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Renal artery nerve interruption guided by location and electrical stimulation


- candidate number24218
- NTR NumberNTR5827
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-apr-2016
- Secondary IDsNL56394.029.16 (CCMO) 
- Public TitleRenal artery nerve interruption guided by location and electrical stimulation
- Scientific TitleRenal denerVatiOn under anatomicaL and elecTrical guidance
- ACRONYMVOLT
- hypothesisThe evidence for renal sympathetic denervation (RDN) in hypertensive patients is conflicting. Symplicity HTN-3, the only sham controlled study, proved negative although a modest overall effect of RDN is suggested. Today, no marker or functional test to guide RDN nor to establish a sufficient RDN procedure exists.
Recently, two intriguing observations have been accomplished. First, the distribution of renal sympathetic nerves in man has been studied, providing an anatomic map for denervation. Second, renal nerve stimulation (RNS) showed to induce a blood pressure increase in a human hypertension. The RNS-evoked increase was significantly blunted after RDN, thus providing an electrical map for denervation. Therefore it is hypothesized that anatomical and electrical stimulation guided and monitored renal denervation is superior compared to conventional renal denervation with respect to blood pressure reduction.
- Healt Condition(s) or Problem(s) studiedEssential hypertension
- Inclusion criteria- Essential hypertension
- Three antihypertensive drugs, of which one a diuretic
- Exclusion criteria- Age > 65 y
- Ambulantory blood pressure > 180/110 mmHg in the absence of antihypertensive medication
- Renal clearance < 60 ml/min (MDRD)
- Secundairy hypertension
- mec approval receivedno
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-jun-2016
- planned closingdate1-jun-2018
- Target number of participants20
- Interventions- renal nerve stimulation
- renal denervation
- hyperemic pressure and flow measurements
- Primary outcome- to study blood pressure changes in response to electrical stimulation pre- and post-ablation
- Secondary outcome- to study the effect of renal denervation on renal blood flow as expressed by renal flow reserve and resistance index. - to study the effect of renal denervation on office- and ambulatory blood pressure.
- to study the effect of renal denervation on the efferent sympathetic nervous system activity as expressed by catecholamine levels and natriuresis.
- to study the effect of RDN on central sympathetic nervous activity as expressed by heart rate variability and peripheral arterial tonometry.
- Timepointsall experiments will be performed during the index procedure and 3 months after (expect for renal denervation)
- Trial web site
- status[default]
- CONTACT FOR PUBLIC QUERIESMD, PhD. Alexander Nap
- CONTACT for SCIENTIFIC QUERIESMD, PhD. Alexander Nap
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
VU University Medical Center, St Jude Medical inc - Belgium
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD11-apr-2016 - 22-jun-2016


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