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Source
Brief title
Health condition
Hypertension, Renal sympathetic denervation, Sprionolactone.
Hypertensie, Renale sympathische denervatie, spironolacton
Sponsors and support
Intervention
Outcome measures
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.
Study objective
Renal sympathetic denervation is not superior to add-on therapy with spironolactone in treatment-resistant hypertension.
Study design
Ambulatory blood pressure will be measured 6 months after intervention.
Intervention
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.
A.H. Meiracker, van den
's Gravendijkwal 230
Rotterdam 3015 CE
The Netherlands
+31-10-4639222
a.vandenmeiracker@erasmusmc.nl
A.H. Meiracker, van den
's Gravendijkwal 230
Rotterdam 3015 CE
The Netherlands
+31-10-4639222
a.vandenmeiracker@erasmusmc.nl
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;
6. Pregnancy;
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL3297 |
NTR-old | NTR3444 |
Other | METC Erasmus MC : MEC-2011-481 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |