Clinical trial NCT01762488: Renal Denervation in Treatment Resistant Hypertension
Official title: Renal Denervation in Treatment Resistant Hypertension, a Double-blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Hypertension
Keywords: Treatment Resistant Hypertension
Renal Denervation
Lead sponsor: Aarhus University Hospital Skejby
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: Regionshospitalet Silkeborg
name: Randers Regional Hospital
name: Central Jutland Regional Hospital
name: Regional Hospital Holstebro
First posted: 2013-01-07
Enrollment: 8
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this double-blind, randomized and sham controlled study is to investigate the blood pressure lowering effect of renal denervation by catheter based ablation in the renal arteries in patients with milder forms of treatment resistant hypertension. The effect on blood pressure will be evaluated by 24-hour ambulatory blood pressure measurements at baseline and after 3 and 6 months of follow up. Secondary endpoint evaluation comprises hemodynamic assessment by applanation tonometry and the cold pressor response.


Eligibility criteria: Inclusion Criteria:

* Systolic daytime (24 hour-ambulatory blood pressure measurement) \> 135 mmHg and \< 145 mmHg.
* Stable (for at least 1 month and with no planned changes for the next 6 months) antihypertensive therapy with at least 3 antihypertensive drugs, including a diuretic.
* Documented adherence to present antihypertensive therapy

Exclusion Criteria:

* Pregnancy
* Non compliance
* Heart failure (NYHA Class III-IV)
* LV ejection fraction \< 50 %
* Renal insufficiency (eGFR\<30 ml/min)
* Unstable coronary heart disease
* Coronary intervention within 6 months
* Myocardial infarction within 6 months
* Claudication
* Orthostatic syncope within 6 months
* Secondary hypertension (except CKD)
* Significant valvular heart disease
* Clinically significant biochemical abnormalities (electrolytes, haemoglobin, hepatic function, thyroid)
* Second and third degree AV block
* Macroscopic haematuria
* Renal artery anatomy not suitable for renal artery ablation (Stenosis, diameter \< 4 mm, length \< 2 cm or severe calcifications)
* Moderate/severe obstructive sleep apnoea (AHI \> 15) if CPAP treatment has not been attempted

Primary outcomes:
measure: Change from baseline in daytime systolic blood pressure (24-hour ambulatory blood pressure measurement)
timeFrame: 6 months
Secondary outcomes:
measure: Change from baseline in blood pressure (clinic and 24-hour ambulatory blood pressure measurement)
timeFrame: 3 and 6 months
measure: Change from baseline in central blood pressure, augmentation index and pulse wave velocity
timeFrame: 6 months
measure: Change from baseline in cold pressor response
timeFrame: 6 months
measure: Change from baseline in intensity of medical antihypertensive therapy
timeFrame: 1, 3 and 6 months
measure: Blood pressure (clinic measurement)
timeFrame: 1, 3 and 6 months
measure: Renal function (eGFR and electrolytes)
timeFrame: 1, 3 and 6 months
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital, Skejby
Study officials:
affiliation: Skejby Hospital, Dept. of Cardiology
name: Henrik Vase, MD, PhD
role: STUDY_CHAIR
References: