SPYRAL HTN-ON MED Study of Renal Denervation With the Symplicity Spyral™ Multi-electrode Renal Denervation System

Hypertension Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02439775
• Other study ID #: SPYRAL HTN-ON MED
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 2015
• Est. completion date: October 2025

Study information

• Verified date: April 2024
• Source: Medtronic Vascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test the hypothesis that renal denervation decreases blood pressure and is safe when studied in the presence of up to three standard antihypertensive medications.

Description:

The purpose of this study is to test the hypothesis that renal denervation is safe and reduces systolic blood pressure (SBP) in patients with uncontrolled hypertension on one, two, or three standard antihypertensive medications compared to a sham control in the same population. In this study, "uncontrolled hypertension" is defined as an office systolic blood pressure (SBP) ≥ 150 mmHg and <180 mmHg, an office Diastolic Blood Pressure (DBP) ≥90 mmHg and a 24-hour Ambulatory Blood Pressure Monitoring (ABPM) average SBP ≥140 mmHg to <170 mmHg, all of which are measured at Screening Visits. Data obtained will be used to confirm the effect of renal denervation on elevated blood pressure in patients on 1, 2 or 3 antihypertensive medications.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 337
• Est. completion date: October 2025
• Est. primary completion date: August 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Individual has office systolic blood pressure (SBP) = 150 mmHg and <180 mmHg and a diastolic blood pressure (DBP) = 90 mmHg when receiving a medication regimen of one, two, or three antihypertensive medication classes.
• Individual has 24-hour Ambulatory Blood Pressure Monitoring (ABPM) average SBP = 140 mmHg and < 170 mmHg.

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Hypertension
• Vascular Diseases

Intervention

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.

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.

Locations

Country	Name	City	State
Australia	St. George Hospital	Kogarah
Australia	Alfred Hospital	Melbourne	Victoria
Australia	Royal Perth	Perth
Austria	Klinikum Wels-Grieskirchen	Wels
Canada	Hamilton Heath	Hamilton	Ontario
Canada	St. Michael's Hospital	Toronto	Ontario
France	Clinique Pasteur	Toulouse
Germany	Universitäts-Herzzentrum Freiburg - Bad Krozingen GmbH	Bad Krozingen
Germany	Universitätsklinikum Erlangen	Erlangen
Germany	Universitätsklinikum des Saarlandes	Homburg
Germany	Herzzentrum Leipzig, Universitätsklinik	Leipzig
Germany	Sana Kliniken Lübeck	Lübeck
Greece	Hippokration General Hospital of Athens	Athens
Greece	University General Hospital of Thessaloniki (AHEPA)	Thessaloniki
Ireland	Galway University Hospital	Galway
Japan	Mitsui Memorial Hospital	Chiyoda	Tokyo
Japan	Shonan Kamakura General Hospital	Kamakura City	Okamoto
Japan	Saiseikai Nakatsu Hospital	Osaka
Japan	Jichi Medical University Hospital	Shimotsuke	Tochigi
Japan	Higashi Takarazuka Satoh Hospital	Takarazuka	Hyogo
United Kingdom	Royal Bournemouth Hospital	Bournemouth
United Kingdom	Cardiff and Vale University Health Board - University Hospital of Wales	Cardiff
United Kingdom	Royal Devon & Exeter NHS Foundation Trust	Exeter
United Kingdom	Imperial College Healthcare NHS Trust	London
United States	AnMed Health	Anderson	South Carolina
United States	Emory University Hospital Midtown	Atlanta	Georgia
United States	Piedmont Heart Institute	Atlanta	Georgia
United States	Charleston Area Medical Center	Charleston	West Virginia
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	Baylor Heart & Vascular Hospital	Dallas	Texas
United States	Duke University Medical Center	Durham	North Carolina
United States	PinnacleHealth Cardiovascular Institute	Harrisburg	Pennsylvania
United States	Hattiesburg Clinic	Hattiesburg	Mississippi
United States	Heart Center Research, LLC	Huntsville	Alabama
United States	Baptist Medical Center Jacksonville	Jacksonville	Florida
United States	Memorial Hospital Jacksonville	Jacksonville	Florida
United States	University of Kentucky	Lexington	Kentucky
United States	Saint Barnabas Medical Center	Livingston	New Jersey
United States	North Shore University Hospital	Manhasset	New York
United States	Aurora St. Luke's Medical Center	Milwaukee	Wisconsin
United States	Minneapolis Heart Institute Foundation	Minneapolis	Minnesota
United States	Centennial Medical Center	Nashville	Tennessee
United States	Yale New Haven Hospital	New Haven	Connecticut
United States	Mount Sinai Medical Center	New York	New York
United States	Weill Cornell Medical College/The New York Presbyterian Hospital	New York	New York
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	St Joseph Mercy Oakland	Pontiac	Michigan
United States	Oregon Health & Science University Hospital	Portland	Oregon
United States	The Miriam Hospital	Providence	Rhode Island
United States	Barnes-Jewish Hospital	Saint Louis	Missouri
United States	Providence Hospital	Southfield	Michigan
United States	Stanford Hospital and Clinics	Stanford	California
United States	Tallahassee Research Institute	Tallahassee	Florida
United States	Cardiology Associates Research LLC	Tupelo	Mississippi
United States	Washington DC VA Medical Center	Washington	District of Columbia
United States	Iowa Heart Center	West Des Moines	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Vascular

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Canada,  France,  Germany,  Greece,  Ireland,  Japan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute and Chronic Safety by Evaluating Incidence of Major Adverse Events	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).	From baseline to 1 month post-procedure (6 months for new renal artery stenosis)
Primary	Change in Systolic Blood Pressure as Measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM)	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).	From baseline to 6 months post-procedure
Secondary	Change in Office Systolic Blood Pressure	Change in office systolic blood pressure from baseline (Screening Visit 2) to 6 months post-procedure	From baseline to 6 months post-procedure
Secondary	Antihypertensive Medication Usage and Changes to 6-months	Number of medications from baseline (Screening Visit 2) through 6 Months post-procedure	From baseline to 6-month post-procedure
Secondary	Antihypertensive Medication Burden to 6-months	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	From baseline to 6 Months post-procedure
Secondary	Medication Changes	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.	Baseline to 6-months post-procedure
Secondary	Incidence of Achieving Target Office Systolic Blood Pressure	Incidence of achieving target office systolic blood pressure (SBP<140 mmHg) at 6 months post- procedure.	From baseline to 6 months post-procedure