Renal Denervation in Treatment Resistant Hypertension

Renal Denervation in Treatment Resistant Hypertension, a Double-blind Randomized Controlled Trial

The purpose of this double-blind, randomized and sham controlled study is to investigate the blood pressure lowering effect of renal denervation by catheter based ablation in the renal arteries in patients with milder forms of treatment resistant hypertension. The effect on blood pressure will be evaluated by 24-hour ambulatory blood pressure measurements at baseline and after 3 and 6 months of follow up. Secondary endpoint evaluation comprises hemodynamic assessment by applanation tonometry and the cold pressor response.

Inclusion Criteria:

• Systolic daytime (24 hour-ambulatory blood pressure measurement) > 135 mmHg and < 145 mmHg.
• Stable (for at least 1 month and with no planned changes for the next 6 months) antihypertensive therapy with at least 3 antihypertensive drugs, including a diuretic.
• Documented adherence to present antihypertensive therapy

Exclusion Criteria:

• Pregnancy
• Non compliance
• Heart failure (NYHA Class III-IV)
• LV ejection fraction < 50 %
• Renal insufficiency (eGFR<30 ml/min)
• Unstable coronary heart disease
• Coronary intervention within 6 months
• Myocardial infarction within 6 months
• Claudication
• Orthostatic syncope within 6 months
• Secondary hypertension (except CKD)
• Significant valvular heart disease
• Clinically significant biochemical abnormalities (electrolytes, haemoglobin, hepatic function, thyroid)
• Second and third degree AV block
• Macroscopic haematuria
• Renal artery anatomy not suitable for renal artery ablation (Stenosis, diameter < 4 mm, length < 2 cm or severe calcifications)
• Moderate/severe obstructive sleep apnoea (AHI > 15) if CPAP treatment has not been attempted