Renal Denervation in Treatment Resistant Hypertension (ReSET-2)

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.

Study Overview

• Status: Terminated
• Conditions: Hypertension
• Intervention / Treatment: Procedure: Ablation of the renal arteries; Procedure: Renal angiography

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 3

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8200
    • Aarhus University Hospital, Skejby

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Renal denervation by 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.	Procedure: Ablation of the renal arteries; Catheter-based renal denervation by applying low power radiofrequency to the renal artery using the EnligHTN Catheter, introduced by femoral artery access.
SHAM_COMPARATOR: Control; 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.	Procedure: Renal angiography; Renal angiography by femoral access

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in daytime systolic blood pressure (24-hour ambulatory blood pressure measurement)	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Henrik Vase
• Collaborators: Aarhus University Hospital; Regional Hospital Holstebro; Regionshospitalet Silkeborg; Randers Regional Hospital; Central Jutland Regional Hospital
• Investigators: Study Chair: Henrik Vase, MD, PhD, Skejby Hospital, Dept. of Cardiology

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (ACTUAL): February 1, 2016

Study Registration Dates

• First Submitted: January 4, 2013
• First Submitted That Met QC Criteria: January 4, 2013
• First Posted (ESTIMATE): January 7, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): May 23, 2016
• Last Update Submitted That Met QC Criteria: May 20, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Renal Denervation; Treatment Resistant Hypertension
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 35218