The trial is taking place at:
B

Baptist Health | Baptist Medical Center Jacksonville

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

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Medtronic

Status

Active, not recruiting

Conditions

Hypertension
Cardiovascular Diseases
Vascular Diseases

Treatments

Device: Symplicity Spyral™ multi-electrode renal denervation system
Procedure: Sham Procedure

Study type

Interventional

Funder types

Industry

Identifiers

NCT02439775
SPYRAL HTN-ON MED

Details and patient eligibility

About

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.

Full description

The purpose of this study is to test the hypothesis that renal denervation is safe and reduces systolic blood pressure (SBP) in patients with uncontrolled hypertension on one, two, or three standard antihypertensive medications compared to a sham control in the same population. In this study, "uncontrolled hypertension" is defined as an office systolic blood pressure (SBP) ≥ 150 mmHg and <180 mmHg, an office Diastolic Blood Pressure (DBP) ≥90 mmHg and a 24-hour Ambulatory Blood Pressure Monitoring (ABPM) average SBP ≥140 mmHg to <170 mmHg, all of which are measured at Screening Visits. Data obtained will be used to confirm the effect of renal denervation on elevated blood pressure in patients on 1, 2 or 3 antihypertensive medications.

Enrollment

337 patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

337 participants in 2 patient groups

Renal Denervation
Experimental group
Description:
Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)
Treatment:
Device: Symplicity Spyral™ multi-electrode renal denervation system
Sham Procedure
Sham Comparator group
Description:
Renal angiography
Treatment:
Procedure: Sham Procedure

Trial documents
2

Trial contacts and locations

56

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Data sourced from clinicaltrials.gov

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