SYMPATHY: Renal sympathetic denervation as a new treatment for therapy resistant hypertension: from rescue to resolve.

Withdrawn

Conditions: hoge bloeddruk
hypertension high blood pressure
10038430

Registration Number: NL-OMON37568

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 260

Inclusion Criteria

1.Individual has a mean daytime SBP >= 135 mmHg determined with the use of 24-h or daytime ambulatory BP monitoring while the individual uses antihypertensives.
2.Individual uses at least 3 antihypertensive drugs.
3.Individual is >=18 years of age.

Exclusion Criteria

1. Individual is unable or unwilling to sign informed consent
2. Individual has a treatable secondary cause of hypertension
3. Individual has an eGFR below 20mL/min/1.73m2 using the MDRD calculation
4. Individual has renal artery anatomy that is ineligible for treatment
5. 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
6. Individual is pregnant, nursing or planning to be pregnant.
7. Individual has a known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or would be unlikely or unable to comply with study follow-up requirements.
8. 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>The primary effectiveness endpoint is change in office BP at six months<br /><br>follow-up. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters/endpoints: Incidence of achieving target BP (SBP<br /><br><140 mmHg, or <130 for diabetics), incidence of achieving a >10 mmHg reduction<br /><br>in SBP, change in 24 hour ambulatory BP, change in eGFR, change in<br /><br>proteinuria/albuminuria, change in Quality of life, health care costs,<br /><br>non-healthcare costs and costs per Quality Adjusted Life Year. </p><br>