The primary objective is to study the effect of renal denervation on blood pressure in patients with uncontrolled hypertension 6 months after denervation. We hypothesize that there will be a substantial decrease in systolic blood pressure after…
ID
Source
Brief title
Condition
- Other condition
- Nephropathies
Synonym
Health condition
Hypertensie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Effect of kidney denervation on blood pressure from baseline to 6 months
post-denervation.
Expected outcome:
- Substantial decrease in blood pressure
Secondary outcome
- Safety (this is extensively described in the study protocol page 16)
o Acute Procedural Safety * to be compared against other common interventions
(renal stenting, angioplasty, etc.)
o 6 Month Safety *compared between groups at 6 months postrandomization eGFR
drop of >25%
o Composite Cardiovascular Endpoint * compared between groups at 6 months
post-randomization
-Blood pressure reduction:
o Incidence of achieving target SBP (SBP <140 mmHg, or <130 for diabetics) at 6
months post-randomization.
o Incidence of achieving a >10 mmHg reduction in SBP at 6 months
post-randomization.
o Incidence of high blood pressure actions and low blood pressure actions
through 6 months post-randomization.
o Change in Office Diastolic Blood Pressure (DBP) from baseline to 6 months
post-randomization
o Change in 24 hour ambulatory blood pressure from baseline to 6 months
post-randomization.
o Changes in SBP and DBP from baseline to 12, 18, 24, 30 & 36 months after
renal denervation.
- Left Ventricular (LV) Function: among patients with LV hypertrophy at
baseline, change in LV mass at 6 months following renal denervation.
Background summary
A set of pre-clinical studies have shown that renal denervation will decrease
blood pressure. The System delivers low-level radiofrequency energy through the
wall of the renal artery to denervate the human kidney. The catheter is
introduced using standard interventional technique via the femoral artery, and
is positioned in the renal artery under fluoroscopic guidance.The treatment
involves the delivery of relatively low-power and precisely focused RF bursts
of approximately 8W (contrasted with cardiovascular RF devices that generally
operate in excess of 30W) through the wall of the renal artery to disrupt the
surrounding renal nerves lying in the adventitia.
Study objective
The primary objective is to study the effect of renal denervation on blood
pressure in patients with uncontrolled hypertension 6 months after denervation.
We hypothesize that there will be a substantial decrease in systolic blood
pressure after denervation. The secondary objective is to study the safety of
renal denervation and blood pressure reduction during the follow up in this
population.
Study design
Patients who meet all inclusion criteria and no exclusion criteria will be
randomized into two groups: treatment group or control group. Every patient
will go under CT-scan of renal artery during screening phase.
Treatment group:
At the baseline: office blood pressure and 24 hour ambulatory blood pressure
will be measured. In addition, blood test and urine analysis will be performed
and patients will have a cardiac MRI-scan.
Within two week participants will undergo renal denervation procedure. The
office blood pressure will be measured and blood and urine analysis will be
repeated. Six and 12 months after denervation, in addition to regular blood
pressure and blood and urine tests also 24 hour ambulatory blood pressure will
be tested. Cardiac MRI will be repeated (only by patients with left ventricular
hypertrophy at the baseline). CT-scan of renal artery will be repeated once six
months after denervation). After a year patients will be asked to visit the
hospital every six months for office blood pressure readings during three years
of follow up.
Control group:
At the baseline: office blood pressure and 24 hour ambulatory blood pressure
will be measured. In addition, blood test and urine analysis will be performed
and patients will have a cardiac MRI-scan. No denervation procedure.
One and three month(s) later: blood pressure will be measured. In addition,
blood and urine analysis will be done.
Six months after the baseline: office blood pressure and 24 hour ambulatory
blood pressure will be measured. Blood and urine analysis will be repeated.
Cardiac MRI will be repeated only by patients with left ventricular hypertrophy
at the baseline.
Intervention
The treatment involves the delivery of relatively low-power and precisely
focused RF bursts of approximately 8W (contrasted with cardiovascular RF
devices that generally operate in excess of 30W) through the wall of the renal
artery to disrupt the surrounding renal nerves lying in the adventitia.
Study burden and risks
Risks associated to the procedure is extensively discussed in section E9.
The burden for the participants:
The procedure will take about an hour. During the first 6 months of the study
the participants should visit the hosptial every 3 months for controls. After 6
months the participants will be asked to visit our out-patient clinic every 6
months (these visits will be combined to their regular visits of our
out-patient clinic). During the study patients will undergo two CT-scans of the
renal artery and one cardiac MRI (only by patients with left ventricular
hypertrophy at the baseline).
1810A Embarcadero Road
Palo Alto, CA 94303
USA
1810A Embarcadero Road
Palo Alto, CA 94303
USA
Listed location countries
Age
Inclusion criteria
1. Individual has a systolic blood pressure higher than 160 mmHg (higher than 150 mmHg for type 2 diabetics).;2. Individual is adhering to a stable drug regimen including 3 or more antihypertensive medications (with no changes for a minimum of 2 weeks prior to enrollment) that is expected to be maintained for at least 6 months.;3. Individual is *18 and * 85 years of age.
Exclusion criteria
1. Individual has anatomically abnormal renal artery (this is defined in detail in the study protocol on page 13).;2. Individual has an estimated glomerular filtration rate (eGFR) of < 45mL/min/1.73m2;3. Individual has type 1 diabetes mellitus.;4. Individual has experienced a myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within 6 months from the screening visit, or has widespread atherosclerosis.;5. Individual has a scheduled or planned surgery or cardiovascular intervention in the next 6 months.;6. Individual has hemodynamically significant valvular heart disease.;7. Individual has an implantable cardioverter defibrillator (ICD) or pacemaker, or any other metallic implant which is not compatible with MRI.;8. Individual has any serious medical condition, which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant or the study. ;9. Individual is pregnant, nursing or planning to be pregnant.;10. Individual has a known, unresolved history of drug use or alcohol dependency.;11. Individual is currently enrolled in another investigational drug or device trial.
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 |
|---|---|
| Other | in de VS. Het NCT nummer voor TP-058 is NCT00888433. ClinicalTrials.gov |
| CCMO | NL28936.041.09 |