Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
8 participants
INTERVENTIONAL
2013-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Renal denervation by ablation of the renal arteries
By femoral access, renal angiography is performed. The patient will be sedated. In case of acceptable renal artery anatomy allowing renal ablation, the patient will be randomized in the cath. lab. If randomized to active treatment, renal artery ablation will be carried out straight away.
Ablation of the renal arteries
Catheter-based renal denervation by applying low power radiofrequency to the renal artery using the EnligHTN Catheter, introduced by femoral artery access.
Control
By femoral access, renal angiography is performed. The patient will be sedated. In case of acceptable renal artery anatomy allowing renal ablation, the patient will be randomized in the cath. lab. If randomized to sham treatment, the procedure stops.
Renal angiography
Renal angiography by femoral access
Interventions
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Ablation of the renal arteries
Catheter-based renal denervation by applying low power radiofrequency to the renal artery using the EnligHTN Catheter, introduced by femoral artery access.
Renal angiography
Renal angiography by femoral access
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
30 Years
70 Years
ALL
No
Sponsors
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Aarhus University Hospital
OTHER
Regionshospitalet Silkeborg
OTHER
Randers Regional Hospital
OTHER
Central Jutland Regional Hospital
OTHER
Regional Hospital Holstebro
OTHER
Henrik Vase
OTHER
Responsible Party
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Henrik Vase
MD, PhD
Principal Investigators
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Henrik Vase, MD, PhD
Role: STUDY_CHAIR
Skejby Hospital, Dept. of Cardiology
Locations
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Aarhus University Hospital, Skejby
Aarhus, , Denmark
Countries
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Other Identifiers
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35218
Identifier Type: -
Identifier Source: org_study_id
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