N/A N=337 Randomized Single-blind Treatment

SPYRAL HTN-ON MED Study of Renal Denervation With the Symplicity Spyral™ Multi-electrode Renal Denervation System

Hypertension · Vascular Diseases · Cardiovascular Diseases

Bottom Line

View on ClinicalTrials.gov: NCT02439775 ↗

Enrolled (actual)

337

Serious AEs

9.8%

Results posted

Sep 2023

Primary outcome: Primary: Acute and Chronic Safety by Evaluating Incidence of Major Adverse Events — 204; 130; 2; 1 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Symplicity Spyral™ multi-electrode renal denervation system (Device); Sham Procedure (Procedure)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: Medtronic Vascular
Primary completion: Aug 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Acute and Chronic Safety by Evaluating Incidence of Major Adverse Events	204; 130; 2; 1	—
PRIMARY Change in Systolic Blood Pressure as Measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM)	-6.5; -4.5	0.1194
SECONDARY Change in Office Systolic Blood Pressure	-9.9; -5.1	—
SECONDARY Antihypertensive Medication Usage and Changes to 6-months	1.9; 1.9; 1.9; 2.1	—
SECONDARY Antihypertensive Medication Burden to 6-months	2.8; 3.0; 2.9; 3.5	—
SECONDARY Medication Changes	37; 35; 131; 80; 32; 13	—
SECONDARY Incidence of Achieving Target Office Systolic Blood Pressure	39; 8	—

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02439775). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.