HypertensionReSETNCT01459900
Renal Sympathectomy in Treatment Resistant Essential Hypertension, a Sham Controlled Randomized Trial
A study testing Renal artery ablation and Renal angiography in people with Hypertension, run by Aarhus University Hospital Skejby at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Renal artery ablation and Renal angiography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2011to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Pregnancy
- Non compliance
- Heart Failure (NYHA 3-4)
- LV ejection fraction < 50 %
- Renal insufficiency (eGFR<30)
- Unstable coronary heart disease
Show all 18Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Hypertension
- Being tested
- Renal artery ablation, Renal angiography
- Keywords
- Treatment Resistant Hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal artery ablationProcedure or surgery
Catheter based renal denervation by applying low power radiofrequency to the renal artery using the Ardian Medtronic Simplicity Catheter, introduced by femoral artery access.
Renal angiographyProcedure or surgery
Renal angiography by femoral access.
| Study group | Role | What they receive |
|---|---|---|
| Renal artery ablation | Active comparator | 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. Receives: Procedure: Renal artery ablation |
| Sham | Sham comparator | 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. Receives: Procedure: Renal angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months follow up
Secondary outcomes (5)
ambulatory 24 hours BP measurements
Systolic, diastolic and mean Blood Pressures at different time points. Daytime and night time BP, dipping status, morning BP surge and BP variation.
Measured: 1, 3 and 6 months
Echocardiography
Coronary flow reserve (LAD), Diastolic and Systolic ventricular function. LV hypertrophy.
Measured: 6 months
Biomarkers
Biomarkers concerning renal sodium excretion
Measured: 1 months
Applanation tonometry
Pulse wave velocity, augmentation index, central BP estimates
Measured: 6 months
forearm plethysmography
Forearm minimum vascular resistance
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2011 (estimated)
- Study startSep 2011
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital Skejby
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Regionshospitalet Silkeborg, Randers Regional Hospital, Regional Hospital Holstebro, Central Jutland Regional Hospital
- Responsible party
- Principal investigator, Ole Norling Mathiassen, Aarhus University Hospital Skejby
- Investigators
- Ole N Mathiassen, MD, PhD, Principal investigator, Aarhus University Hospital, Dep. Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01459900
- Sponsor's protocol ID
- M-20110071
- Acronym
- ReSET
- Status last verified
- Sep 2016
- First submitted
- 24 Oct 2011
- Last updated
- 20 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 28830251
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Sympathectomy in Treatment Resistant Essential Hypertension, a Sham Controlled Randomized Trial
- ClinicalTrials.gov ID
- NCT01459900
- Acronym / sponsor ID
- ReSET / M-20110071
- Conditions
- Hypertension
- Keywords
- Treatment Resistant Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Aarhus University Hospital SkejbyUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Regionshospitalet Silkeborg, Randers Regional Hospital, Regional Hospital Holstebro, Central Jutland Regional Hospital
- Study start
- Sep 2011
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 26 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Renal artery ablation | Active comparator | Procedure: Renal artery ablationBy 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 comparator | Procedure: Renal angiographyBy 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. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (18 listed)
- Pregnancy
- Non compliance
- Heart Failure (NYHA 3-4)
- LV ejection fraction < 50 %
- Renal insufficiency (eGFR<30)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Renal artery ablationCatheter based renal denervation by applying low power radiofrequency to the renal artery using the Ardian Medtronic Simplicity Catheter, introduced by femoral artery access. | Procedure or surgery | Renal artery ablation |
| Renal angiographyRenal angiography by femoral access. | Procedure or surgery | Sham |
Primary outcome
daytime systolic blood pressure assessed by 24 hours ambulatory BP measurement
Time frame: 3 months follow up
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.
5 secondary outcomes
ambulatory 24 hours BP measurements
Time frame: 1, 3 and 6 months
Echocardiography
Time frame: 6 months
Biomarkers
Time frame: 1 months
Applanation tonometry
Time frame: 6 months
forearm plethysmography
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2016.
- Derived from this study: PubMed 28830251Peters 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ole N Mathiassen, MD, PhD principal investigator
Aarhus University Hospital, Dep. Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Renal artery ablation and Renal angiography in people with Hypertension, run by Aarhus University Hospital Skejby at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
daytime systolic blood pressure assessed by 24 hours ambulatory BP measurement (time frame: 3 months follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01459900, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2016.