The purpose of this study is to demonstrate the effectiveness of renal denervation in lowering blood pressure in patients with therapy-resistant hypertension and end-stage renal disease who are on dialysis or who have a renal transplant.
ID
Source
Brief title
Condition
- Renal disorders (excl nephropathies)
- Vascular hypertensive disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study outcome is the degree of blood pressure drop in 6 months after
renal denervation. Measurements will be performed with ambulatory blood
pressure measurement during 24 hours. Also changes in medication regimen will
be registered.
Secondary outcome
Effect of renal denervation on cardiac mass and function. Changes in sympatic
nerve activity measured by EMG of the nervus peroneus. Changes in hormonal
levels related to blood pressure regulation.
Background summary
The prevalence of end-stage renal failure is increasing. Hypertension is a
significant problem in patients with renal failure who are on dialysis or have
a renal transplant. 60 to 80% of these patients have hypertension. In a
significant proportion of these patients anti-hypertensive medication alone is
not sufficient to achieve acceptable blood pressures. Recent development of
new ablation catheters could be helpful in this. By inactivating the efferent
and afferent fibers of the sympathetic nervous system along the renal artery,
it may be possible to reduce the neurohormonal activity of the native kidneys
and with this a reduction of the blood pressure can be achieved.
Study objective
The purpose of this study is to demonstrate the effectiveness of renal
denervation in lowering blood pressure in patients with therapy-resistant
hypertension and end-stage renal disease who are on dialysis or who have a
renal transplant.
Study design
Single-centre, non-randomised, prospective cohort study.
Intervention
Renal denervation with an ablationcatheter. The renal arteries of the native
kidneys will be denervated.
Study burden and risks
Participants might benefit through a reduction in hypertension. This may result
in a decrease in number and / or amount of antihypertensive medication.
Hypertension has a detrimental long term effect on cardiac function. It can
lead to heart failure and myocardial hypertrophy. Lowering the blood pressure
results in reduced rates of cardiovascular events. So far, no long-term
effects of renal denervation are known.
Procedural complications can include the following:
Renal denervation can cause damage to the treated artery, resulting in an
occludion. However, this has no further consequences in this group of patients
since their native kidneys have no or hardly any residual function.
Furthermore, allergic reaction to the injected contrast or groin hematoma
caused by the puncture can occur.
Albert Schweitzerplaats 25
Dordrecht 3318AT
NL
Albert Schweitzerplaats 25
Dordrecht 3318AT
NL
Listed location countries
Age
Inclusion criteria
Patients with a renal transplant or on dialysis with therapy resistent hypertension, as defined in current guidelines (SBP >160 mmHg with the use of >=3 antihypertensive medication).
Exclusion criteria
Patient with a renal artery stent. Pregnant or pregnancy desire. Known allergy for iodine contrast. Age <18 year.
Patients with contraindication for MRI can participate. in these patients there will be no MRI examinations.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL42796.101.12 |