N/A
N=366
SPYRAL PIVOTAL - SPYRAL HTN-OFF MED Study
Hypertension · Vascular Diseases · Cardiovascular Diseases
Bottom Line
View on ClinicalTrials.gov: NCT02439749 ↗Enrolled (actual)
366
Serious AEs
20.2%
Results posted
May 2021
Primary outcome: Primary: Number of Participants With Major Adverse Events (MAE) Defined as a Composite of Events. — 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Symplicity Spyral™ multi-electrode renal denervation system (Device); Sham Procedure (Procedure)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Medtronic Vascular
- Primary completion
- Apr 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Major Adverse Events (MAE) Defined as a Composite of Events. |
0; 0 | — |
| PRIMARY Baseline Adjusted Change (Using Analysis of Covariance) in Systolic Blood Pressure as Measured by 24-hour Ambulatory Blood Pressure Monitoring |
-4.5; -0.6 | — |
| SECONDARY Number of Participants With Significant Embolic Event Resulting in End-organ Damage |
0; 0 | — |
| SECONDARY Number of Participants With Renal Artery Perforation Requiring Intervention |
0; 0 | — |
| SECONDARY Renal Artery Dissection |
0; 0 | — |
| SECONDARY Number of Participants With Vascular Complications |
0; 1 | — |
| SECONDARY Number of Participants With End-stage Renal Disease |
0; 0 | — |
| SECONDARY Number of Participants With Decline in eGFR |
0; 0 | — |
| SECONDARY Myocardial Infarction |
0; 0 | — |
| SECONDARY New Stroke |
0; 1 | — |
| SECONDARY Number of Participants With Renal Artery Re-intervention |
0; 0 | — |
| SECONDARY Number of Participants With Major Bleeding According to TIMI Definition |
0; 2 | — |
| SECONDARY Number of Participants With Increase in Serum Creatinine |
1; 0 | — |
| SECONDARY Number of Participants With Hospitalization for Hypertensive Crisis With Medications or the Protocol |
0; 0 | — |
| SECONDARY Change in Office Systolic Blood Pressure |
-21.9; -26.4 | 0.070 |
| SECONDARY Change in Office Diastolic Blood Pressure |
-10.8; -15.4 | 0.009 sig |
| SECONDARY Number of Participants Achieving Target Office Systolic Blood Pressure |
27; 12 | — |
| SECONDARY Baseline Adjusted Change (Using Analysis of Covariance) in Office Systolic Blood Pressure |
-9.4; -2.3 | — |
| SECONDARY Number of Participants With All-cause Mortality |
0; 1 | — |
| SECONDARY Number of Participants With ≥40% Decline in eGFR |
1; 0 | — |
| SECONDARY Number of Participants With End-Stage Renal Disease (ESRD) |
0; 0 | — |
| SECONDARY Number of Participants With New Myocardial Infarction |
0; 0 | — |
| SECONDARY New Stroke |
0; 1 | — |
| SECONDARY Number of Participants With Renal Artery Re-intervention |
0; 0 | — |
| SECONDARY Number of Participants With Major Bleeding According to TIMI Definition |
0; 2 | — |
| SECONDARY Increase in Serum Creatinine |
0; 0 | — |
| SECONDARY Number of Participants With Hospitalization for Hypertensive Crisis |
1; 2 | — |
| SECONDARY Change in Diastolic Blood Pressure as Measured by 24-hour ABPM |
-11.7; -15.0 | 0.052 |
| SECONDARY Change in Office Diastolic Blood Pressure |
-10.8; -15.4 | 0.009 sig |
| SECONDARY Number of Participants Achieving Target Office Systolic Blood Pressure |
27; 12 | — |
| SECONDARY Number of Participants With New Renal Artery Stenosis > 70% |
0; 0 | — |
| SECONDARY Change in Systolic Blood Pressure as Measured by 24-hour ABPM |
-16.2; -22.0 | 0.026 sig |
| SECONDARY Change in Diastolic Blood Pressure as Measured by 24-hour ABPM |
-11.7; -15.0 | 0.052 |
| SECONDARY Change in Office Systolic Blood Pressure |
-21.9; -26.4 | 0.070 |
| SECONDARY Change in Office Diastolic Blood Pressure |
-10.8; -15.4 | 0.009 sig |
| SECONDARY Number of Participants With Incidence of Achieving Target Office Systolic Blood Pressure (SBP <140) mmHg) |
70; 33 | — |
| SECONDARY Number of Participants With All-cause Mortality |
0; 1 | — |
| SECONDARY Number of Participants With End-Stage Renal Disease (ESRD) |
0; 0 | — |
| SECONDARY Number of Participants With ≥40% Decline in eGFR |
1; 0 | — |
| SECONDARY Number of Participants With New Myocardial Infarction |
0; 0 | — |
| SECONDARY Number of Participants With New Stroke |
0; 3 | — |
| SECONDARY Number of Participants With Renal Artery Re-intervention |
0; 0 | — |
| SECONDARY Number of Participants With Major Bleeding According to TIMI Definition |
0; 2 | — |
| SECONDARY Number of Participants With an Increase in Serum Creatinine |
1; 0 | — |
| SECONDARY Number of Participants With New Renal Artery Stenosis > 70% |
0; 0 | — |
| SECONDARY Number of Participants With Hospitalization for Hypertensive Crisis |
1; 2 | — |
Summary
The purpose of this study is to test the hypothesis that renal denervation decreases blood pressure and is safe when studied in the absence of antihypertensive medications.
Eligibility Criteria
Inclusion Criteria
- Individual has office systolic blood pressure (SBP) ≥ 150 mmHg and <180 mmHg and a diastolic blood pressure (DBP) ≥ 90 mmHg after being off medications.
- Individual has 24-hour Ambulatory Blood Pressure Monitoring (ABPM) average SBP ≥ 140 mmHg and < 170 mmHg.
- Individual is willing to discontinue current antihypertensive medications.
Exclusion Criteria
- Individual lacks appropriate renal artery anatomy.
- Individual has estimated glomerular filtration rate (eGFR) of <45.
- Individual has type 1 diabetes mellitus or poorly-controlled type 2 diabetes mellitus.
- Individual has one or more episodes of orthostatic hypotension.
- Individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea.
- Individual has primary pulmonary hypertension.
- Individual is pregnant, nursing or planning to become pregnant.
- Individual has frequent intermittent or chronic pain that results in treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) for two or more days per week over the month prior to enrollment.
- Individual has stable or unstable angina within 3 months of enrollment, myocardial infarction within 3 months of enrollment; heart failure, cerebrovascular accident or transient ischemic attack, or atrial fibrillation at any time.
- Individual works night shifts.
Data sourced from ClinicalTrials.gov (NCT02439749). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.