Status:
COMPLETED
Renal Sympathectomy in Treatment Resistant Essential Hypertension, a Sham Controlled Randomized Trial
Lead Sponsor:
Aarhus University Hospital Skejby
Collaborating Sponsors:
Aarhus University Hospital
Regionshospitalet Silkeborg
Conditions:
Hypertension
Eligibility:
All Genders
30-70 years
Phase:
NA
Brief Summary
The purpose of this double blind, randomized and sham controlled study is to determine whether renal denervation in terms of catheter based ablation in the renal arteries is effective in lowering bloo...
Eligibility Criteria
Inclusion
- Systolic daytime ambulatory BP at least 145 mmHg and compliance to a minimum of 3 antihypertensive drugs, including a diuretic, or in case of diuretic intolerance at least 3 nondiuretic antihypertensive drugs.
Exclusion
- Pregnancy
- Non compliance
- Heart Failure (NYHA 3-4)
- LV ejection fraction \< 50 %
- Renal insufficiency (eGFR\<30)
- Unstable coronary heart disease
- Coronary intervention within 6 months
- Myocardial infarction within 6 months
- Claudication
- Orthostatic syncope within 6 months
- Secondary Hypertension
- Permanent atrial fibrillation
- Significant Heart Valve Disease
- Clinically Significant abnormal electrolytes, haemoglobin, Liver enzymes, TSH
- Second and third degree heart block
- Macroscopic haematuria
- Proximal significant coronary stenosis
- Renal artery anatomy not suitable for renal artery ablation (Stenosis, small diameter \< 4 mm, length \< 2 cm, multiple renal arteries, severe calcifications)
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT01459900
Start Date
September 1 2011
End Date
February 1 2015
Last Update
September 20 2016
Active Locations (1)
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1
Skejby Hospital
Aarhus, Aarhus N, Denmark, 8200