SPYRAL HTN-ON MED Study
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|ClinicalTrials.gov Identifier: NCT02439775|
Recruitment Status : Active, not recruiting
First Posted : May 12, 2015
Results First Posted : September 15, 2023
Last Update Posted : November 7, 2023
|Condition or disease||Intervention/treatment||Phase|
|Hypertension Vascular Diseases Cardiovascular Diseases||Device: Symplicity Spyral™ multi-electrode renal denervation system Procedure: Sham Procedure||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||337 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Global Clinical Study of Renal Denervation With the Symplicity Spyral™ Multi-electrode Renal Denervation System in Patients With Uncontrolled Hypertension on Standard Medical Therapy (SPYRAL HTN-ON MED)|
|Actual Study Start Date :||July 2015|
|Actual Primary Completion Date :||August 18, 2022|
|Estimated Study Completion Date :||October 2025|
Experimental: Renal Denervation
Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)
Device: Symplicity Spyral™ multi-electrode renal denervation system
After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
Sham Comparator: Sham Procedure
Procedure: Sham Procedure
After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.
Other Name: Renal angiography
- Acute and Chronic Safety by Evaluating Incidence of Major Adverse Events [ Time Frame: From baseline to 1 month post-procedure (6 months for new renal artery stenosis) ]The primary safety endpoint of the study is the incidence of Major Adverse Events (MAE), defined as a composite of the following events: All-cause mortality, End Stage Renal Disease (ESRD), Significant embolic event resulting in end-organ damage, Renal artery perforation requiring intervention, Renal artery dissection requiring intervention, Vascular complications, Hospitalization for hypertensive crisis not related to confirmed non-adherence with medications or the protocol, New renal artery stenosis >70%, confirmed by angiography and as a determined by the angiographic core laboratory, through one-month post-randomization (6- months for new renal artery stenosis).
- Change in Systolic Blood Pressure as Measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM) [ Time Frame: From baseline to 6 months post-procedure ]Baseline adjusted change (using Analysis of Covariance) in systolic blood pressure (SBP) from baseline (Screening Visit 2) to 6 months post-procedure as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM).
- Change in Office Systolic Blood Pressure [ Time Frame: From baseline to 6 months post-procedure ]Change in office systolic blood pressure from baseline (Screening Visit 2) to 6 months post-procedure
- Antihypertensive Medication Usage and Changes to 6-months [ Time Frame: From baseline to 6-month post-procedure ]Number of medications from baseline (Screening Visit 2) through 6 Months post-procedure
- Antihypertensive Medication Burden to 6-months [ Time Frame: From baseline to 6 Months post-procedure ]
Based on the prescribed medications reported, medication burden was calculated using Medication Index 2 score which is a composite index based on the doses of antihypertensive medications multiplied by the number of medications prescribed; all classes (ACE/ARB, calcium channel blockers, etc.) were considered equivalent in potency. Higher score indicates higher dosages being prescribed over the standard dose.
Minimum value 0; No Maximum value
- Medication Changes [ Time Frame: Baseline to 6-months post-procedure ]Patients who had medication changes based on Medication Index 2 drug testing data. Medication Index 2 score is a composite index based on the doses of antihypertensive medications multiplied by the number of medications prescribed; all classes (ACE/ARB, calcium channel blockers, etc.) were considered equivalent in potency.
- Incidence of Achieving Target Office Systolic Blood Pressure [ Time Frame: From baseline to 6 months post-procedure ]Incidence of achieving target office systolic blood pressure (SBP<140 mmHg) at 6 months post- procedure.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02439775
|Principal Investigator:||Raymond Townsend, MD||University of Pennsylvania|
|Principal Investigator:||David Kandzari, MD||Piedmont Hospital|
|Principal Investigator:||Michael Böhm, MD||Universitätskliniken des Saarlandes|
|Principal Investigator:||Kazuomi Kario, MD||Jichi Medical University|