Renal Denervation in Treatment Resistant Hypertension (ReSET-2)

Henrik Vase

Status and phase: Terminated; Phase 3

Conditions: Hypertension

Treatments: Procedure: Ablation of the renal arteries; Procedure: Renal angiography

Study type: Interventional

Funder types: Other

Identifiers

NCT01762488

35218

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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8 participants in 2 patient groups

Renal denervation by ablation of the renal arteries

Active Comparator group

Description:

By femoral access, renal angiography is performed. The patient will be sedated. In case of acceptable renal artery anatomy allowing renal ablation, the patient will be randomized in the cath. lab. If randomized to active treatment, renal artery ablation will be carried out straight away.

Treatment:

Procedure: Ablation of the renal arteries

Control

Sham Comparator group

Description:

By femoral access, renal angiography is performed. The patient will be sedated. In case of acceptable renal artery anatomy allowing renal ablation, the patient will be randomized in the cath. lab. If randomized to sham treatment, the procedure stops.

Treatment:

Procedure: Renal angiography