SPYRAL PIVOTAL - SPYRAL HTN-OFF MED Study

Not Applicable

Completed

Conditions: Hypertension
Vascular Diseases
Cardiovascular Diseases

Registration Number: NCT02439749

Lead Sponsor: Medtronic Vascular

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 366

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of Participants With Major Adverse Events (MAE) Defined as a Composite of Events.	From baseline to 1 month post-procedure (6 months for new renal artery stenosis)	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)
Baseline Adjusted Change (Using Analysis of Covariance) in Systolic Blood Pressure as Measured by 24-hour Ambulatory Blood Pressure Monitoring	From baseline to 3 months post-procedure	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

Name	Time	Method
Number of Participants With Significant Embolic Event Resulting in End-organ Damage	From baseline to 1 month post-procedure	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	From baseline to 1 month post-procedure	Renal artery perforation requiring intervention
Renal Artery Dissection	From baseline to 1 month post-procedure	Number of Participants with Renal artery dissection requiring intervention
Number of Participants With Vascular Complications	From baseline to 1 month post-procedure	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	From baseline to 1 month post-procedure	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	From baseline to 1 month post-procedure	≥40% decline in eGFR
Myocardial Infarction	From baseline to 1 month post-procedure	Number of Participants with New myocardial infarction
Change in Office Systolic Blood Pressure	From baseline to 36 months post procedure	Change in Office Systiloc Blood Pressure From Baseline (Screening Visit 2) to 36 months.
Change in Office Diastolic Blood Pressure	From baseline to 36 months post-procedure	Change in office diastolic blood pressure
Number of Participants Achieving Target Office Systolic Blood Pressure	From baseline to 3 months post procedure	Incidence of Achieving Target Office Systolic Blood Pressure (SBP \<140 mmHg)
Number of Participants With ≥40% Decline in eGFR	From baseline to 36 months post randomization	≥40% Decline in eGFR
Number of Participants With Hospitalization for Hypertensive Crisis	From baseline to 36 months post randomization	Hospitalization for hypertensive crisis not related to confirmed non-adherence with medications orthe protocol
Change in Diastolic Blood Pressure as Measured by 24-hour ABPM	From baseline to 36 months post-procedure	Change in diastolic blood pressure as measured by 24-hour ABPM
Number of Participants With New Renal Artery Stenosis > 70%	From baseline to 36 months post randomization	Confirmed by angiography and as determined by the angiographic core laboratory.
Change in Systolic Blood Pressure as Measured by 24-hour ABPM	From baseline to 36 month post-procedure
Number of Participants With Incidence of Achieving Target Office Systolic Blood Pressure (SBP <140) mmHg)	From baseline to 36 months post-procedure
Number of Participants With New Stroke	From baseline to 36 months post randomization	New Stroke
New Stroke	From baseline to 3 months post randomization	Number of Participants with New Stroke
Number of Participants With Renal Artery Re-intervention	From baseline to 36 months post randomization	Renal Artery Re-intervention
Number of Participants With Major Bleeding According to TIMI Definition	From baseline to 36 months post randomization	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	From baseline to 1 month post-procedure	Increase in serum creatinine \> 50% from screening visit 2.
Number of Participants With Hospitalization for Hypertensive Crisis With Medications or the Protocol	From baseline to 1 month post-procedure	Hospitalization for hypertensive crisis not related to confirmed non-adherence with medications or the protocol.
Baseline Adjusted Change (Using Analysis of Covariance) in Office Systolic Blood Pressure	From baseline to 3 months post-procedure	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 All-cause Mortality	From baseline to 36 months post-randomization
Number of Participants With End-Stage Renal Disease (ESRD)	From baseline to 36 months post randomization	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 New Myocardial Infarction	From baseline to 36 months post randomization	New Myocardial Infarction
Increase in Serum Creatinine	From baseline to 3 months post randomization	Number of Participants with Increase in Serum Creatinine \> 50% from screening visit 2.
Number of Participants With an Increase in Serum Creatinine	From baseline to 36 months post randomization	Number of Participants with Increase in Serum Creatinine \> 50% from screening visit 2.

Trial Locations

Locations (47): Heart Center Research, LLC
🇺🇸
Huntsville, Alabama, United States
Honor Health Research Institute
🇺🇸
Scottsdale, Arizona, United States
Kaiser Permanente LA Medical Center
🇺🇸
Los Angeles, California, United States
Stanford Hospital and Clinics
🇺🇸
Stanford, California, United States
Yale New Haven Hospital
🇺🇸
New Haven, Connecticut, United States
Baptist Medical Center Jacksonville
🇺🇸
Jacksonville, Florida, United States
Tallahassee Research Institute
🇺🇸
Tallahassee, Florida, United States
Emory University Hospital Midtown
🇺🇸
Atlanta, Georgia, United States
Piedmont Heart Institute
🇺🇸
Atlanta, Georgia, United States
Iowa Heart Center
🇺🇸
West Des Moines, Iowa, United States
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Heart Center Research, LLC
🇺🇸Huntsville, Alabama, United States