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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02439775
Other study ID # SPYRAL HTN-ON MED
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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