Renal Sympathectomy in Treatment Resistant Essential Hypertension, a Sham Controlled Randomized Trial
ReSET
1 other identifier
interventional
69
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable hypertension
Started Sep 2011
Typical duration for not_applicable hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 24, 2011
CompletedFirst Posted
Study publicly available on registry
October 26, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedSeptember 20, 2016
September 1, 2016
3.4 years
October 24, 2011
September 19, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
daytime systolic blood pressure assessed by 24 hours ambulatory BP measurement
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.
3 months follow up
Secondary Outcomes (5)
ambulatory 24 hours BP measurements
1, 3 and 6 months
Echocardiography
6 months
Biomarkers
1 months
Applanation tonometry
6 months
forearm plethysmography
6 months
Study Arms (2)
Renal artery ablation
ACTIVE COMPARATORBy 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.
Sham
SHAM COMPARATORBy 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.
Interventions
Catheter based renal denervation by applying low power radiofrequency to the renal artery using the Ardian Medtronic Simplicity Catheter, introduced by femoral artery access.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aarhus University Hospital Skejbylead
- Aarhus University Hospitalcollaborator
- Regionshospitalet Silkeborgcollaborator
- Randers Regional Hospitalcollaborator
- Regional Hospital Holstebrocollaborator
- Central Jutland Regional Hospitalcollaborator
Study Sites (1)
Skejby Hospital
Aarhus, Aarhus N, 8200, Denmark
Related Publications (1)
Peters CD, Mathiassen ON, Vase H, Bech Norgaard J, Christensen KL, Schroeder AP, Rickers HJVH, Opstrup UK, Poulsen PL, Langfeldt S, Andersen G, Hansen KW, Botker HE, Engholm M, Bertelsen JB, Pedersen EB, Kaltoft A, Buus NH. The effect of renal denervation on arterial stiffness, central blood pressure and heart rate variability in treatment resistant essential hypertension: a substudy of a randomized sham-controlled double-blinded trial (the ReSET trial). Blood Press. 2017 Dec;26(6):366-380. doi: 10.1080/08037051.2017.1368368. Epub 2017 Aug 23.
PMID: 28830251DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ole N Mathiassen, MD, PhD
Aarhus University Hospital, Dep. Cardiology
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.med
Study Record Dates
First Submitted
October 24, 2011
First Posted
October 26, 2011
Study Start
September 1, 2011
Primary Completion
February 1, 2015
Study Completion
February 1, 2015
Last Updated
September 20, 2016
Record last verified: 2016-09