Renal Denervation in Treatment Resistant Hypertension

Phase 3

Terminated

• Conditions: Hypertension
• Interventions: Procedure: Ablation of the renal arteries; Procedure: Renal angiography

• Registration Number: NCT01762488
• Lead Sponsor: Henrik Vase

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-04
• Study First Submitted QC: 2013-01-04
• Study First Posted: 2013-01-07
• Primary Completion: 2016-02
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-20
• Last Update Posted: 2016-05-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Renal denervation by ablation of the renal arteries	Ablation of the renal arteries	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.
Control	Renal angiography	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.

Primary Outcome Measures

Name	Time	Method
Change from baseline in daytime systolic blood pressure (24-hour ambulatory blood pressure measurement)	6 months

Secondary Outcome Measures

Name	Time	Method
Change from baseline in blood pressure (clinic and 24-hour ambulatory blood pressure measurement)	3 and 6 months
Change from baseline in central blood pressure, augmentation index and pulse wave velocity	6 months
Change from baseline in cold pressor response	6 months
Change from baseline in intensity of medical antihypertensive therapy	1, 3 and 6 months
Blood pressure (clinic measurement)	1, 3 and 6 months
Renal function (eGFR and electrolytes)	1, 3 and 6 months

Trial Locations

Locations (1)

Aarhus University Hospital, Skejby; 🇩🇰 Aarhus, Denmark