Renal nerve stimulation: Renal nerve stimulation will be performed prior to and post renal denervation.
Study summary
The purpose of the Spyral InSight Early Clinical Feasibility Study is to characterize the physiological response to renal nerve stimulation (RNS) in humans prior to and post renal denervation.
Eligibility
Sex
ALL
Min age
20 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria:
1. 20 - 70 years of age
2. Office SBP ≥150 mmHg and \<180 mmHg and DBP ≥90 mmHg
3. Individual is prescribed with one, two, or three antihypertensive medication classes
4. 24-hour ABPM average of SBP ≥135 and \<170 mmHg at Baseline
Exclusion Criteria:
1. Prior renal denervation.
2. Individual lacks appropriate renal artery Anatomy
3. Has a renal artery stent
4. Individual has an estimated glomerular filtration rate (eGFR) of \<60 mL/min/1.73m2
5. Individual is taking SGLT2 inhibitors or GLP-1 agonists
6. Individual requires chronic oxygen support or mechanical ventilation
7. Primary pulmonary hypertension.
8. Secondary cause of hypertension
9. Pregnant, nursing or planning to become pregnant during the study.
10. Individual has a documented condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement
11. Individual is currently taking anti-mineralocorticoid drugs.
Primary outcome measure(s)
All-cause mortality — Through study completion, from enrollment to 12-month follow-up
End-stage renal disease — Through study completion, from enrollment to 12-month follow-up
Myocardial infarction — Through study completion, from enrollment to 12-month follow-up
Incidence of stroke — Through study completion, from enrollment to 12-month follow-up
Hospitalization for hypertensive crisis not related to non-adherence with medications — Through study completion, from enrollment to 12-month follow-up
Significant embolic event resulting in end-organ damage — Through study completion, from enrollment to 12-month follow-up
Renal artery intervention — Through study completion, from enrollment to 12-month follow-up
New renal artery stenosis >70%, confirmed by angiography and as determined by the angiographic core lab — Through study completion, from enrollment to 12-month follow-up
Vascular complications — Through study completion, from enrollment to 12-month follow-up
Major bleeding according to TIMI definition — Through study completion, from enrollment to 12-month follow-up
Prolonged renal vasoconstriction requiring intervention — Through study completion, from enrollment to 12-month follow-up
Contrast induced nephropathy — Through study completion, from enrollment to 12-month follow-up
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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