Hypertension
Conditions
Keywords
Hypertension, Renal Denervation
Brief summary
The REDUCE HTN: REINFORCE study is being conducted to determine whether the Vessix Reduce™ Catheter and Vessix™ Generator for the treatment of uncontrolled hypertension (off-treatment office systolic blood pressure ≥150 mmHg and ≤180 mmHg) shows acceptable performance at 8 weeks when compared to a masked procedure (renal angiogram).
Detailed description
Prospective, multicenter, single blinded, randomized, controlled, pilot study. Subjects will be randomized to renal denervation treatment or masked renal angiogram procedure (2:1).
Interventions
DEVICERenal Denervation (Vessix)
Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator
DEVICERenal Angiography
Percutaneous renal angiography
Sponsors
Boston Scientific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥18 and ≤75 years * OSBP ≥150 mmHg and ≤180 mmHg based on an average of 3 office-based blood pressure measurements * Average 24-hour ASBP ≥135 mmHg and ≤170 mmHg * For each kidney, a main renal artery, with or without accessory renal arteries, with diameter ≥3.0 mm and ≤7.0 mm and length ≥20.0 mm * Agrees to have all study procedures performed, and is competent and willing to provide written, informed consent
Exclusion criteria
* Stenosis \>30% or renal artery aneurysm in either renal artery * Fibromuscular dysplasia (FMD) * Known causes of secondary HTN * Type 1 diabetes mellitus * eGFR \<40 mL/min/1.73m2 * Known ejection fraction of \<30% or heart failure that required hospitalization in the previous 6 months * Severe valvular heart disease * ≥1 episode(s) of orthostatic hypotension not related to medication changes (reduction of SBP of ≥20 mmHg or DBP of ≥10 mmHg within three minutes of standing) coupled with symptoms within the past year or during screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| OBSERVATIONAL: Change (Mean Reduction) in Average 24-hour Ambulatory Systolic Blood Pressure (ASBP) Through 8 Weeks | Through 8 weeks | Change (mean reduction) in average 24-hour Ambulatory Systolic Blood Pressure (ASBP) through 8 weeks post randomization in subjects treated with renal denervation (Test) and subjects treated with masked procedure (Control) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Significant Embolic Event Resulting in End-organ Damage or Intervention to Prevent it | 4 weeks | Number of subjects experiencing a significant embolic event resulting in end-organ damage or intervention to prevent end-organ damage through 4 weeks. |
| Renal Artery Dissection or Perforation Requiring Intervention | 4 weeks | Number of renal artery dissection or perforation requiring intervention through 4 weeks. |
| Vascular Complications | 4 weeks | Number of vascular complications through 4 weeks. |
| Significant New Renal Artery Stenosis | 6 months | Number of significant new renal artery stenosis events through 6 months. |
| Number of Subjects Utilizing Anti-hypertensive Medications | 3 months | Number of subjects utilizing anti-hypertensive medications at 3 months. |
| Mean Reduction in Average 24-hour Ambulatory Systolic Blood Pressure at 6 Months | 6 Months | Change (mean reduction) in the average 24-hour ambulatory systolic blood pressure at 6 months compared to baseline |
| Mean Reduction in Average 24-hour Ambulatory Diastolic Blood Pressure Through 6 Months | 6 Months | Change (mean reduction) in average 24-hour ambulatory diastolic blood pressure at 6 months compared to baseline. |
| Mean Reduction in Average 24-Hour Ambulatory Systolic Blood Pressure | 12 Months | Mean Reduction in Average 24-Hour Ambulatory systolic blood pressure at 12 months |
| Mean Reduction in Average 24-hour Ambulatory Diastolic Blood Pressure | 12 Months | Mean reduction in average 24-hour ambulatory diastolic blood pressure at 12 months |
| Number of Hospitalizations Due to Severe Hypotension/Syncope | Through 6 months | Number of hospitalizations due to severe hypotension/syncope through 6 months. |
| Number of Participants With Renal Failure | 24 Months | Number of renal failure events through 24 months |
| Number of Participants With Hypertensive Crisis | 24 Months | Number of hypertensive crisis events through 24 months |
| Mean Reduction in Average Office-based Systolic Blood Pressure | 24 Months | Mean Reduction in Average office-based systolic blood pressure through 24 months |
| Mean Reduction in Average Office-based Diastolic Blood Pressure | 24 Months | Mean Reduction in Office-based diastolic blood pressure through 24 months |
| Percent of Subjects at Target Blood Pressure | 24 Months | Percent of subjects at target blood pressure through 24 months |
| Congestive Heart Failure | 24 Months | Number of subjects with congestive heart failure through 24 months |
| Myocardial Infarction | 24 Months | Number of subjects who experience myocardial infarction through 24 months |
| Stroke | 24 Months | Number of subjects experiencing stroke through 24 months |
| All-Cause Death | 24 Months | Number of all causes of death through 24 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Renal Denervation Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator (Vessix Renal Denervation System).
Renal Denervation (Vessix): Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator | 34 |
| Masked Procedure Percutaneous renal angiography
Renal Angiography: Percutaneous renal angiography | 17 |
| Total | 51 |
Baseline characteristics
| Characteristic | Renal Denervation | Total | Masked Procedure |
|---|---|---|---|
| Age, Continuous | 58.5 years STANDARD_DEVIATION 10.1 | 58.4 years STANDARD_DEVIATION 9.9 | 58.2 years STANDARD_DEVIATION 9.8 |
| Left Renal Accessory Artery | 5 Participants | 9 Participants | 4 Participants |
| Left Renal Artery | 34 Participants | 51 Participants | 17 Participants |
| Max Renal Artery Diameter | 6.3 mm STANDARD_DEVIATION 1.3 | 6.2 mm STANDARD_DEVIATION 1.3 | 6.1 mm STANDARD_DEVIATION 1.2 |
| Race/Ethnicity, Customized Asian | 2 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized Black, of African Heritage | 6 Participants | 9 Participants | 3 Participants |
| Race/Ethnicity, Customized Caucasian | 27 Participants | 41 Participants | 14 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 1 Participants | 2 Participants | 1 Participants |
| Reference Renal Artery Diameter | 5.4 mm STANDARD_DEVIATION 1.2 | 5.5 mm STANDARD_DEVIATION 1.1 | 5.5 mm STANDARD_DEVIATION 1.1 |
| Region of Enrollment United States | 34 participants | 51 participants | 17 participants |
| Renal Artery Length | 42.0 mm STANDARD_DEVIATION 17.8 | 43.6 mm STANDARD_DEVIATION 18 | 46.3 mm STANDARD_DEVIATION 18.3 |
| Right Renal Accessory Artery | 5 Participants | 11 Participants | 6 Participants |
| Right Renal Artery | 34 Participants | 51 Participants | 17 Participants |
| Sex: Female, Male Female | 16 Participants | 20 Participants | 4 Participants |
| Sex: Female, Male Male | 18 Participants | 31 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 17 |
| other Total, other adverse events | 27 / 34 | 13 / 17 |
| serious Total, serious adverse events | 5 / 34 | 5 / 17 |
Outcome results
Primary
OBSERVATIONAL: Change (Mean Reduction) in Average 24-hour Ambulatory Systolic Blood Pressure (ASBP) Through 8 Weeks
Change (mean reduction) in average 24-hour Ambulatory Systolic Blood Pressure (ASBP) through 8 weeks post randomization in subjects treated with renal denervation (Test) and subjects treated with masked procedure (Control)
Time frame: Through 8 weeks
Population: Number analyzed is based upon participants with a complete, valid Ambulatory Blood Pressure assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Denervation | OBSERVATIONAL: Change (Mean Reduction) in Average 24-hour Ambulatory Systolic Blood Pressure (ASBP) Through 8 Weeks | -5.3 mmHg | Standard Deviation 10.1 |
| Masked Procedure | OBSERVATIONAL: Change (Mean Reduction) in Average 24-hour Ambulatory Systolic Blood Pressure (ASBP) Through 8 Weeks | -8.5 mmHg | Standard Deviation 9.4 |
Secondary
All-Cause Death
Number of all causes of death through 24 months
Time frame: 24 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Renal Denervation | All-Cause Death | 0 Participants |
| Masked Procedure | All-Cause Death | 0 Participants |
Secondary
Congestive Heart Failure
Number of subjects with congestive heart failure through 24 months
Time frame: 24 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Renal Denervation | Congestive Heart Failure | 1 Participants |
| Masked Procedure | Congestive Heart Failure | 0 Participants |
Secondary
Mean Reduction in Average 24-hour Ambulatory Diastolic Blood Pressure
Mean reduction in average 24-hour ambulatory diastolic blood pressure at 12 months
Time frame: 12 Months
Population: Number analyzed is based upon participants with a complete, valid Ambulatory Blood Pressure assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Denervation | Mean Reduction in Average 24-hour Ambulatory Diastolic Blood Pressure | -11.0 mmHg | Standard Deviation 9.8 |
| Masked Procedure | Mean Reduction in Average 24-hour Ambulatory Diastolic Blood Pressure | -9.0 mmHg | Standard Deviation 5.7 |
Secondary
Mean Reduction in Average 24-hour Ambulatory Diastolic Blood Pressure Through 6 Months
Change (mean reduction) in average 24-hour ambulatory diastolic blood pressure at 6 months compared to baseline.
Time frame: 6 Months
Population: Number analyzed is based upon participants with a complete, valid Ambulatory Blood Pressure assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Denervation | Mean Reduction in Average 24-hour Ambulatory Diastolic Blood Pressure Through 6 Months | -9.1 mmHg | Standard Deviation 8.3 |
| Masked Procedure | Mean Reduction in Average 24-hour Ambulatory Diastolic Blood Pressure Through 6 Months | -5.5 mmHg | Standard Deviation 8.2 |
Secondary
Mean Reduction in Average 24-Hour Ambulatory Systolic Blood Pressure
Mean Reduction in Average 24-Hour Ambulatory systolic blood pressure at 12 months
Time frame: 12 Months
Population: Number analyzed is based upon participants with a complete, valid Ambulatory Blood Pressure assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Denervation | Mean Reduction in Average 24-Hour Ambulatory Systolic Blood Pressure | -18.2 mmHg | Standard Deviation 14.3 |
| Masked Procedure | Mean Reduction in Average 24-Hour Ambulatory Systolic Blood Pressure | -14.3 mmHg | Standard Deviation 8.4 |
Secondary
Mean Reduction in Average 24-hour Ambulatory Systolic Blood Pressure at 6 Months
Change (mean reduction) in the average 24-hour ambulatory systolic blood pressure at 6 months compared to baseline
Time frame: 6 Months
Population: Number analyzed is based upon participants with a complete, valid Ambulatory Blood Pressure assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Denervation | Mean Reduction in Average 24-hour Ambulatory Systolic Blood Pressure at 6 Months | -16.7 mmHg | Standard Deviation 13.6 |
| Masked Procedure | Mean Reduction in Average 24-hour Ambulatory Systolic Blood Pressure at 6 Months | -9.5 mmHg | Standard Deviation 11.4 |
Secondary
Mean Reduction in Average Office-based Diastolic Blood Pressure
Mean Reduction in Office-based diastolic blood pressure through 24 months
Time frame: 24 Months
Population: Number analyzed is based upon participants with a completed Office-Based Systolic Blood Pressure assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Denervation | Mean Reduction in Average Office-based Diastolic Blood Pressure | -9.5 mmHg | Standard Deviation 10.3 |
| Masked Procedure | Mean Reduction in Average Office-based Diastolic Blood Pressure | -9.8 mmHg | Standard Deviation 12.5 |
Secondary
Mean Reduction in Average Office-based Systolic Blood Pressure
Mean Reduction in Average office-based systolic blood pressure through 24 months
Time frame: 24 Months
Population: Number analyzed is based upon participants with a completed Office-Based Systolic Blood Pressure assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Denervation | Mean Reduction in Average Office-based Systolic Blood Pressure | -19.7 mmHg | Standard Deviation 18.9 |
| Masked Procedure | Mean Reduction in Average Office-based Systolic Blood Pressure | -25.7 mmHg | Standard Deviation 21.2 |
Secondary
Myocardial Infarction
Number of subjects who experience myocardial infarction through 24 months
Time frame: 24 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Renal Denervation | Myocardial Infarction | 0 Participants |
| Masked Procedure | Myocardial Infarction | 0 Participants |
Secondary
Number of Hospitalizations Due to Severe Hypotension/Syncope
Number of hospitalizations due to severe hypotension/syncope through 6 months.
Time frame: Through 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Renal Denervation | Number of Hospitalizations Due to Severe Hypotension/Syncope | 0 Participants |
| Masked Procedure | Number of Hospitalizations Due to Severe Hypotension/Syncope | 0 Participants |
Secondary
Number of Participants With Hypertensive Crisis
Number of hypertensive crisis events through 24 months
Time frame: 24 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Renal Denervation | Number of Participants With Hypertensive Crisis | 1 Participants |
| Masked Procedure | Number of Participants With Hypertensive Crisis | 0 Participants |
Secondary
Number of Participants With Renal Failure
Number of renal failure events through 24 months
Time frame: 24 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Renal Denervation | Number of Participants With Renal Failure | 2 Participants |
| Masked Procedure | Number of Participants With Renal Failure | 0 Participants |
Secondary
Number of Subjects Utilizing Anti-hypertensive Medications
Number of subjects utilizing anti-hypertensive medications at 3 months.
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Renal Denervation | Number of Subjects Utilizing Anti-hypertensive Medications | 16 Participants |
| Masked Procedure | Number of Subjects Utilizing Anti-hypertensive Medications | 9 Participants |
Secondary
Number of Subjects Utilizing Anti-hypertensive Medications
Number of subjects utilizing anti-hypertensive medications at 6 months
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Renal Denervation | Number of Subjects Utilizing Anti-hypertensive Medications | 26 Participants |
| Masked Procedure | Number of Subjects Utilizing Anti-hypertensive Medications | 14 Participants |
Secondary
Percent of Subjects at Target Blood Pressure
Percent of subjects at target blood pressure through 24 months
Time frame: 24 Months
Population: Number analyzed is based upon participants with a completed Office-Based Systolic Blood Pressure assessment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Renal Denervation | Percent of Subjects at Target Blood Pressure | 12 Participants |
| Masked Procedure | Percent of Subjects at Target Blood Pressure | 5 Participants |
Secondary
Renal Artery Dissection or Perforation Requiring Intervention
Number of renal artery dissection or perforation requiring intervention through 4 weeks.
Time frame: 4 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Renal Denervation | Renal Artery Dissection or Perforation Requiring Intervention | 0 Participants |
| Masked Procedure | Renal Artery Dissection or Perforation Requiring Intervention | 0 Participants |
Secondary
Significant Embolic Event Resulting in End-organ Damage or Intervention to Prevent it
Number of subjects experiencing a significant embolic event resulting in end-organ damage or intervention to prevent end-organ damage through 4 weeks.
Time frame: 4 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Renal Denervation | Significant Embolic Event Resulting in End-organ Damage or Intervention to Prevent it | 0 Participants |
| Masked Procedure | Significant Embolic Event Resulting in End-organ Damage or Intervention to Prevent it | 0 Participants |
Secondary
Significant New Renal Artery Stenosis
Number of significant new renal artery stenosis events through 6 months.
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Renal Denervation | Significant New Renal Artery Stenosis | 0 Participants |
| Masked Procedure | Significant New Renal Artery Stenosis | 0 Participants |
Secondary
Stroke
Number of subjects experiencing stroke through 24 months
Time frame: 24 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Renal Denervation | Stroke | 0 Participants |
| Masked Procedure | Stroke | 0 Participants |
Secondary
Vascular Complications
Number of vascular complications through 4 weeks.
Time frame: 4 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Renal Denervation | Vascular Complications | 0 Participants |
| Masked Procedure | Vascular Complications | 0 Participants |