Renal Sympathectomy in Treatment Resistant Essential Hypertension, a Sham Controlled Randomized Trial

Aarhus University Hospital Skejby69 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Hypertension

Interventions

Renal artery ablation

Eligibility

Sex: ALLMin age: 30 YearsMax age: 70 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

daytime systolic blood pressure assessed by 24 hours ambulatory BP measurement

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.

Time frame: 3 months follow up

Secondary Outcomes

ambulatory 24 hours BP measurements

Systolic, diastolic and mean Blood Pressures at different time points. Daytime and night time BP, dipping status, morning BP surge and BP variation.

Time frame: 1, 3 and 6 months

Echocardiography

Coronary flow reserve (LAD), Diastolic and Systolic ventricular function. LV hypertrophy.

Time frame: 6 months

Biomarkers

Biomarkers concerning renal sodium excretion

Time frame: 1 months

Applanation tonometry

Pulse wave velocity, augmentation index, central BP estimates

Time frame: 6 months

forearm plethysmography

Forearm minimum vascular resistance

Time frame: 6 months

Renal Sympathectomy in Treatment Resistant Essential Hypertension, a Sham Controlled Randomized Trial

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes