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ID
Source
Brief title
Health condition
Essential hypertension
Sponsors and support
St Jude Medical
Intervention
Outcome measures
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.
Study objective
The 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.
Study design
all experiments will be performed during the index procedure and 3 months after (expect for renal denervation)
Intervention
- renal nerve stimulation
- renal denervation
- hyperemic pressure and flow measurements
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
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5683 |
| NTR-old | NTR5827 |
| CCMO | NL56394.029.16 |
| OMON | NL-OMON46881 |