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Renal Denervation in Treatment Resistant Hypertension (ReSET-2)

This study is currently recruiting participants.
Verified January 2013 by Skejby Hospital
Sponsor:
Collaborators:
Aarhus University Hospital
Regionshospitalet Silkeborg
Randers Region Hospital
Viborg Hospital
Regional Hospital Holstebro
Information provided by (Responsible Party):
Henrik Vase, Skejby Hospital
ClinicalTrials.gov Identifier:
NCT01762488
First received: January 4, 2013
Last updated: January 5, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Hypertension
 Procedure: Ablation of the renal arteries
Procedure: Renal angiography
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Renal Denervation in Treatment Resistant Hypertension, a Double-blind Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Skejby Hospital:

Primary Outcome Measures:
  • Change from baseline in daytime systolic blood pressure (24-hour ambulatory blood pressure measurement) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in blood pressure (clinic and 24-hour ambulatory blood pressure measurement) [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
  • Change from baseline in central blood pressure, augmentation index and pulse wave velocity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change from baseline in cold pressor response [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change from baseline in intensity of medical antihypertensive therapy [ Time Frame: 1, 3 and 6 months ] [ Designated as safety issue: No ]
  • Blood pressure (clinic measurement) [ Time Frame: 1, 3 and 6 months ] [ Designated as safety issue: Yes ]
  • Renal function (eGFR and electrolytes) [ Time Frame: 1, 3 and 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 70
Study Start Date: January 2013
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01762488

Contacts
Contact: Henrik Vase, MD, PhD henvas@rm.dk
Contact: Ole Mathiassen, MD, PhD onm@farm.au.dk

Locations
Denmark
Aarhus University Hospital, Skejby Recruiting
Aarhus, Denmark, 8200
Contact: Henrik Vase, MD, PhD         henvas@rm.dk    
Principal Investigator: Henrik Vase, MD, PhD            
Sponsors and Collaborators
Henrik Vase
Aarhus University Hospital
Regionshospitalet Silkeborg
Randers Region Hospital
Viborg Hospital
Regional Hospital Holstebro
Investigators
Study Chair: Henrik Vase, MD, PhD Skejby Hospital, Dept. of Cardiology
  More Information

No publications provided

Responsible Party: Henrik Vase, MD, PhD, Skejby Hospital
ClinicalTrials.gov Identifier: NCT01762488     History of Changes
Other Study ID Numbers: 35218
Study First Received: January 4, 2013
Last Updated: January 5, 2013
Health Authority: Denmark: Ethics Committee
Denmark: Danish Dataprotection Agency

Keywords provided by Skejby Hospital:
Treatment Resistant Hypertension
Renal Denervation

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013