Renal Sympathectomy in Treatment Resistant Essential Hypertension, a Sham Controlled Randomized Trial (ReSET)

This study is currently recruiting participants.
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

October 24, 2011
July 29, 2013
September 2011
September 2014   (final data collection date for primary outcome measure)
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.
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 recuced number of antihypertensive drugs.
Complete list of historical versions of study NCT01459900 on ClinicalTrials.gov Archive Site
  • 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
  • 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 hyperthrophy.
  • 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
Not Provided
Not Provided
 
Renal Sympathectomy in Treatment Resistant Essential Hypertension, a Sham Controlled Randomized Trial
Renal Sympathectomy in Treatment Resistant Essential Hypertension, a Sham Controlled Randomized Trial

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Hypertension
  • 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.
  • Procedure: Renal angiography
    Renal angiography by femoral access.
  • 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.
    Intervention: Procedure: Renal artery ablation
  • 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.
    Intervention: Procedure: Renal angiography
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
70
April 2015
September 2014   (final data collection date for primary outcome measure)

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)
Both
30 Years to 70 Years
No
Contact: Ole N Mathiassen, MD, PhD +45 89495566 onm@farm.au.dk
Contact: Anne Kaltoft, MD, PhD +45 89495566 annekaltoft@dadlnet.dk
Denmark
 
NCT01459900
M-20110071
Yes
Ole Norling Mathiassen, Aarhus University Hospital Skejby
Aarhus University Hospital Skejby
  • Aarhus University Hospital
  • Regionshospitalet Silkeborg
  • Randers Regional Hospital
  • Regional Hospital Holstebro
  • Viborg Hospital
Not Provided
Aarhus University Hospital Skejby
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP