|- candidate number||12392|
|- NTR Number||NTR3444|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||21-mei-2012|
|- Secondary IDs||MEC-2011-481 METC Erasmus MC|
|- Public Title||Comparison of renal sympathetic denervation with spironolactone in patients with still a high blood pressure despite the use of 3 different antihypertensive agents.|
|- Scientific Title||Endovascular renal sympathetic denervation versus spironolactone in treatment-resistant hypertension: A randomized, multicentric study.|
|- hypothesis||Renal sympathetic denervation is not superior to add-on therapy with spironolactone in treatment-resistant hypertension.|
|- Healt Condition(s) or Problem(s) studied||Hypertension, Renal sympathetic denervation, Spironolactone|
|- Inclusion criteria||1. Age > 18 yrs and < 75 yrs;|
2. Treatment-resistent hypertension;
3. Willingness to give informed written consent.
|- Exclusion criteria||1. Secondary hypertension;|
2. Renal arteries inaccessible for endovascular denervation;
3. Suboptimal dosing of BP lowering medication;
4. Incompliant to treatment;
5. White coat hypertension;
7. GFR < 45 ml/min;
8. Use of vit K antagonist that can not be discontinued for a short period;
9. Sprinolactone intolerance;
10. Intolerance for one of the components of Exforge-Hydrochlorothiazidee;
11. Myocardial infarction or cerebrovascular accident 3 months prior to randomization;
12. Life expectancy< 2 year.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jun-2012|
|- planned closingdate||31-mei-2014|
|- Target number of participants||120|
|- Interventions||1. Endovascular renal sympathetic denervation;|
2. Addition of spironolactone to existing antihypertensive treatment.
The intervention consists either of endovascular renal sympathetic denervation or the addition of spironolactone to existing antihypertensive treatment.
Endovascular renal sympathetic denervation is a recently introduced technique. With the technique a catheter is introduced via a groin artery in the left and right renal artery.
Using radiofrequency energy the nerves surrounding the renal arteries are ablated. This a once a time procedure lasting about 1 hour. With this technique blood pressure potentially falls and this effect is compared with the addition of spironolactone in a maximal once daily dose of 50 mg.
Patients with treatment-resistant hypertension are included. They will be randomised for endovascular renal sympathetic denervation or treatment with spironolactone.
Spironolactone is used for 6 months. The primary endpoint of this study is the difference in 24-hour ambulatory blood pressure response between the group of patients treated with endovascular denervation and the group of patients treated with spironolactone after 6 months of follow-up.
|- Primary outcome||Difference in 24-hour ambulatory blood pressure between spironolactone and endovascular renal denervation 6 months after intervention.|
|- Secondary outcome||1. Proportion of patients with normalisation of ambulatory blood pressure in the two intervention groups;|
2. Proportion of patients per intervention group with a decrease in 24-hour ambulatory blood pressure of at least 10 mmHg systolic and and at least 5 mmHg diastolic;
3. Predictive value of clonidin-suppression test on blood pressure response to endovascular sympathetic denervation;
4. Cost effectiveness of renal sympathetic denervation;
5. Difference in quality of life score between endovascular renal denervation and spironolactone group.
|- Timepoints||Ambulatory blood pressure will be measured 6 months after intervention.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MD, PhD A.H. Meiracker, van den |
|- CONTACT for SCIENTIFIC QUERIES||MD, PhD A.H. Meiracker, van den |
|- Sponsor/Initiator ||Erasmus Medical Center, department of Radiology|
(Source(s) of Monetary or Material Support)
|Erasmus Medical Center, department of Radiology|
|- Publications||M. Ezzahti, A. Moelker, A.H. van den Meiracker: Endovascular renal sympathetic denervation. A new treatment for treatment resistant hypertension? Hart Bulletin 2012;43:34-39.|
|- Brief summary|
|- Main changes (audit trail)|
|- RECORD||21-mei-2012 - 20-jun-2012|