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…
ID
Bron
Verkorte titel
Aandoening
Essential hypertension
Ondersteuning
St Jude Medical
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
- to study blood pressure changes in response to electrical stimulation pre- and post-ablation
Doel van het onderzoek
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.
Onderzoeksopzet
all experiments will be performed during the index procedure and 3 months after (expect for renal denervation)
Onderzoeksproduct en/of interventie
- renal nerve stimulation
- renal denervation
- hyperemic pressure and flow measurements
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Essential hypertension
- Three antihypertensive drugs, of which one a diuretic
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- Age > 65 y
- Ambulantory blood pressure > 180/110 mmHg in the absence of antihypertensive medication
- Renal clearance < 60 ml/min (MDRD)
- Secundairy hypertension
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL5683 |
NTR-old | NTR5827 |
CCMO | NL56394.029.16 |
OMON | NL-OMON46881 |