uncontrolled hypertension
Conditions
Interventions
See Table 1. Schedule of Treatments and Assessments CIP version 2.0
The SPYRAL DYSTAL study is a multi-center, international, prospective,
interventional, single arm study designed to study renal de
therefore, approximately 350 subjects will be enrolled to
ensure approximately 50 hypertensive subjects will undergo the renal
denervation procedure at up to 10 sites. Once enrolled, subjects will u
Sponsors
Medtronic Trading NL BV
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Individual is * 20 and * 80 years old at time of enrollment (consent). 2. Individual has an office systolic blood pressure (SBP) * 150 mmHg and
Exclusion criteria
Exclusion criteria: 1. Individual has one or more of the following conditions: 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. Patients are permitted to take aspirin or clopidogrel for cardiovascular risk reduction. Patients who received catheter or surgical treatment for Atrial Fibrillation and are in sinus rhythm are not excluded. 2. Individual has undergone prior renal denervation. 3. Individual has at least one main renal artery with a diameter of less than 3mm or greater than 8mm. 4. Presence of FMD (defined as visible beading of the artery on angiography). 5. Has >50% stenosis in any treatable vessel. 6. Has a renal artery stent placed 3 months old (from the date of Screening Visit 2), or history of uncontrolled blood sugars raises concern, it is required to analyze glycosylated hemoglobin as part of Screening Visit 2 labs.) 11. Individual is taking SGLT2 inhibitor or GLP-1 agonists that have been prescribed <90 days prior to SV1 or who does not plan on remaining on these drugs for the duration of the trial. 12. Individual has had *1 episode(s) of orthostatic hypotension not related to medication changes within the past year or has a reduction of SBP *20 mmHg or DBP *10 mmHg within 3 minutes of standing coupled with symptoms during the screening process (at SV2). 13. Individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea (e.g. CPAP, BiPAP). 14. Individual with a history of narcotic drug abuse, is currently on Methadone, or who has used narcotic drugs more than once in the month prior to Screening Visit 1. 15. Individual had documented primary pulmonary hypertension. 16. Individual has untreated secondary cause of hypertension (either known or suspected) or is taking drugs that increase sympathetic tone that could contribute to hypertension. 17. Individual has frequent intermittent or chronic pain that results in treatment with non-steroidal anti-inflammatory drugs (NSAIDs) for two or more days per week over the month prior to Screening Visit 2. 18. Individual with HIV on anti-retroviral drug therapy without documentation that hypertension preceded initiation of anti-retroviral drug treatment. 19. Individual has a scheduled or planned surgery that, in the opinion of the Investigator, may affect study endpoints. 20. Individual has a documented condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement using the protocol-specified automatic/offi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy endpoints The efficacy endpoints will be compared to the SPYRAL HTN-OFF MED efficacy endpoints using a propensity score stratified analysis at 3 months. At 6 months and 12 months, the endpoints will be analyzed within the SPYRAL DYSTAL study only. * Change in systolic blood pressure (SBP) from baseline (Screening Visit 2) to 3, 6 and 12 months post-procedure as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM). * Change in office SBP from baseline (Screening Visit 2) to 3, 6, and 12 months post-procedure. * Change in diastolic blood pressure (DBP) from baseline (Screening Visit 2) to 3, 6, and 12 months post-procedure as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM). * Change in office DBP from baseline (Screening Visit 2) to 3, 6, and 12 months post-procedure. * Incidence of achieving target office SBP (SBP | — |
Secondary
| Measure | Time frame |
|---|---|
| see above section | — |
Countries
Netherlands
Outcome results
None listed