Renal Sympathectomy in Treatment Resistant Essential Hypertension, a Sham Controlled Randomized Trial
- Conditions
- Hypertension
- Interventions
- Procedure: Renal angiographyProcedure: Renal artery ablation
- Registration Number
- NCT01459900
- Lead Sponsor
- Aarhus University Hospital Skejby
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 69
- 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.
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sham Renal angiography By femoral access, coronary and renal angiography are performed. The patient will be sedated. In case of vessel anatomy allowing renal ablation, the patient will be randomized in the card. lab. In case of randomization to sham procedure, no renal artery ablation are performed. Renal artery ablation Renal artery ablation By femoral access, coronary and renal angiography are performed. The patient will be sedated. In case of vessel anatomy allowing renal ablation, the patient will be randomized in the card. lab. In case of randomization to active treatment, renal artery ablation will be carried out straight away.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Biomarkers 1 months Biomarkers concerning renal sodium excretion
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.
Applanation tonometry 6 months Pulse wave velocity, augmentation index, central BP estimates
forearm plethysmography 6 months Forearm minimum vascular resistance
Trial Locations
- Locations (1)
Skejby Hospital
🇩🇰Aarhus, Aarhus N, Denmark