hoge bloeddruk hypertension high blood pressure
Conditions
Interventions
The intervention group will, additional to usual care, be treated with RD.
Usual care is determined as therapy of hypertension in line with cardiovascular
disease prevention guidelines. The control
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary effectiveness endpoint is change in office BP at six months follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameters/endpoints: Incidence of achieving target BP (SBP 10 mmHg reduction in SBP, change in 24 hour ambulatory BP, change in eGFR, change in proteinuria/albuminuria, change in Quality of life, health care costs, non-healthcare costs and costs per Quality Adjusted Life Year. | — |
Countries
Netherlands
Outcome results
None listed