high blood pressure hypertension
Conditions
Interventions
Placed percutaneously, the Simplicity renal denervation catheter will be
advanced into the renal artery using a routine femoral artery approach in a
cardiac catheterization laboratory setting. Radio
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Age >=18 years; 2. Systolic blood pressure of 160 mmHg or more despite the use of at least three antihypertensive drugs (including one diuretic); 3. Presence of diastolic dysfunction at baseline in 50% of the population. 4. A glomerular filtration rate of 45ml/min/1.73m2 or more; 5. Written informed consent; 6. The patient agrees to the follow-up including the imaging modalities;
Exclusion criteria
Exclusion criteria: 1. Pregnancy; 2. Renal artery abnormalities; 3. Known secondary causes of hypertension with the exception of obstructive sleep apnea syndrome; 4. General MRI contra-indications (Appendix I); 5. The patient has other medical illness (i.e., cancer or congestive heart failure) that may cause the patient to be non-compliant with the protocol, confound the data interpretation or is associated with limited life expectancy (i.e., less than one year); 6. A mean systolic blood pressure of less than 135mmHg pre procedure by 24h ambulatory blood pressure measurement;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint: To assess the predictive value of arterial stiffness measured by MRI on the blood pressure response to renal artery denervation in patients with or without diastolic dysfunction using 24h ambulant blood pressure monitoring. Primary safety endpoint The occurrence of cardiovascular death, major access site bleeding, acute kidney injury and renal artery stenosis at 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate the change in arterial stiffness at baseline vs. 6 and 12 months post procedure. 2. To assess the impact of diastolic function using echo at baseline on the blood pressure response to renal artery denervation. 3. To assess the change in left ventricular volume and diastolic function following renal artery denervation. 4. To assess the change in renal perfusion at baseline vs. 6 and 12 months post procedure 5. To assess the change in blood pressure pre- vs. post procedure using 24h ambulatory blood pressure measurement. 6. Acute procedural safety (defined as the absence of peri-procedural safety endpoints) 7. The individual items of the primary safety endpoint. 8. Newly acquired renal artery stenosis and/or repeat renal artery intervention. 9. Development of renal failure and/or requirement of dialysis 10. Hospitalization for hypertensive emergency. | — |
Countries
Netherlands
Outcome results
None listed