Hypertension
Conditions
Keywords
Treatment Resistant Hypertension
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 blood pressure in patients with treatment resistant hypertension. The blood pressure lowering effect will be evaluated by 24 hours ambulatory blood pressure measurement at baseline and after 1, 3 and 6 months of follow up. Secondary end point evaluation concerns hemodynamic measures using echocardiography, applanation tonometry and forearm plethysmography.
Interventions
PROCEDURERenal artery ablation
Catheter based renal denervation by applying low power radiofrequency to the renal artery using the Ardian Medtronic Simplicity Catheter, introduced by femoral artery access.
PROCEDURERenal angiography
Renal angiography by femoral access.
Sponsors
Aarhus University Hospital
Regionshospitalet Silkeborg
Randers Regional Hospital
Regional Hospital Holstebro
Central Jutland Regional Hospital
Aarhus University Hospital Skejby
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| daytime systolic blood pressure assessed by 24 hours ambulatory BP measurement | 3 months follow up | Changes in mean daytime systolic BP after 3 months is compared between groups. Also the proportion of responders versus nonresponders after 3 months is compared between groups, responders being defined as A) a minimum decrease in daytime systolic BP of 10 mmHg analysis together with and unchanged/increased number of antihypertensive drugs, or B) a decrease in daytime systolic BP of 0-10 mmHg together with a reduced number of antihypertensive drugs. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ambulatory 24 hours BP measurements | 1, 3 and 6 months | Systolic, diastolic and mean Blood Pressures at different time points. Daytime and night time BP, dipping status, morning BP surge and BP variation. |
| Echocardiography | 6 months | Coronary flow reserve (LAD), Diastolic and Systolic ventricular function. LV hypertrophy. |
| Biomarkers | 1 months | Biomarkers concerning renal sodium excretion |
| Applanation tonometry | 6 months | Pulse wave velocity, augmentation index, central BP estimates |
| forearm plethysmography | 6 months | Forearm minimum vascular resistance |
Countries
Denmark
Outcome results
None listed