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SPYRAL PIVOTAL - SPYRAL HTN-OFF MED Study

Primary Purpose

Hypertension, Vascular Diseases, Cardiovascular Diseases

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Symplicity Spyral™ multi-electrode renal denervation system
Sham Procedure
Sponsored by
Medtronic Vascular
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Uncontrolled hypertension, Renal denervation

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Heart Center Research, LLC
  • Honor Health Research Institute
  • Kaiser Permanente LA Medical Center
  • Stanford Hospital and Clinics
  • Yale New Haven Hospital
  • Baptist Medical Center Jacksonville
  • Tallahassee Research Institute
  • Emory University Hospital Midtown
  • Piedmont Heart Institute
  • Iowa Heart Center
  • University of Kentucky
  • St Joseph Mercy Oakland
  • Providence Hospital
  • Minneapolis Heart Institute Foundation
  • Hattiesburg Clinic
  • Cardiology Associates Research LLC
  • Barnes-Jewish Hospital
  • Saint Barnabas Medical Center
  • North Shore University Hospital
  • Mount Sinai Medical Center
  • Duke University Medical Center
  • University Hospitals Cleveland Medical Center
  • PinnacleHealth Cardiovascular Institute
  • Hospital of the University of Pennsylvania
  • The Miriam Hospital
  • AnMed Health
  • Centennial Medical Center
  • Baylor Heart & Vascular Hospital
  • Charleston Area Medical Center
  • Aurora St. Luke's Medical Center
  • Alfred Hospital
  • Klinikum Wels-Grieskirchen
  • St. Michael's Hospital
  • Institut de cardiologie de Montréal / Montreal Heart Institute
  • Universitäts-Herzzentrum Freiburg - Bad Krozingen GmbH
  • Universitätsklinikum Erlangen
  • Universitätsklinikum des Saarlandes
  • Herzzentrum Leipzig, Universitätsklinik
  • Sana Kliniken Lübeck
  • Hippokration General Hospital of Athens
  • University General Hospital of Thessaloniki (AHEPA)
  • Galway University Hospital
  • Jichi Medical University Hospital
  • Mitsui Memorial Hospital
  • Cardiff and Vale University Health Board - University Hospital of Wales
  • Royal Devon & Exeter NHS Foundation Trust
  • Imperial College Healthcare NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Renal Denervation

Sham Procedure

Arm Description

Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)

Renal angiography

Outcomes

Primary Outcome Measures

Number of Participants With Major Adverse Events (MAE) Defined as a Composite of 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% (6 months for new renal artery stenosis, however endpoint data is reported to 3 months only)
Baseline Adjusted Change (Using Analysis of Covariance) in Systolic Blood Pressure as Measured by 24-hour Ambulatory Blood Pressure Monitoring
The outcome measure is the change in ambulatory systolic blood pressure from baseline to 3-month. The unadjusted treatment difference between renal denervation and sham control groups is -3.9 mmHg. The baseline adjusted treatment difference is -3.9 mmHg.

Secondary Outcome Measures

Baseline Adjusted Change (Using Analysis of Covariance) in Office Systolic Blood Pressure
The outcome measure is the change in office systolic blood pressure from baseline to 3-month. The unadjusted treatment difference between renal denervation and sham control groups is -7.0 mmHg. The baseline adjusted treatment difference is -6.9 mmHg.
Number of Participants With Significant Embolic Event Resulting in End-organ Damage
Significant embolic event resulting in end-organ damage (e.g. kidney/bowel infarct, lower extremity ulceration or gangrene, or doubling of serum creatinine documented by at least two measurements at least 21 days apart)
Number of Participants With Renal Artery Perforation Requiring Intervention
Renal artery perforation requiring intervention
Renal Artery Dissection
Number of Participants with Renal artery dissection requiring intervention
Number of Participants With Vascular Complications
Vascular complications (e.g., clinically significant groin hematoma, arteriovenous fistula, pseudoaneurysm, excessive bleeding) requiring surgical repair, interventional procedure, thrombin injection, or blood transfusion (requiring more than 2 units of packed red blood cells within any 24 hour period during the first 7 days post renal denervation procedure).
Number of Participants With End-stage Renal Disease
defined as two or more eGFR measurements < 15 mL/min/1.73m2 at least 21 days apart and requiring dialysis for one of more of the following: Volume management refractory to diuretics Hyperkalemia unmanageable by diet and diuretics Acidosis bicarbonate <18 unmanageable with HCO3 supplements Symptoms of uremia, nausea, vomiting
Number of Participants With Decline in eGFR
≥40% decline in eGFR
Myocardial Infarction
Number of Participants with New myocardial infarction
New Stroke
Number of Participants with New stroke
Number of Participants With Renal Artery Re-intervention
Renal artery re-intervention
Number of Participants With Major Bleeding According to TIMI Definition
Major bleeding according to TIMI definition (i.e. intracranial hemorrhage, ≥5g/dl decrease in hemoglobin concentration, a ≥15% absolute decrease in hematocrit, or death due to bleeding within 7 days of the procedure).
Number of Participants With Increase in Serum Creatinine
Increase in serum creatinine > 50% from screening visit 2.
Number of Participants With New Renal Artery Stenosis > 70%
Confirmed by angiography and as determined by the angiographic core laboratory.
Number of Participants With Hospitalization for Hypertensive Crisis With Medications or the Protocol
Hospitalization for hypertensive crisis not related to confirmed non-adherence with medications or the protocol.
Number of Participants With All-cause Mortality
All-cause mortality
Number of Participants With Change in Systolic Blood Pressure as Measured by 24-hour ABPM
Number of Participants With Incidence of Achieving Target Office Systolic Blood Pressure (SBP <140 mmHg)
Number of Participants With Change in Office Diastolic Blood Pressure
Change in office diastolic blood pressure
Number of Participants With Change in Diastolic Blood Pressure as Measured by 24-hour ABPM
Change in diastolic blood pressure as measured by 24-hour ABPM
Number of Participants With End-Stage Renal Disease (ESRD)
Defined as two or more eGFR measurements < 15 mL/min/1.73m2 at least 21 days apart and requiring dialysis for one of more of the following: Volume management refractory to diuretics Hyperkalemia unmanageable by diet and diuretics Acidosis bicarbonate <18 unmanageable with HCO3 supplements Symptoms of uremia, nausea, vomiting
Number of Participants With ≥40% Decline in eGFR
≥40% Decline in eGFR
Number of Participants With New Myocardial Infarction
New Myocardial Infarction
New Stroke
Number of Participants with New Stroke
Number of Participants With Renal Artery Re-intervention
Renal Artery Re-intervention
Number of Participants With Major Bleeding According to TIMI Definition
Major bleeding according to TIMI definition (i.e. intracranial hemorrhage, ≥5g/dl decrease in hemoglobin concentration, a ≥15% absolute decrease in hematocrit, or death due to bleeding within 7 days of the procedure).
Increase in Serum Creatinine
Number of Participants with Increase in Serum Creatinine > 50% from screening visit 2.
Number of Participants With Hospitalization for Hypertensive Crisis
Hospitalization for Hypertensive Crisis Not Related to Confirmed Nonadherence With Medications or the Protocol
Change in Office Systolic Blood Pressure
Change in office systolic blood pressure from baseline (Screening Visit 2) to 1-month
Number of Participants Achieving Target Office Systolic Blood Pressure
Incidence of achieving target office systolic blood pressure (SBP <140 mmHg)
Number of Participants Achieving Target Office Systolic Blood Pressure
Incidence of Achieving Target Office Systolic Blood Pressure (SBP <140 mmHg)
Change in Office Diastolic Blood Pressure
Change in office diastolic blood pressure from baseline (Screening Visit 2)
Change in Office Diastolic Blood Pressure
Change in Office Diastolic Blood Pressure From Baseline (Screening Visit 2) to 3-months
Change in Diastolic Blood Pressure as Measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM)
Change in diastolic blood pressure from baseline (screening visit 2) to 3-month as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM).

Full Information

First Posted
April 28, 2015
Last Updated
October 23, 2023
Sponsor
Medtronic Vascular
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1. Study Identification

Unique Protocol Identification Number
NCT02439749
Brief Title
SPYRAL PIVOTAL - SPYRAL HTN-OFF MED Study
Official Title
Global Clinical Study of Renal Denervation With the Symplicity Spyral™ Multi-electrode Renal Denervation System in Patients With Uncontrolled Hypertension in the Absence of Antihypertensive Medications (SPYRAL PIVOTAL - SPYRAL HTN-OFF MED)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 2015 (Actual)
Primary Completion Date
April 30, 2020 (Actual)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Vascular

4. Oversight

Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Vascular Diseases, Cardiovascular Diseases
Keywords
Uncontrolled hypertension, Renal denervation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
366 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Renal Denervation
Arm Type
Experimental
Arm Description
Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)
Arm Title
Sham Procedure
Arm Type
Sham Comparator
Arm Description
Renal angiography
Intervention Type
Device
Intervention Name(s)
Symplicity Spyral™ multi-electrode renal denervation system
Other Intervention Name(s)
Renal angiography, Renal Denervation
Intervention Description
After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
Intervention Type
Procedure
Intervention Name(s)
Sham Procedure
Other Intervention Name(s)
Renal angiography
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants With Major Adverse Events (MAE) Defined as a Composite of Events.
Description
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% (6 months for new renal artery stenosis, however endpoint data is reported to 3 months only)
Time Frame
From baseline to 1 month post-procedure
Title
Baseline Adjusted Change (Using Analysis of Covariance) in Systolic Blood Pressure as Measured by 24-hour Ambulatory Blood Pressure Monitoring
Description
The outcome measure is the change in ambulatory systolic blood pressure from baseline to 3-month. The unadjusted treatment difference between renal denervation and sham control groups is -3.9 mmHg. The baseline adjusted treatment difference is -3.9 mmHg.
Time Frame
From baseline to 3 months post-procedure
Secondary Outcome Measure Information:
Title
Baseline Adjusted Change (Using Analysis of Covariance) in Office Systolic Blood Pressure
Description
The outcome measure is the change in office systolic blood pressure from baseline to 3-month. The unadjusted treatment difference between renal denervation and sham control groups is -7.0 mmHg. The baseline adjusted treatment difference is -6.9 mmHg.
Time Frame
From baseline to 3 months post-procedure
Title
Number of Participants With Significant Embolic Event Resulting in End-organ Damage
Description
Significant embolic event resulting in end-organ damage (e.g. kidney/bowel infarct, lower extremity ulceration or gangrene, or doubling of serum creatinine documented by at least two measurements at least 21 days apart)
Time Frame
From baseline to 1 month post-procedure
Title
Number of Participants With Renal Artery Perforation Requiring Intervention
Description
Renal artery perforation requiring intervention
Time Frame
From baseline to 1 month post-procedure
Title
Renal Artery Dissection
Description
Number of Participants with Renal artery dissection requiring intervention
Time Frame
From baseline to 1 month post-procedure
Title
Number of Participants With Vascular Complications
Description
Vascular complications (e.g., clinically significant groin hematoma, arteriovenous fistula, pseudoaneurysm, excessive bleeding) requiring surgical repair, interventional procedure, thrombin injection, or blood transfusion (requiring more than 2 units of packed red blood cells within any 24 hour period during the first 7 days post renal denervation procedure).
Time Frame
From baseline to 1 month post-procedure
Title
Number of Participants With End-stage Renal Disease
Description
defined as two or more eGFR measurements < 15 mL/min/1.73m2 at least 21 days apart and requiring dialysis for one of more of the following: Volume management refractory to diuretics Hyperkalemia unmanageable by diet and diuretics Acidosis bicarbonate <18 unmanageable with HCO3 supplements Symptoms of uremia, nausea, vomiting
Time Frame
From baseline to 1 month post-procedure
Title
Number of Participants With Decline in eGFR
Description
≥40% decline in eGFR
Time Frame
From baseline to 1 month post-procedure
Title
Myocardial Infarction
Description
Number of Participants with New myocardial infarction
Time Frame
From baseline to 1 month post-procedure
Title
New Stroke
Description
Number of Participants with New stroke
Time Frame
From baseline to 1 month post-procedure
Title
Number of Participants With Renal Artery Re-intervention
Description
Renal artery re-intervention
Time Frame
From baseline to 1 month post-procedure
Title
Number of Participants With Major Bleeding According to TIMI Definition
Description
Major bleeding according to TIMI definition (i.e. intracranial hemorrhage, ≥5g/dl decrease in hemoglobin concentration, a ≥15% absolute decrease in hematocrit, or death due to bleeding within 7 days of the procedure).
Time Frame
From baseline to 1 month post-procedure
Title
Number of Participants With Increase in Serum Creatinine
Description
Increase in serum creatinine > 50% from screening visit 2.
Time Frame
From baseline to 1 month post-procedure
Title
Number of Participants With New Renal Artery Stenosis > 70%
Description
Confirmed by angiography and as determined by the angiographic core laboratory.
Time Frame
From baseline to 6 month post-procedure
Title
Number of Participants With Hospitalization for Hypertensive Crisis With Medications or the Protocol
Description
Hospitalization for hypertensive crisis not related to confirmed non-adherence with medications or the protocol.
Time Frame
From baseline to 1 month post-procedure
Title
Number of Participants With All-cause Mortality
Description
All-cause mortality
Time Frame
From baseline to 3 months post-procedure
Title
Number of Participants With Change in Systolic Blood Pressure as Measured by 24-hour ABPM
Time Frame
From baseline to 36 month post-procedure
Title
Number of Participants With Incidence of Achieving Target Office Systolic Blood Pressure (SBP <140 mmHg)
Time Frame
From 1 month to 36 months post-procedure
Title
Number of Participants With Change in Office Diastolic Blood Pressure
Description
Change in office diastolic blood pressure
Time Frame
From baseline to 36 months post-procedure
Title
Number of Participants With Change in Diastolic Blood Pressure as Measured by 24-hour ABPM
Description
Change in diastolic blood pressure as measured by 24-hour ABPM
Time Frame
From baseline to 36 months post-procedure
Title
Number of Participants With End-Stage Renal Disease (ESRD)
Description
Defined as two or more eGFR measurements < 15 mL/min/1.73m2 at least 21 days apart and requiring dialysis for one of more of the following: Volume management refractory to diuretics Hyperkalemia unmanageable by diet and diuretics Acidosis bicarbonate <18 unmanageable with HCO3 supplements Symptoms of uremia, nausea, vomiting
Time Frame
From baseline to 3 months post randomization
Title
Number of Participants With ≥40% Decline in eGFR
Description
≥40% Decline in eGFR
Time Frame
From baseline to 3 months post randomization
Title
Number of Participants With New Myocardial Infarction
Description
New Myocardial Infarction
Time Frame
From baseline to 3 months post randomization
Title
New Stroke
Description
Number of Participants with New Stroke
Time Frame
From baseline to 3 months post randomization
Title
Number of Participants With Renal Artery Re-intervention
Description
Renal Artery Re-intervention
Time Frame
From baseline to 3 months post randomization
Title
Number of Participants With Major Bleeding According to TIMI Definition
Description
Major bleeding according to TIMI definition (i.e. intracranial hemorrhage, ≥5g/dl decrease in hemoglobin concentration, a ≥15% absolute decrease in hematocrit, or death due to bleeding within 7 days of the procedure).
Time Frame
From baseline to 3 months post randomization
Title
Increase in Serum Creatinine
Description
Number of Participants with Increase in Serum Creatinine > 50% from screening visit 2.
Time Frame
From baseline to 3 months post randomization
Title
Number of Participants With Hospitalization for Hypertensive Crisis
Description
Hospitalization for Hypertensive Crisis Not Related to Confirmed Nonadherence With Medications or the Protocol
Time Frame
From baseline to 3 months post randomization
Title
Change in Office Systolic Blood Pressure
Description
Change in office systolic blood pressure from baseline (Screening Visit 2) to 1-month
Time Frame
From baseline to 1 month post procedure
Title
Number of Participants Achieving Target Office Systolic Blood Pressure
Description
Incidence of achieving target office systolic blood pressure (SBP <140 mmHg)
Time Frame
From baseline to 1 month post procedure
Title
Number of Participants Achieving Target Office Systolic Blood Pressure
Description
Incidence of Achieving Target Office Systolic Blood Pressure (SBP <140 mmHg)
Time Frame
From baseline to 3 months post procedure
Title
Change in Office Diastolic Blood Pressure
Description
Change in office diastolic blood pressure from baseline (Screening Visit 2)
Time Frame
From baseline to 1 month post procedure
Title
Change in Office Diastolic Blood Pressure
Description
Change in Office Diastolic Blood Pressure From Baseline (Screening Visit 2) to 3-months
Time Frame
From baseline to 3 months post procedure
Title
Change in Diastolic Blood Pressure as Measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM)
Description
Change in diastolic blood pressure from baseline (screening visit 2) to 3-month as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM).
Time Frame
From baseline to 3 months post procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raymond Townsend, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Kandzari, MD
Organizational Affiliation
Piedmont Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Böhm, MD
Organizational Affiliation
Universitätskliniken des Saarlandes
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kazuomi Kario, MD
Organizational Affiliation
Jichi Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Heart Center Research, LLC
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Honor Health Research Institute
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
Kaiser Permanente LA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Stanford Hospital and Clinics
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Baptist Medical Center Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Tallahassee Research Institute
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Emory University Hospital Midtown
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Piedmont Heart Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Iowa Heart Center
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
St Joseph Mercy Oakland
City
Pontiac
State/Province
Michigan
ZIP/Postal Code
48341
Country
United States
Facility Name
Providence Hospital
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48075
Country
United States
Facility Name
Minneapolis Heart Institute Foundation
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Hattiesburg Clinic
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39401
Country
United States
Facility Name
Cardiology Associates Research LLC
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Facility Name
Barnes-Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Saint Barnabas Medical Center
City
Livingston
State/Province
New Jersey
ZIP/Postal Code
07039
Country
United States
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
PinnacleHealth Cardiovascular Institute
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17011
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
The Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
AnMed Health
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Centennial Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Baylor Heart & Vascular Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75226
Country
United States
Facility Name
Charleston Area Medical Center
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25304
Country
United States
Facility Name
Aurora St. Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Klinikum Wels-Grieskirchen
City
Wels
ZIP/Postal Code
4600
Country
Austria
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
Institut de cardiologie de Montréal / Montreal Heart Institute
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
Facility Name
Universitäts-Herzzentrum Freiburg - Bad Krozingen GmbH
City
Bad Krozingen
ZIP/Postal Code
79189
Country
Germany
Facility Name
Universitätsklinikum Erlangen
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Universitätsklinikum des Saarlandes
City
Homburg
ZIP/Postal Code
66421
Country
Germany
Facility Name
Herzzentrum Leipzig, Universitätsklinik
City
Leipzig
ZIP/Postal Code
04289
Country
Germany
Facility Name
Sana Kliniken Lübeck
City
Lübeck
ZIP/Postal Code
23560
Country
Germany
Facility Name
Hippokration General Hospital of Athens
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
University General Hospital of Thessaloniki (AHEPA)
City
Thessaloniki
ZIP/Postal Code
54621
Country
Greece
Facility Name
Galway University Hospital
City
Galway
Country
Ireland
Facility Name
Jichi Medical University Hospital
City
Shimotsuke
State/Province
Tochigi
ZIP/Postal Code
329-0498
Country
Japan
Facility Name
Mitsui Memorial Hospital
City
Chiyoda
State/Province
Tokyo
ZIP/Postal Code
101-8643
Country
Japan
Facility Name
Cardiff and Vale University Health Board - University Hospital of Wales
City
Cardiff
Country
United Kingdom
Facility Name
Royal Devon & Exeter NHS Foundation Trust
City
Exeter
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Facility Name
Imperial College Healthcare NHS Trust
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
35852582
Citation
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Bohm M, Kario K, Kandzari DE, Mahfoud F, Weber MA, Schmieder RE, Tsioufis K, Pocock S, Konstantinidis D, Choi JW, East C, Lee DP, Ma A, Ewen S, Cohen DL, Wilensky R, Devireddy CM, Lea J, Schmid A, Weil J, Agdirlioglu T, Reedus D, Jefferson BK, Reyes D, D'Souza R, Sharp ASP, Sharif F, Fahy M, DeBruin V, Cohen SA, Brar S, Townsend RR; SPYRAL HTN-OFF MED Pivotal Investigators. Efficacy of catheter-based renal denervation in the absence of antihypertensive medications (SPYRAL HTN-OFF MED Pivotal): a multicentre, randomised, sham-controlled trial. Lancet. 2020 May 2;395(10234):1444-1451. doi: 10.1016/S0140-6736(20)30554-7. Epub 2020 Mar 29.
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SPYRAL PIVOTAL - SPYRAL HTN-OFF MED Study

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