The principal aim of this study is the intraprocedural absence of blood pressure response to electrical stimulation post-ablation (as opposed to pre-ablation) in man in order to evaluate (effective) renal denervation.
ID
Source
Brief title
Condition
- Vascular hypertensive disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To study blood pressure changes in response to electrical stimulation pre- and
post-ablation in order to evaluate effective denervation.
Secondary outcome
To study the effect of renal denervation on office- and ambulatory blood
pressure.
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 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.
Background summary
Several years ago renal denervation was introduced as a promising intervention
in hypertension. The initial randomised trials proved positive. However, the
Symplicity HTN-3, the only randomized, sham controlled study, proved negative
although a modest overall effect of RDN is suggested.The evidence for renal
sympathetic denervation (RDN) in hypertensive patients is therefore
conflicting. Today, no marker or functional test to guide RDN nor to establish
sufficient renal denervation exists. Renal denervation can be considered as a
black box procedure.
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 model. The RNS-evoked increase was
significantly blunted after RDN, thus providing an electrical map for
denervation.
Study objective
The principal aim of this study is the intraprocedural absence of blood
pressure response to electrical stimulation post-ablation (as opposed to
pre-ablation) in man in order to evaluate (effective) renal denervation.
Study design
Pilot study, prospective open label.
Intervention
Anatomical and electrical stimulation guided renal denervation by means of
radiofrequency ablation of renal sympathetic nerves.
Hyperemic flow/pressure measurement within renal artery before and after
denervation
Heart rate variability measurements
Peripheral arterial tonometry
Study burden and risks
The extent of burden encompasses a regular diagnostic work-up for patients
presenting with hypertension including home blood pressure measurement, serum
and urine examination, echocardiography, abdominal CT and additional
percutaneous renal artery denervation.
Renal denervation has become an accepted therapeutic strategy with minimal
adverse events and patient discomfort.
Additional peri-procedural autonomic nerve stimulation, if potentially painful,
will be addressed with opioid treatment.
Peri-procedural (hyperemic) pressure/flow measurements bear minimal
risk/burden.
Patients will be sedated throughout the protocol.
Heart rate variability and peripheral arterial tonometry assesment encompasses
non-invasive measurements with a very limited additional burden.
The primary risks of the renal denervation / stimulation procedure are similar
to the risks of all diagnostic procedures requiring catheterization of the
arteries of the body. The following are potential risks of the catheterization
procedure:
- Complications at catheter insertion site in the groin (i.e., pain, bruising,
pseudo aneurysm, AV fistula, infection, significant external blood loss)
- Retroperitoneal bleeding
- Vascular complications requiring surgery
- Perforation or dissection of a blood vessel, such as the renal artery
- Temporary clotting (may cause heart attack, stroke or kidney damage and may
ultimately lead to incapacitation or death)
- Heart rhythm disturbances, such as a slowed heart rate
- Nausea or vomiting
- Athero-embolism resulting in distal vessel occlusion
- Complications associated with the contrast agent used during the procedure,
e.g., serious allergic reaction or contrast nephropathy
Risks acciciated especially to renal stimulation and denervation are mechanical
and sympathetic in origin. Possible effects are dissection and spasm, which can
most likely be treated conservative. Embolisation of microthrombi with or
without loss of renal function pose another small risk. Additionally,
(reversible) hypotension as a result of denervation can occur.
Boelelaan 1117
Amsterdam 1081HV
NL
Boelelaan 1117
Amsterdam 1081HV
NL
Listed location countries
Age
Inclusion criteria
Patients with evidence of hypertension, treated with at least three antihypertensive drug, 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)
secundaire hypertensie
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL56394.029.16 |
| OMON | NL-OMON23038 |