Uncontrolled Hypertension
Conditions
Keywords
uncontrolled hypertension, Renal Denervation
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 patients with uncontrolled hypertension in clinical routine practice.
Detailed description
This is a post market, multi-center, open label, observational study. Approximately 500 subjects with uncontrolled hypertension will undergo renal artery ablation at approximately 40 investigational sites located in Germany and will be followed for 1 year post procedure.The expected duration of the investigation will be approximately 4 years.
Interventions
None listed
Sponsors
Abbott Medical Devices
Study design
Observational model
COHORT
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 Systolic Blood Pressure (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), or subject has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE-I/ Angiotensin Receptor Blocker (ARB), Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Reduction in Office Systolic Blood Pressure at 6 Months | 6 months | Positive number indicates a reduction (improvement) in blood pressure |
Other
| Measure | Time frame | Description |
|---|---|---|
| Reduction in Office Systolic Blood Pressure | 12 Months | Positive number indicates a reduction (improvement) in blood pressure |
| Reduction in 24 Hour Ambulatory Systolic Blood Pressure | 12 Months | Positive number indicates a reduction (improvement) in blood pressure |
| Reduction in Office Diastolic Blood Pressure | 6 Months | Positive number indicates a reduction (improvement) in blood pressure |
| Proportion of Subjects Achieving <140mmHg Office Systolic Blood Pressure | 1 Month | Positive number indicates a reduction (improvement) in blood pressure |
| Change in Estimated Glomerular Filtration Rate (eGFR) | 12 Months | Change from baseline in eGFR |
| Reduction in 24 Hour Ambulatory Diastolic Blood Pressure | 12 Months | Positive number indicates a reduction (improvement) in blood pressure |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Full Cohort All subjects - this is a single arm study | 25 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Full Cohort |
|---|---|
| 24Hr Ambulatory Blood Pressure Diastolic | 83.2 mmHg STANDARD_DEVIATION 15.7 |
| 24Hr Ambulatory Blood Pressure Systolic | 157.1 mmHg STANDARD_DEVIATION 18.6 |
| Age, Continuous | 64.3 years STANDARD_DEVIATION 10.5 |
| BMI | 29.9 kilograms/meter2 STANDARD_DEVIATION 5.6 |
| Cerebrovascular Accident | 3 Participants |
| Coronary Artery Bypass Graft | 3 Participants |
| Coronary Artery Disease | 7 Participants |
| Diabetes (Type II) | 13 Participants |
| Estimated Glomerular Filtration Rate | 72.8 mL/min per 1.73m2 STANDARD_DEVIATION 16.1 |
| Heart Rate | 71.2 beats per minute STANDARD_DEVIATION 7.1 |
| Height | 171.2 centimeters STANDARD_DEVIATION 8.4 |
| Myocardial Infarction | 2 Participants |
| Number of Antihypertensive Medications | 4.7 medications STANDARD_DEVIATION 1.1 |
| Obstructive Sleep Apnea | 7 Participants |
| Office Blood Pressure Diastolic | 87.8 mmHg STANDARD_DEVIATION 12.6 |
| Office Blood Pressure Systolic | 164.5 mmHg STANDARD_DEVIATION 20.2 |
| Percutaneous Coronary Intervention | 2 Participants |
| Serum Creatinine | 88.6 micromoles/liter STANDARD_DEVIATION 18.7 |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 14 Participants |
| Smoker | 8 Participants |
| Weight | 88.0 kilograms STANDARD_DEVIATION 18.7 |
| Years since HTN diagnosis | 19.2 years STANDARD_DEVIATION 15.5 |
| Years taking anti-HTN medications | 15.4 years STANDARD_DEVIATION 11.3 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 25 |
| other Total, other adverse events | 4 / 25 |
| serious Total, serious adverse events | 5 / 25 |
Outcome results
Primary
Mean Reduction in Office Systolic Blood Pressure at 6 Months
Positive number indicates a reduction (improvement) in blood pressure
Time frame: 6 months
Population: All subjects with data available at baseline and 6-month follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Full Cohort | Mean Reduction in Office Systolic Blood Pressure at 6 Months | 17.6 mmHg | Standard Deviation 21.5 |
Other Pre-specified
Change in Estimated Glomerular Filtration Rate (eGFR)
Change from baseline in eGFR
Time frame: 12 Months
Population: Subjects with both baseline and follow up data available
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Full Cohort | Change in Estimated Glomerular Filtration Rate (eGFR) | 3.8 mL/min per 1.73m2 | Standard Deviation 10.8 |
Other Pre-specified
Proportion of Subjects Achieving <140mmHg Office Systolic Blood Pressure
Positive number indicates a reduction (improvement) in blood pressure
Time frame: 6 Months
Population: Subjects with baseline and follow up data available
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Full Cohort | Proportion of Subjects Achieving <140mmHg Office Systolic Blood Pressure | 6 Participants |
Other Pre-specified
Proportion of Subjects Achieving <140mmHg Office Systolic Blood Pressure
Positive number indicates a reduction (improvement) in blood pressure
Time frame: 12 Months
Population: Subjects with baseline and follow up data available
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Full Cohort | Proportion of Subjects Achieving <140mmHg Office Systolic Blood Pressure | 3 Participants |
Other Pre-specified
Proportion of Subjects Achieving <140mmHg Office Systolic Blood Pressure
Positive number indicates a reduction (improvement) in blood pressure
Time frame: 1 Month
Population: Subjects with baseline and follow up data available
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Full Cohort | Proportion of Subjects Achieving <140mmHg Office Systolic Blood Pressure | 8 Participants |
Other Pre-specified
Reduction in 24 Hour Ambulatory Diastolic Blood Pressure
Positive number indicates a reduction (improvement) in blood pressure
Time frame: 12 Months
Population: Subjects with baseline and follow up data available
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Full Cohort | Reduction in 24 Hour Ambulatory Diastolic Blood Pressure | 6.7 mmHg | Standard Deviation 10.1 |
Other Pre-specified
Reduction in 24 Hour Ambulatory Systolic Blood Pressure
Positive number indicates a reduction (improvement) in blood pressure
Time frame: 12 Months
Population: Subjects with baseline and follow up data available
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Full Cohort | Reduction in 24 Hour Ambulatory Systolic Blood Pressure | 14.6 mmHg | Standard Deviation 13.7 |
Other Pre-specified
Reduction in Office Diastolic Blood Pressure
Positive number indicates a reduction (improvement) in blood pressure
Time frame: 6 Months
Population: Subjects with baseline and follow up data available
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Full Cohort | Reduction in Office Diastolic Blood Pressure | 9.9 mmHg | Standard Deviation 11.9 |
Other Pre-specified
Reduction in Office Diastolic Blood Pressure
Positive number indicates a reduction (improvement) in blood pressure
Time frame: 12 Months
Population: Subjects with baseline and follow up data available
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Full Cohort | Reduction in Office Diastolic Blood Pressure | 3.6 mmHg | Standard Deviation 17.3 |
Other Pre-specified
Reduction in Office Systolic Blood Pressure
Positive number indicates a reduction (improvement) in blood pressure
Time frame: 12 Months
Population: Subjects with baseline and follow up data available
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Full Cohort | Reduction in Office Systolic Blood Pressure | 7.0 mmHg | Standard Deviation 26 |