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

Aarhus University Hospital Skejby

Status: Completed

Conditions: Hypertension

Treatments: Procedure: Renal artery ablation; Procedure: Renal angiography

Study type: Interventional

Funder types: Other

Identifiers

NCT01459900

M-20110071

Details and patient eligibility

About

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.

Enrollment: 69 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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69 participants in 2 patient groups

Renal artery ablation

Active Comparator group

Description:

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.

Treatment:

Procedure: Renal artery ablation

Sham

Sham Comparator group

Description:

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.

Treatment:

Procedure: Renal angiography