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Comparison of renal sympathetic denervation with spironolactone in patients with still a high blood pressure despite the use of 3 different antihypertensive agents.


- candidate number12392
- NTR NumberNTR3444
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-mei-2012
- Secondary IDsMEC-2011-481 METC Erasmus MC
- Public TitleComparison of renal sympathetic denervation with spironolactone in patients with still a high blood pressure despite the use of 3 different antihypertensive agents.
- Scientific TitleEndovascular renal sympathetic denervation versus spironolactone in treatment-resistant hypertension: A randomized, multicentric study.
- ACRONYMRRSS-trial
- hypothesisRenal sympathetic denervation is not superior to add-on therapy with spironolactone in treatment-resistant hypertension.
- Healt Condition(s) or Problem(s) studiedHypertension, Renal sympathetic denervation, Spironolactone
- Inclusion criteria1. Age > 18 yrs and < 75 yrs;
2. Treatment-resistent hypertension;
3. Willingness to give informed written consent.
- Exclusion criteria1. 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jun-2012
- planned closingdate31-mei-2014
- Target number of participants120
- Interventions1. 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 outcomeDifference in 24-hour ambulatory blood pressure between spironolactone and endovascular renal denervation 6 months after intervention.
- Secondary outcome1. 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.
- TimepointsAmbulatory blood pressure will be measured 6 months after intervention.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD, PhD A.H. Meiracker, van den
- CONTACT for SCIENTIFIC QUERIESMD, PhD A.H. Meiracker, van den
- Sponsor/Initiator Erasmus Medical Center, department of Radiology
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center, department of Radiology
- PublicationsM. 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)
- RECORD21-mei-2012 - 20-jun-2012


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