SPYRAL PIVOTAL - SPYRAL HTN-OFF MED Study

Completed · Not applicable · Has a placebo group

Conditions studied: Hypertension, Vascular Diseases, Cardiovascular Diseases

In brief

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.

Key facts

Study ID

NCT02439749

Run by

Medtronic Vascular

People needed

366

Starts

2015-06-01

Expected to finish

2023-10-25

Last updated by the study team

2025-03-28

Who can join

Age: 20 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• University of Kentucky — Lexington, Kentucky, United States
• St Joseph Mercy Oakland — Pontiac, Michigan, United States
• Providence Hospital — Southfield, Michigan, United States
• Minneapolis Heart Institute Foundation — Minneapolis, Minnesota, United States
• Hattiesburg Clinic — Hattiesburg, Mississippi, United States
• Cardiology Associates Research LLC — Tupelo, Mississippi, United States
• Barnes-Jewish Hospital — St Louis, Missouri, United States
• Saint Barnabas Medical Center — Livingston, New Jersey, United States
• North Shore University Hospital — Manhasset, New York, United States
• Mount Sinai Medical Center — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• PinnacleHealth Cardiovascular Institute — Harrisburg, Pennsylvania, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• The Miriam Hospital — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.