Renal Denervation in Patients with Uncontrolled Hypertension SYMPLICITY® HTN-2

Withdrawn

• Conditions: Hypertensie; Chronic kidney disease (or) chronic renal disease; high blood pressure; Hypertension; 10029149

• Registration Number: NL-OMON35153
• Lead Sponsor: Ardian, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

1. Individual has a systolic blood pressure higher than 160 mmHg (higher than 150 mmHg for type 2 diabetics).;2. Individual is adhering to a stable drug regimen including 3 or more antihypertensive medications (with no changes for a minimum of 2 weeks prior to enrollment) that is expected to be maintained for at least 6 months.;3. Individual is *18 and * 85 years of age.

Exclusion Criteria

1. Individual has anatomically abnormal renal artery (this is defined in detail in the study protocol on page 13).;2. Individual has an estimated glomerular filtration rate (eGFR) of < 45mL/min/1.73m2;3. Individual has type 1 diabetes mellitus.;4. Individual has experienced a myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within 6 months from the screening visit, or has widespread atherosclerosis.;5. Individual has a scheduled or planned surgery or cardiovascular intervention in the next 6 months.;6. Individual has hemodynamically significant valvular heart disease.;7. Individual has an implantable cardioverter defibrillator (ICD) or pacemaker, or any other metallic implant which is not compatible with MRI.;8. Individual has any serious medical condition, which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant or the study. ;9. Individual is pregnant, nursing or planning to be pregnant.;10. Individual has a known, unresolved history of drug use or alcohol dependency.;11. Individual is currently enrolled in another investigational drug or device trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Effect of kidney denervation on blood pressure from baseline to 6 months<br /><br>post-denervation.<br /><br><br /><br>Expected outcome:<br /><br>- Substantial decrease in blood pressure</p><br>