Trial record 1 of 1 for:    NCT01459900
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Renal Sympathectomy in Treatment Resistant Essential Hypertension, a Sham Controlled Randomized Trial (ReSET)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Aarhus University Hospital Skejby
Sponsor:
Collaborators:
Aarhus University Hospital
Regionshospitalet Silkeborg
Randers Regional Hospital
Regional Hospital Holstebro
Viborg Hospital
Information provided by (Responsible Party):
Ole Norling Mathiassen, Aarhus University Hospital Skejby
ClinicalTrials.gov Identifier:
NCT01459900
First received: October 24, 2011
Last updated: July 29, 2013
Last verified: July 2013
  Purpose

The purpose of this double blind, randomized and sham controlled study is to determine whether renal denervation in terms of catheter based ablation in the renal arteries is effective in lowering blood pressure in patients with treatment resistant hypertension. The blood pressure lowering effect will be evaluated by 24 hours ambulatory blood pressure measurement at baseline and after 1, 3 and 6 months of follow up. Secondary end point evaluation concerns hemodynamic measures using echocardiography, applanation tonometry and forearm plethysmography.


Condition Intervention
Hypertension
Procedure: Renal artery ablation
Procedure: Renal angiography

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Renal Sympathectomy in Treatment Resistant Essential Hypertension, a Sham Controlled Randomized Trial

Resource links provided by NLM:


Further study details as provided by Aarhus University Hospital Skejby:

Primary Outcome Measures:
  • daytime systolic blood pressure assessed by 24 hours ambulatory BP measurement [ Time Frame: 3 months follow up ] [ Designated as safety issue: No ]
    Changes in mean daytime systolic BP after 3 months is compared between groups. Also the proportion of responders versus nonresponders after 3 months is compared between groups, responders being defined as A) a minimum decrease in daytime systolic BP of 10 mmHg analysis together with and unchanged/increased number of antihypertensive drugs, or B) a decrease in daytime systolic BP of 0-10 mmHg together with a reduced number of antihypertensive drugs.


Secondary Outcome Measures:
  • ambulatory 24 hours BP measurements [ Time Frame: 1, 3 and 6 months ] [ Designated as safety issue: No ]
    Systolic, diastolic and mean Blood Pressures at different time points. Daytime and night time BP, dipping status, morning BP surge and BP variation.

  • Echocardiography [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Coronary flow reserve (LAD), Diastolic and Systolic ventricular function. LV hypertrophy.

  • Biomarkers [ Time Frame: 1 months ] [ Designated as safety issue: No ]
    Biomarkers concerning renal sodium excretion

  • Applanation tonometry [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Pulse wave velocity, augmentation index, central BP estimates

  • forearm plethysmography [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Forearm minimum vascular resistance


Estimated Enrollment: 70
Study Start Date: September 2011
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Renal artery ablation
By femoral access, coronary and renal angiography are performed. The patient will be sedated. In case of vessel anatomy allowing renal ablation, the patient will be randomized in the card. lab. In case of randomization to active treatment, renal artery ablation will be carried out straight away.
Procedure: Renal artery ablation
Catheter based renal denervation by applying low power radiofrequency to the renal artery using the Ardian Medtronic Simplicity Catheter, introduced by femoral artery access.
Sham Comparator: Sham
By femoral access, coronary and renal angiography are performed. The patient will be sedated. In case of vessel anatomy allowing renal ablation, the patient will be randomized in the card. lab. In case of randomization to sham procedure, no renal artery ablation are performed.
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 ambulatory BP at least 145 mmHg and compliance to a minimum of 3 antihypertensive drugs, including a diuretic, or in case of diuretic intolerance at least 3 nondiuretic antihypertensive drugs.

Exclusion Criteria:

  • Pregnancy
  • Non compliance
  • Heart Failure (NYHA 3-4)
  • LV ejection fraction < 50 %
  • Renal insufficiency (eGFR<30)
  • Unstable coronary heart disease
  • Coronary intervention within 6 months
  • Myocardial infarction within 6 months
  • Claudication
  • Orthostatic syncope within 6 months
  • Secondary Hypertension
  • Permanent atrial fibrillation
  • Significant Heart Valve Disease
  • Clinically Significant abnormal electrolytes, haemoglobin, Liver enzymes, TSH
  • Second and third degree heart block
  • Macroscopic haematuria
  • Proximal significant coronary stenosis
  • Renal artery anatomy not suitable for renal artery ablation (Stenosis, small diameter < 4 mm, length < 2 cm, multiple renal arteries, severe calcifications)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01459900

Contacts
Contact: Ole N Mathiassen, MD, PhD +45 89495566 onm@farm.au.dk
Contact: Anne Kaltoft, MD, PhD +45 89495566 annekaltoft@dadlnet.dk

Locations
Denmark
Skejby Hospital Recruiting
Aarhus, Aarhus N, Denmark, 8200
Contact: Ole N Mathiassen, MD, PhD    +45 89495566    onm@farm.au.dk   
Principal Investigator: Ole N Mathiassen, MD, PhD         
Sponsors and Collaborators
Aarhus University Hospital Skejby
Aarhus University Hospital
Regionshospitalet Silkeborg
Randers Regional Hospital
Regional Hospital Holstebro
Viborg Hospital
  More Information

No publications provided

Responsible Party: Ole Norling Mathiassen, Dr.med, Aarhus University Hospital Skejby
ClinicalTrials.gov Identifier: NCT01459900     History of Changes
Other Study ID Numbers: M-20110071
Study First Received: October 24, 2011
Last Updated: July 29, 2013
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Ethics Committee

Keywords provided by Aarhus University Hospital Skejby:
Treatment Resistant Hypertension

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 01, 2014