANDARD_DEVIATION 17.1 | — |
| Ambulatory Blood Pressure Night time Diastolic Blood Pressure | 80.5 mmHg STANDARD_DEVIATION 16.1 | — |
| Ambulatory Blood Pressure Night time Systolic Blood Pressure | 149.6 mmHg STANDARD_DEVIATION 23.6 | — |
| Antiarrhythmic Medication currently being taken ACE/angiotensin 2 receptor/direct renin inhibitors | 48 Participants | — |
| Antiarrhythmic Medication currently being taken Beta blockers | 42 Participants | — |
| Antiarrhythmic Medication currently being taken Calcium Channel Blocker | 48 Participants | — |
| Antiarrhythmic Medication currently being taken Diuretics | 61 Participants | — |
| Antiarrhythmic Medication currently being taken Other hypertensive medication | 40 Participants | — |
| Cardiovascular History Abdominal Aortic Aneurysm | 0 Participants | — |
| Cardiovascular History Arrhythmias | 6 Participants | — |
| Cardiovascular History Cardiomyopathy | 9 Participants | — |
| Cardiovascular History Coronary Artery Bypass Graft | 2 Participants | — |
| Cardiovascular History Coronary Artery Disease | 14 Participants | — |
| Cardiovascular History Myocardial Infarction | 4 Participants | — |
| Cardiovascular History None | 43 Participants | — |
| Cardiovascular History Percutaneous Coronary Intervention | 10 Participants | — |
| Cardiovascular History Valvular Disease | 3 Participants | — |
| Estimated Glomerular Filtration Rate (eGFR) | 79.1 mL/min per 1.73 m^2 STANDARD_DEVIATION 24.5 | — |
| Heart Rate 24-Hour Ambulatory Heart Rate | 67.7 bpm (beats per minute) STANDARD_DEVIATION 12.1 | — |
| Heart Rate Day time Ambulatory Heart Rate | 70.3 bpm (beats per minute) STANDARD_DEVIATION 13.5 | — |
| Heart Rate Night time Ambulatory Heart Rate | 64.2 bpm (beats per minute) STANDARD_DEVIATION 13.6 | — |
| Heart Rate Office Heart Rate | 69.4 bpm (beats per minute) STANDARD_DEVIATION 11.7 | — |
| Hypertension (HTN) Years since HTN diagnosis | 12.8 years STANDARD_DEVIATION 11.5 | — |
| Hypertension (HTN) Years since subject was on anti-HTN meds | 11.1 years STANDARD_DEVIATION 11.8 | — |
| Neurological history Cerebrovascular accident | 2 Participants | — |
| Neurological history None | 60 Participants | — |
| Neurological history Other | 5 Participants | — |
| Number of anti-HTN medications participant currently takes | 4.3 medications STANDARD_DEVIATION 1 | — |
| Office Blood Pressure Diastolic Blood Pressure | 90.3 mmHg STANDARD_DEVIATION 15.2 | — |
| Office Blood Pressure Systolic Blood Pressure | 163.7 mmHg STANDARD_DEVIATION 22.5 | — |
| Other Renal Disease | 11 Participants | — |
| Participants on stable anti-HTN medication prior to enrollment | 67 Participants | — |
| Physical assessment - Body Mass Index (BMI) | 30.5 kg/m^2 STANDARD_DEVIATION 5 | — |
| Physical Assessment - Height | 169.8 cm STANDARD_DEVIATION 10 | — |
| Physical Assessment - Weight | 88.8 kg STANDARD_DEVIATION 19.3 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Belgium | 11 participants | — |
| Region of Enrollment Estonia | 3 participants | — |
| Region of Enrollment Italy | 27 participants | — |
| Region of Enrollment Portugal | 5 participants | — |
| Region of Enrollment Spain | 16 participants | — |
| Region of Enrollment United Kingdom | 6 participants | — |
| Renal artery atherosclerosis | 2 Participants | — |
| Renal artery atherosclerosis percentage Percentage (%) of atherosclerosis on the left | NA percentage (%) | — |
| Renal artery atherosclerosis percentage Percentage (%) of atherosclerosis on the right | 25 percentage (%) STANDARD_DEVIATION 0 | — |
| Renovascular Hypertension | 0 Participants | — |
| Serum creatinine concentration | 86.1 umol/L STANDARD_DEVIATION 27.9 | — |
| Sex: Female, Male Female | 30 Participants | — |
| Sex: Female, Male Male | 37 Participants | — |
| Urine Albumin to Creatinine Ratio | 89.6 mg/g STANDARD_DEVIATION 235 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 68 |
| other Total, other adverse events | 5 / 68 |
| serious Total, serious adverse events | 8 / 68 |
Outcome results
Primary
Mean Change in Office Systolic Blood Pressure at 6 Months
Time frame: Baseline and 6 months
Population: 58 out of 67 participants analyzed for primary outcome measure of office systolic blood pressure at 6 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Uncontrolled Hypertension Participants | Mean Change in Office Systolic Blood Pressure at 6 Months | -13.6 mmHg | Standard Deviation 29.2 |
Secondary
Assessment of Peri-procedural Adverse Events up Until 30 Days Post Procedure
Time frame: 30 days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Uncontrolled Hypertension Participants | Assessment of Peri-procedural Adverse Events up Until 30 Days Post Procedure | Back Pain | 1 Participants |
| Uncontrolled Hypertension Participants | Assessment of Peri-procedural Adverse Events up Until 30 Days Post Procedure | Renal Artery Stenosis | 1 Participants |
| Uncontrolled Hypertension Participants | Assessment of Peri-procedural Adverse Events up Until 30 Days Post Procedure | Urinary Tract Infection | 1 Participants |
| Uncontrolled Hypertension Participants | Assessment of Peri-procedural Adverse Events up Until 30 Days Post Procedure | Viral Syndrome | 1 Participants |
Secondary
Mean Change in Ambulatory Diastolic Blood Pressure at 12 Months
Time frame: Baseline and 12 months
Population: 25 out of 67 participants analyzed for mean change in ambulatory Diastolic Blood Pressure at 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Uncontrolled Hypertension Participants | Mean Change in Ambulatory Diastolic Blood Pressure at 12 Months | -4.2 mmHg | Standard Deviation 10.4 |
Secondary
Mean Change in Ambulatory Diastolic Blood Pressure at 1 Month
Time frame: Baseline and 1 month
Population: 23 out of 67 participants analyzed for mean change in ambulatory Diastolic Blood Pressure at 1 month.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Uncontrolled Hypertension Participants | Mean Change in Ambulatory Diastolic Blood Pressure at 1 Month | -3.6 mmHg | Standard Deviation 9.7 |
Secondary
Mean Change in Ambulatory Diastolic Blood Pressure at 6 Months
Time frame: Baseline and 6 months
Population: 29 out of 67 participants analyzed for mean change in ambulatory Diastolic Blood Pressure at 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Uncontrolled Hypertension Participants | Mean Change in Ambulatory Diastolic Blood Pressure at 6 Months | -5.6 mmHg | Standard Deviation 7.1 |
Secondary
Mean Change in Ambulatory Systolic Blood Pressure at 12 Months
Time frame: Baseline and 12 months
Population: 25 out of 67 participants analyzed for mean change in ambulatory Systolic Blood Pressure at 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Uncontrolled Hypertension Participants | Mean Change in Ambulatory Systolic Blood Pressure at 12 Months | -6.4 mmHg | Standard Deviation 19.5 |
Secondary
Mean Change in Ambulatory Systolic Blood Pressure at 1 Month
Time frame: Baseline and 1 month
Population: 23 out of 67 participants analyzed for mean change in ambulatory Systolic Blood Pressure at 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Uncontrolled Hypertension Participants | Mean Change in Ambulatory Systolic Blood Pressure at 1 Month | -6.8 mmHg | Standard Deviation 18.2 |
Secondary
Mean Change in Ambulatory Systolic Blood Pressure at 6 Months
Time frame: Baseline and 6 months
Population: 29 out of 67 participants analyzed for mean change in ambulatory Systolic Blood Pressure at 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Uncontrolled Hypertension Participants | Mean Change in Ambulatory Systolic Blood Pressure at 6 Months | -10.8 mmHg | Standard Deviation 13.7 |
Secondary
Mean Change in Office Diastolic Blood Pressure at 12 Months
Time frame: Baseline and 12 months
Population: 54 out of 67 participants analyzed for mean change in office Diastolic Blood Pressure at 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Uncontrolled Hypertension Participants | Mean Change in Office Diastolic Blood Pressure at 12 Months | -7.1 mmHg | Standard Deviation 16.1 |
Secondary
Mean Change in Office Diastolic Blood Pressure at 1 Month
Time frame: Baseline and 1 month
Population: 61 out of 67 analyzed for mean change in office Diastolic Blood Pressure at 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Uncontrolled Hypertension Participants | Mean Change in Office Diastolic Blood Pressure at 1 Month | -4.6 mmHg | Standard Deviation 16.7 |
Secondary
Mean Change in Office Diastolic Blood Pressure at 6 Months
Time frame: Baseline and 6 months
Population: 58 out of 67 participants analyzed for mean change in office Diastolic Blood Pressure at 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Uncontrolled Hypertension Participants | Mean Change in Office Diastolic Blood Pressure at 6 Months | -6.7 mmHg | Standard Deviation 17.6 |
Secondary
Mean Change in Office Systolic Blood Pressure at 12 Months
Time frame: Baseline and 12 months
Population: 54 out of 67 participants analyzed for mean change in office Systolic Blood Pressure at 12 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Uncontrolled Hypertension Participants | Mean Change in Office Systolic Blood Pressure at 12 Months | -13.8 mmHg | Standard Deviation 24.7 |
Secondary
Mean Change in Office Systolic Blood Pressure at 1 Month
Time frame: Baseline and 1 month
Population: 61 out of 67 participants were analyzed for mean reduction in office Systolic Blood Pressure at 1 month.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Uncontrolled Hypertension Participants | Mean Change in Office Systolic Blood Pressure at 1 Month | -13.0 mmHg | Standard Deviation 28.2 |
Secondary
Percentage of Participants Achieving Office Systolic Blood Pressure < 140 mmHg at 12 Months
Time frame: 12 months
Population: 55 out of 67 participants were analyzed for percentage of subjects achieving office Systolic Blood Pressure \< 140 mmHg at 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Uncontrolled Hypertension Participants | Percentage of Participants Achieving Office Systolic Blood Pressure < 140 mmHg at 12 Months | 19 Participants |
Secondary
Percentage of Participants Achieving Office Systolic Blood Pressure < 140 mmHg at 6 Months
Time frame: 6 months
Population: 59 out of 67 participants were analyzed for percentage of subjects achieving office Systolic Blood Pressure \< 140 mmHg at 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Uncontrolled Hypertension Participants | Percentage of Participants Achieving Office Systolic Blood Pressure < 140 mmHg at 6 Months | 21 Participants |
Secondary
Percentage of Subjects Achieving Office Systolic Blood Pressure < 140 mmHg at 1 Month
Time frame: 1 month
Population: 62 out of 67 participants analyzed for percentage of subjects achieving office Systolic Blood Pressure \< 140 mmHg at 1 month.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Uncontrolled Hypertension Participants | Percentage of Subjects Achieving Office Systolic Blood Pressure < 140 mmHg at 1 Month | 24 Participants |
Secondary
Renal Function Change Based on eGFR (Estimated Glomerular Filtration Rate) at 12 Months
Time frame: Baseline and 12 months
Population: 38 out of 67 analyzed for renal function change based on eGFR at 12 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Uncontrolled Hypertension Participants | 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
Renal Function Change Based on eGFR (Estimated Glomerular Filtration Rate) at 6 Months
Time frame: Baseline and 6 months
Population: 48 out of 67 analyzed for renal function change based on eGFR at 6 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Uncontrolled Hypertension Participants | 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
Renovascular Safety at 6 Months (Renal Artery Stenosis)
Assessment of renovascular safety as measured by new renal artery stenosis or aneurysm at the site of ablation.
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Uncontrolled Hypertension Participants | Renovascular Safety at 6 Months (Renal Artery Stenosis) | 1 Participants |
Post Hoc
Number of Anti-hypertensive Medications Participant Currently Takes at 12 Months
Time frame: 12 months
Population: 55 out of 67 participants were analyzed for number of anti-hypertensive medications taken at 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Uncontrolled Hypertension Participants | Number of Anti-hypertensive Medications Participant Currently Takes at 12 Months | 3.7 number of medications | Standard Deviation 1.5 |
Post Hoc
Serum Creatinine Concentration at 12 Months
Time frame: 12 months
Population: 46 out of 67 analyzed for serum creatinine concentration at 6 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Uncontrolled Hypertension Participants | Serum Creatinine Concentration at 12 Months | 90.2 umol | Standard Deviation 29.5 |
Post Hoc
Serum Creatinine Concentration at 6 Months
Time frame: 6 months
Population: 55 out of 67 analyzed for serum creatinine concentration at 6 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Uncontrolled Hypertension Participants | Serum Creatinine Concentration at 6 Months | 227.9 umol | Standard Deviation 1013.1 |
Post Hoc
Urine Albumin to Creatinine Ratio at 12 Months
Time frame: 12 months
Population: 14 out of 67 analyzed for serum creatinine concentration at 6 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Uncontrolled Hypertension Participants | Urine Albumin to Creatinine Ratio at 12 Months | 179.0 mg/g | Standard Deviation 373.1 |
Post Hoc
Urine Albumin to Creatinine Ratio at 6 Months
Time frame: 6 months
Population: 17 out of 67 analyzed for serum creatinine concentration at 6 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Uncontrolled Hypertension Participants | Urine Albumin to Creatinine Ratio at 6 Months | 212.8 mg/g | Standard Deviation 635.1 |