SYMPATHY: Renal sympathetic denervation as a new treatment for therapy resistant hypertension.
Phase 3
Completed
- Conditions
- hypertensiehigh blood pressurehypertension10038430
- Registration Number
- NL-OMON39831
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 570
Inclusion Criteria
1.Individual has an average 24-hour SBP of >= 130 mmHg or a mean day-time SBP >= 135 mmHg, as determined with the use of ABPM, while the patient uses 3 or more antihypertensive agents or with documented intolerance to 2 or more of the 4 major classes antihypertensive drugs
(ACE/ARB, Calcium channel blocker, Beta Blocker, Diuretic) and no possibility to take 3 anti-hypertensive drugs.
2.Individual is >=18 years of age.
Exclusion Criteria
1.Individual has a treatable secondary cause of hypertension
2.Individual has an eGFR below 1. Individual has a treatable secondary cause of hypertension 3.Individual has renal artery anatomy that is ineligible for treatment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint: change in ABPM (24-h or average day-time SBP).</p><br>
- Secondary Outcome Measures
Name Time Method <p>Key secondary study parameters/endpoints: 1)Change in the amount of<br /><br>antihypertensive medication (daily defined dose). 2) The effect of RD in<br /><br>subgroups: across strata of eGFR (eGFR 20-60 mL/min per 1.73m2 and eGFR>60<br /><br>mL/min per 1.73m2) and across strata of baseline BP (SBP 140-160mmHg and<br /><br>>160mmHg). 3)Change in office BP.</p><br>