Hypertension
Conditions
Keywords
Catheter-based renal artery ablation, Hypertension, Resistant to Conventional Therapy
Brief summary
This is a prospective, multicenter, feasibility study on the safety and efficacy of renal denervation in patients with resistant hypertension.
Detailed description
Demonstrate the safety and efficacy of the St. Jude Medical Radiofrequency (RF) Renal Denervation System in the treatment of patients with resistant hypertension. Safety Marker * All adverse events Efficacy Marker * Office blood pressure
Interventions
DEVICESt. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002)
Catheter-based RF ablation in renal artery
Sponsors
Abbott Medical Devices
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Office systolic blood pressure that remains ≥160 mmHg (≥150 mmHg for patient with type 2 diabetes) despite the stable use of ≥3 antihypertensive medications concurrently at maximally tolerated doses, of which one is a diuretic, for a minimum of 14 days prior to enrollment * Age ≥18 and ≤80 years old * Able and willing to provide written informed consent to participate in the study * Able and willing to comply with the required follow-up schedule
Exclusion criteria
* Prior renal artery intervention (balloon angioplasty or stenting) * Evidence of renal artery atherosclerosis (defined as a stenotic severity of \>30%) in either renal artery * Multiple main renal arteries in either kidney * Main renal arteries \<4 mm in diameter or \<20 mm in length * eGFR of \<45 mL/min per 1.73 m2 using the MDRD formula * Type 1 diabetes * Renovascular hypertension or hypertension secondary to other renal disorders (glomerulonephritis, polycystic kidney disease, end-stage renal failure) * Others
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 24 months | All device or procedure related adverse events |
| Office Systolic Blood Pressure Change | Baseline to 6 months | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| 24hr Ambulatory Systolic BP Change | Baseline to 6 months | Average of readings taken every half hour during the course of a 24hr period wearing the ambulatory blood pressure monitor. Includes only subjects who completed the test at both baseline and follow up. If a subject refused to wear the monitor they were excluded. |
| 24hr Ambulatory Diastolic BP Change | Baseline to 6 months | Average of readings taken every half hour during the course of a 24hr period wearing the ambulatory blood pressure monitor. Includes only subjects who completed the test at both baseline and follow up. If a subject refused to wear the monitor they were excluded. |
| Office Diastolic BP Change | Baseline to 6M | — |
| Estimated Glomular Filtration Rate | Baseline | Calculated using Modifide Diet in Renal Disease formula. estimated GFR = 186 x SerumCr-1.154 \* age-0.203 \* 1.212 (if patient is black) \* 0.742 (if female) |
| Cystatin C | Baseline | — |
| Urine Albumin to Creatinine Ratio | Baseline | — |
| Office Systolic BP Change | Baseline to 12M | — |
Countries
Australia, Greece
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Renal Artery Ablation Catheter-based RF ablation in renal artery
St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery | 46 |
| Total | 46 |
Baseline characteristics
| Characteristic | Renal Artery Ablation |
|---|---|
| Age, Continuous | 60 years STANDARD_DEVIATION 10 |
| Body Mass Index | 32 kg/m^2 STANDARD_DEVIATION 5 |
| Coronary Artery Disease No | 37 participants |
| Coronary Artery Disease Yes | 9 participants |
| Cystatin C | 1.1 mg/L STANDARD_DEVIATION 0.3 |
| eGFR | 87 mL/min/1.73m^2 STANDARD_DEVIATION 19 |
| Heart Rate | 71 beats per minute STANDARD_DEVIATION 12 |
| Hyperlipidemia No | 19 participants |
| Hyperlipidemia Yes | 27 participants |
| Number of Anti-Hypertensive Medications | 4.7 medications STANDARD_DEVIATION 1 |
| Office Diastolic Blood Pressure | 96 mmHg STANDARD_DEVIATION 14 |
| Office Systolic Blood Pressure | 176 mmHg STANDARD_DEVIATION 16 |
| Race/Ethnicity, Customized Other | 1 participants |
| Race/Ethnicity, Customized White | 45 participants |
| Region of Enrollment Australia | 26 participants |
| Region of Enrollment Greece | 20 participants |
| Serum Creatinine | 78 mmol/L STANDARD_DEVIATION 17 |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 31 Participants |
| Sleep Apnea No | 32 participants |
| Sleep Apnea Yes | 14 participants |
| Type II Diabetes Mellitus No | 31 participants |
| Type II Diabetes Mellitus Yes | 15 participants |
| Urine Albumin-to-Creatinine Ration | 167.6 mg/g STANDARD_DEVIATION 493 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 32 / 46 |
| serious Total, serious adverse events | 14 / 46 |
Outcome results
Primary
Adverse Events
All device or procedure related adverse events
Time frame: 24 months
Population: All subjects receiving renal artery ablation procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Renal Artery Ablation | Adverse Events | 47.8 percentage of participants |
Primary
Office Systolic Blood Pressure Change
Time frame: Baseline to 6 months
Population: Subjects with both baseline and 6M follow up office blood pressure measurements
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Artery Ablation | Office Systolic Blood Pressure Change | -26 mmHg | Standard Deviation 25 |
p-value: <0.0001t-test, 2 sided
Other Pre-specified
24hr Ambulatory Diastolic BP Change
Average of readings taken every half hour during the course of a 24hr period wearing the ambulatory blood pressure monitor. Includes only subjects who completed the test at both baseline and follow up. If a subject refused to wear the monitor they were excluded.
Time frame: Baseline to 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Artery Ablation | 24hr Ambulatory Diastolic BP Change | -4.3 mmHg | Standard Deviation 8.2 |
Other Pre-specified
24hr Ambulatory Diastolic BP Change
Average of readings taken every half hour during the course of a 24hr period wearing the ambulatory blood pressure monitor. Includes only subjects who completed the test at both baseline and follow up. If a subject refused to wear the monitor they were excluded.
Time frame: Baseline to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Artery Ablation | 24hr Ambulatory Diastolic BP Change | -5.7 mmHg | Standard Deviation 7.9 |
Other Pre-specified
24hr Ambulatory Diastolic BP Change
Average of readings taken every half hour during the course of a 24hr period wearing the ambulatory blood pressure monitor. Includes only subjects who completed the test at both baseline and follow up. If a subject refused to wear the monitor they were excluded.
Time frame: Baseline to 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Artery Ablation | 24hr Ambulatory Diastolic BP Change | -7.5 mmHg | Standard Deviation 8.8 |
Other Pre-specified
24hr Ambulatory Systolic BP Change
Average of readings taken every half hour during the course of a 24hr period wearing the ambulatory blood pressure monitor. Includes only subjects who completed the test at both baseline and follow up. If a subject refused to wear the monitor they were excluded.
Time frame: Baseline to 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Artery Ablation | 24hr Ambulatory Systolic BP Change | -13.2 mmHg | Standard Deviation 15.5 |
Other Pre-specified
24hr Ambulatory Systolic BP Change
Average of readings taken every half hour during the course of a 24hr period wearing the ambulatory blood pressure monitor. Includes only subjects who completed the test at both baseline and follow up. If a subject refused to wear the monitor they were excluded.
Time frame: Baseline to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Artery Ablation | 24hr Ambulatory Systolic BP Change | -10.3 mmHg | Standard Deviation 13.9 |
Other Pre-specified
24hr Ambulatory Systolic BP Change
Average of readings taken every half hour during the course of a 24hr period wearing the ambulatory blood pressure monitor. Includes only subjects who completed the test at both baseline and follow up. If a subject refused to wear the monitor they were excluded.
Time frame: Baseline to 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Artery Ablation | 24hr Ambulatory Systolic BP Change | -6.7 mmHg | Standard Deviation 14.4 |
Other Pre-specified
Cystatin C
Time frame: 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Artery Ablation | Cystatin C | 1.3 mg/L | Standard Deviation 0.4 |
Other Pre-specified
Cystatin C
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Artery Ablation | Cystatin C | 1.1 mg/L | Standard Deviation 0.3 |
Other Pre-specified
Cystatin C
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Artery Ablation | Cystatin C | 1.0 mg/L | Standard Deviation 0.2 |
Other Pre-specified
Cystatin C
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Artery Ablation | Cystatin C | 0.9 mg/L | Standard Deviation 0.2 |
Other Pre-specified
Cystatin C
Time frame: 18 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Artery Ablation | Cystatin C | 1.1 mg/L | Standard Deviation 0.3 |
Other Pre-specified
Estimated Glomular Filtration Rate
Calculated using Modifide Diet in Renal Disease formula. estimated GFR = 186 x SerumCr-1.154 \* age-0.203 \* 1.212 (if patient is black) \* 0.742 (if female)
Time frame: 18 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Artery Ablation | Estimated Glomular Filtration Rate | 75.5 mL/min per 1.73m^2 | Standard Deviation 18.6 |
Other Pre-specified
Estimated Glomular Filtration Rate
Calculated using Modifide Diet in Renal Disease formula. estimated GFR = 186 x SerumCr-1.154 \* age-0.203 \* 1.212 (if patient is black) \* 0.742 (if female)
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Artery Ablation | Estimated Glomular Filtration Rate | 79.8 mL/min per 1.73m^2 | Standard Deviation 19.5 |
Other Pre-specified
Estimated Glomular Filtration Rate
Calculated using Modifide Diet in Renal Disease formula. estimated GFR = 186 x SerumCr-1.154 \* age-0.203 \* 1.212 (if patient is black) \* 0.742 (if female)
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Artery Ablation | Estimated Glomular Filtration Rate | 84.7 mL/min per 1.73m^2 | Standard Deviation 18 |
Other Pre-specified
Estimated Glomular Filtration Rate
Calculated using Modifide Diet in Renal Disease formula. estimated GFR = 186 x SerumCr-1.154 \* age-0.203 \* 1.212 (if patient is black) \* 0.742 (if female)
Time frame: 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Artery Ablation | Estimated Glomular Filtration Rate | 76.4 mL/min per 1.73m^2 | Standard Deviation 25.3 |
Other Pre-specified
Estimated Glomular Filtration Rate
Calculated using Modifide Diet in Renal Disease formula. estimated GFR = 186 x SerumCr-1.154 \* age-0.203 \* 1.212 (if patient is black) \* 0.742 (if female)
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Artery Ablation | Estimated Glomular Filtration Rate | 84.2 mL/min per 1.73m^2 | Standard Deviation 20.3 |
Other Pre-specified
Office Diastolic BP Change
Time frame: Baseline to 18 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Artery Ablation | Office Diastolic BP Change | -10.1 mmHg | Standard Deviation 11.9 |
Other Pre-specified
Office Diastolic BP Change
Time frame: Baseline to 6M
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Artery Ablation | Office Diastolic BP Change | -10.5 mmHg | Standard Deviation 12.2 |
Other Pre-specified
Office Diastolic BP Change
Time frame: Baseline to 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Artery Ablation | Office Diastolic BP Change | -10.7 mmHg | Standard Deviation 12.6 |
Other Pre-specified
Office Diastolic BP Change
Time frame: Baseline to 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Artery Ablation | Office Diastolic BP Change | -13.3 mmHg | Standard Deviation 14.8 |
Other Pre-specified
Office Systolic BP Change
Time frame: Baseline to 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Artery Ablation | Office Systolic BP Change | -29.1 mmHg | Standard Deviation 26.1 |
Other Pre-specified
Office Systolic BP Change
Time frame: Baseline to 18 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Artery Ablation | Office Systolic BP Change | -24.1 mmHg | Standard Deviation 20.4 |
Other Pre-specified
Office Systolic BP Change
Time frame: Baseline to 12M
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Artery Ablation | Office Systolic BP Change | -26.7 mmHg | Standard Deviation 20.9 |
Other Pre-specified
Urine Albumin to Creatinine Ratio
Time frame: 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Artery Ablation | Urine Albumin to Creatinine Ratio | 157.5 mg/g | Standard Deviation 609 |
Other Pre-specified
Urine Albumin to Creatinine Ratio
Time frame: 18 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Artery Ablation | Urine Albumin to Creatinine Ratio | 131.0 mg/g | Standard Deviation 358 |
Other Pre-specified
Urine Albumin to Creatinine Ratio
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Artery Ablation | Urine Albumin to Creatinine Ratio | 116.9 mg/g | Standard Deviation 421 |
Other Pre-specified
Urine Albumin to Creatinine Ratio
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Artery Ablation | Urine Albumin to Creatinine Ratio | 153.0 mg/g | Standard Deviation 454 |
Other Pre-specified
Urine Albumin to Creatinine Ratio
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Artery Ablation | Urine Albumin to Creatinine Ratio | 167.6 mg/g | Standard Deviation 493 |