Hypertension, Resistant to Conventional TherapyPhase 2OsloRDNNCT01673516
Effect of Renal Sympathetic Denervation on Resistant Hypertension and Cardiovascular Hemodynamic in Comparison to Intensive Medical Therapy Utilizing Impedance Cardiography
A Phase 2 study testing The SymplicityTM Renal Denervation System and The HOTMAN® System in people with Hypertension, Resistant to Conventional Therapy, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The purpose of this study is to demonstrate that Renal Sympathetic Denervation (RDN) improves the control of blood pressure (BP) in patients with treatment-resistant hypertension, as compared to intensive medical therapy (IMT) using hemodynamic parameters and then applying a predefined algorithm of drug selection… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Resistant to Conventional Therapy
- What is being tested?
- The SymplicityTM Renal Denervation System and The HOTMAN® System
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteNorway
- Study dates
- Aug 2012to Aug 2022
- Phase
- Phase 2
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Average SBP >140mmHg, measured per guidelines
- 24 hour average ABPM daytime SBP >135mm/Hg
- On stable medication regimen of full tolerated doses of 3 or more antihypertensive meds, with one being a diuretic
- No changes for a minimum of 2 weeks prior to screening
- No planned medication changes for 6 months
- Age 18-80 years
Show all 11Show fewer
- At minimum, 3 antihypertensive medications must meet one or more of the following full dose criteria:
- Highest labeled dose according to medication's labeling
- Highest usual dose per clinical guidelines-JNC-7
- Highest tolerated dose
- Highest appropriate dose for the patient per the PI's clinical judgment
Who cannot join
- Hemodynamically or anatomically significant renal artery abnormalities or stenosis >50% or prior renal artery intervention
- eGFR < 45 mL/min/1.73m2 (MDRD formula)
- Albumin/creatinine ratio > 50 mg/mmol
- Type 1 diabetes mellitus
- Known alcohol or drug abuse
- Symptomatic orthostatic hypotension in past year
Show all 11Show fewer
- Stenotic valvular heart disease for which BP reduction would be hazardous
- MI, unstable angina, or CVA in the prior 6 months
- Known primary pulmonary HTN
- Known pheochromocytoma, Cushing's disease, coarctation of the aorta, hyperthyroidism or hyperparathyroidism
- Known primary hyperaldosteronism not adequately treated.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to demonstrate that Renal Sympathetic Denervation (RDN) improves the control of blood pressure (BP) in patients with treatment-resistant hypertension, as compared to intensive medical therapy (IMT) using hemodynamic parameters and then applying a predefined algorithm of drug selection (i.e. integrated hemodynamic management - IHM) during 6 months intensive treatment program (receiving antihypertensive care according to the 2007 ESH Guidelines). Working hypothesis: When it is possible to disrupt the sympatho-renal axis by RDN - BP reduction occurs to a greater extent and more rapidly than applying intensive medical therapy using IHM.
Read the detailed description
Hypertension is the most common cardiovascular disease, affecting approximately 1 billion1 people worldwide. Hypertension is a major public health concern, because of its complications (coronary artery disease, heart failure, renal disease, stroke). Early blood pressure control in hypertensive patients guarantees the best prevention of cardiovascular events on the long term (2007 ESH-ESC Guidelines on the Management of Hypertension; VALUE study). However, in spite of education efforts and antihypertensive drugs, blood pressure control rates remain low. The most common cause of uncontrolled BP is inadequate pharmacological treatment, because the selection of antihypertensive agents is often done independently of the hemodynamic status of the patient (volemic status, peripheral resistance, cardiac inotropy).
The sympatho-renal axis describes the dual role of the kidney as originator of some central nervous system afferent signals and recipient of efferent sympathetic signals. Both the contribution of the kidney to central sympathetic drive and the consequences of sympathetic efferent drive to the kidney contribute to the development and sustenance of hypertension. Poly-pharmacy strategies for the treatment of elevated blood pressure have identified populations of patients with treatment resistant hypertension.
Treatment Resistant Hypertension(TRH) is a blood pressure that remains above goal in spite of the concomitant use of antihypertensive medications from more than 3 drug classes. Patients who require more than 4 drug classes to have their blood pressure controlled are also considered to have resistant hypertension. Preferably, the regimen should include a diuretic and all doses should be optimal2 .The true prevalence of treatment resistant hypertension is unknown. In clinical trials from 20 to 40% of randomized patients did not reach blood pressure targets3. In the National Health and Nutrition Examination Survey in USA (2003-2008), non-pregnant adults with hypertension were classified as resistant if their blood pressure was 140/90 mmHg or higher and if they reported using antihypertensive medications from 3 different drug classes or drugs from 4 antihypertensive drug classes regardless of blood pressure. The prevalence was 12.8% of the drug-treated hypertensive population. Risk factors for treatment-resistant hypertension include older age and obesity .
Treatment-resistant patients are more likely to have albuminuria, reduced renal function, and a history of diabetes mellitus, coronary heart disease, stroke or heart failure. They are at increased risk of cardiovascular complications although the true incidence of death and morbidity remains currently unknown.
In the Spanish Ambulatory Blood Pressure Monitoring Registry5, 8295 of 68045 treated patients (12.2%) had treatment resistant hypertension, defined as an office blood pressure equal to or exceeding 140 mm Hg systolic and/or 90 mm Hg diastolic.
RDN is a novel procedure which has been approved safe and gives a remarkable reduction of BP in treatment-resistant hypertensive patients. The HOTMAN® System is a novel impedance cardiographic device, measuring and calculating hemodynamic parameters. The HOTMAN® System may help the physician to control blood pressure in patients with resistance hypertension.
- Our pilot study(Renal sympathetic denervation in patients with treatment-resistant hypertension after witnessed intake of medication before qualifying ambulatory blood pressure.Fadl Elmula FE, Hoffmann P, Fossum E, Brekke M, Gjønnæss E, Hjørnholm U, Kjær VN, Rostrup M, Kjeldsen SE, Os I, Stenehjem AE, Høieggen A.Hypertension. 2013 Sep;62(3):526-32)has showed that The mean office and ambulatory BPs remained unchanged at 1, 3, and 6 months in the 6 patients, whereas there was no known change in antihypertensive medication. Two patients, however, had a fall in both office and ambulatory BPs. Our findings question whether BP falls in response to RDN in patients with true treatment-resistant hypertension.That is why we intended to do an intrim analysis after inclusion of around 30% of the total number planned to be included in the study.
- Being tested
- The SymplicityTM Renal Denervation System, The HOTMAN® System
- Keywords
- Renal sympathetic denervation, Impedance cardiography
- Medical subject headings
- Hypertension Resistant to Conventional Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The SymplicityTM Renal Denervation SystemProcedure or surgery
For patients who will be randomly assigned to undergo renal denervation (group RDN), the femoral artery will be accessed with the standard endovascular technique and the catheter will be advanced into the renal artery and connected to a radiofrequency generator. As in Simplicity HTN 1 and 2 trials, four-to-six discrete, low-power radiofrequency ablations lasting up to 2 min each and of 8 watts or less to obtain up to four-six ablations separated both longitudinally and rotationally within each renal artery. During ablation, the catheter system monitored tip temperature and impedance, altering radiofrequency energy delivery in response to a predetermined algorithm.
The HOTMAN® SystemDevice
Impedance Cardiography by HOTMAN system will evaluates non-invasively hemodynamic parameters in patients randomized to "group Co"
| Study group | Role | What they receive |
|---|---|---|
| group Co | Active comparator | group Co receives intensive medical therapy utilizing integrated hemodynamic management calculated by impedance cardiography of "The HOTMAN® System" Receives: Device: The HOTMAN® System |
| group RDN | Active comparator | For patients who will be randomly assigned to undergo renal denervation by "The SymplicityTM Renal Denervation System", the femoral artery will be accessed with the standard endovascular technique and the catheter will be advanced into the renal artery and connected to a radiofrequency generator. As in Symplicity HTN 1 and 2 trials, four-to-six discrete, low-power radiofrequency ablations lasting up to 2 min each and of 8 watts or less to obtain up to four-six ablations separated both longitudinally and rotationally within each renal artery. During ablation, the catheter system monitored tip temperature and impedance, altering radiofrequency energy delivery in response to a predetermined algorithm. Receives: Procedure: The SymplicityTM Renal Denervation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change in office systolic blood pressure(SBP)
is the absolute change in office SBP, after a 6 months follow-up.
Measured: at 6 months
Secondary outcomes (4)
Short and long term safety of RDN as an interventional procedure
Safety of RDN will be assessed at 1, 3, 5 and 10 years by clinical, laboratory and radiology examinations.
Measured: up to10 years
Percentage of normalization of blood pressure(BP) at office, home and ABPM
This will include the percentage of normalization of daytime SBP at office, home and ABPM.
Measured: at 6 months and later
The normalization of hemodynamics.
The normalization of hemodynamics: Cardiac Index (CI), Heart rate, Stroke systemic vascular resistance index (SSVRI), pulse wave velocity(PWV) and central BP.
Measured: at 6 month and later
Cost effectiveness
It will be assessed the Cost effectiveness of Renal denervation as treatment of resistant hypertension compared to control group.
Measured: At 6 month and later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionDec 2013
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Hypertension, Resistant to Conventional TherapyStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aud Høieggen, MD, PhD, Study chair, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01673516
- Sponsor's protocol ID
- 2012/145/REK
- Acronym
- OsloRDN
- Status last verified
- Oct 2015
- First submitted
- 17 Aug 2012
- Last updated
- 30 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Halvorsen LV, Bergland OU, Soraas CL, Larstorp ACK, Hjornholm U, Kjaer VN, Kringen MK, Clasen PE, Haldsrud R, Kjeldsen SE, Rostrup M, Fadl Elmula FEM, Opdal MS, Hoieggen A. Nonadherence by Serum Drug Analyses in Resistant Hypertension: 7-Year Follow-Up of Patients Considered Adherent by Directly Observed Therapy. J Am Heart Assoc. 2022 Sep 20;11(18):e025879. doi: 10.1161/JAHA.121.025879. Epub 2022 Sep 8.
PubMed 36073648Undrum Bergland O, Larstorp ACK, Lund Soraas C, Hoieggen A, Rostrup M, Norheim Kjaer V, Godang K, Sevre K, Fadl Elmula FEM. Changes in sympathetic nervous system activity after renal denervation: results from the randomised Oslo RDN study. Blood Press. 2021 Jun;30(3):154-164. doi: 10.1080/08037051.2020.1868286. Epub 2021 Jan 5.
PubMed 33399016Fadl Elmula FE, Hoffmann P, Larstorp AC, Fossum E, Brekke M, Kjeldsen SE, Gjonnaess E, Hjornholm U, Kjaer VN, Rostrup M, Os I, Stenehjem A, Hoieggen A. Adjusted drug treatment is superior to renal sympathetic denervation in patients with true treatment-resistant hypertension. Hypertension. 2014 May;63(5):991-9. doi: 10.1161/HYPERTENSIONAHA.114.03246. Epub 2014 Mar 3.
PubMed 24591332Kjeldsen SE, Narkiewicz K, Oparil S, Hedner T. Blood pressure lowering effect of renal sympathetic denervation or placebo? - building expectations for Symplicity-HTN 3. Blood Press. 2013 Oct;22(5):279-81. doi: 10.3109/08037051.2013.840445. No abstract available.
PubMed 24059787Fadl Elmula FE, Hoffmann P, Fossum E, Brekke M, Gjonnaess E, Hjornholm U, Kjaer VN, Rostrup M, Kjeldsen SE, Os I, Stenehjem AE, Hoieggen A. Renal sympathetic denervation in patients with treatment-resistant hypertension after witnessed intake of medication before qualifying ambulatory blood pressure. Hypertension. 2013 Sep;62(3):526-32. doi: 10.1161/HYPERTENSIONAHA.113.01452. Epub 2013 Jul 8.
PubMed 23836798
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Renal Sympathetic Denervation on Resistant Hypertension and Cardiovascular Hemodynamic in Comparison to Intensive Medical Therapy Utilizing Impedance Cardiography
- ClinicalTrials.gov ID
- NCT01673516
- Acronym / sponsor ID
- OsloRDN / 2012/145/REK
- Keywords
- Renal sympathetic denervation, Impedance cardiography
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Aug 2022 (estimated)
- First posted
- 28 Aug 2012 (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 study is to demonstrate that Renal Sympathetic Denervation (RDN) improves the control of blood pressure (BP) in patients with treatment-resistant hypertension, as compared to intensive medical therapy (IMT) using hemodynamic parameters and then applying a predefined algorithm of drug selection (i.e. integrated hemodynamic management - IHM) during 6 months intensive treatment program (receiving antihypertensive care according to the 2007 ESH Guidelines). Working hypothesis: When it is possible to disrupt the sympatho-renal axis by RDN - BP reduction occurs to a greater extent and more rapidly than applying intensive medical therapy using IHM.
Detailed description
Hypertension is the most common cardiovascular disease, affecting approximately 1 billion1 people worldwide. Hypertension is a major public health concern, because of its complications (coronary artery disease, heart failure, renal disease, stroke). Early blood pressure control in hypertensive patients guarantees the best prevention of cardiovascular events on the long term (2007 ESH-ESC Guidelines on the Management of Hypertension; VALUE study). However, in spite of education efforts and antihypertensive drugs, blood pressure control rates remain low. The most common cause of uncontrolled BP is inadequate pharmacological treatment, because the selection of antihypertensive agents is often done independently of the hemodynamic status of the patient (volemic status, peripheral resistance, cardiac inotropy).
The sympatho-renal axis describes the dual role of the kidney as originator of some central nervous system afferent signals and recipient of efferent sympathetic signals. Both the contribution of the kidney to central sympathetic drive and the consequences of sympathetic efferent drive to the kidney contribute to the development and sustenance of hypertension. Poly-pharmacy strategies for the treatment of elevated blood pressure have identified populations of patients with treatment resistant hypertension.
Treatment Resistant Hypertension(TRH) is a blood pressure that remains above goal in spite of the concomitant use of antihypertensive medications from more than 3 drug classes. Patients who require more than 4 drug classes to have their blood pressure controlled are also considered to have resistant hypertension. Preferably, the regimen should include a diuretic and all doses should be optimal2 .The true prevalence of treatment resistant hypertension is unknown. In clinical trials from 20 to 40% of randomized patients did not reach blood pressure targets3. In the National Health and Nutrition Examination Survey in USA (2003-2008), non-pregnant adults with hypertension were classified as resistant if their blood pressure was 140/90 mmHg or higher and if they reported using antihypertensive medications from 3 different drug classes or drugs from 4 antihypertensive drug classes regardless of blood pressure. The prevalence was 12.8% of the drug-treated hypertensive population. Risk factors for treatment-resistant hypertension include older age and obesity .
Treatment-resistant patients are more likely to have albuminuria, reduced renal function, and a history of diabetes mellitus, coronary heart disease, stroke or heart failure. They are at increased risk of cardiovascular complications although the true incidence of death and morbidity remains currently unknown.
In the Spanish Ambulatory Blood Pressure Monitoring Registry5, 8295 of 68045 treated patients (12.2%) had treatment resistant hypertension, defined as an office blood pressure equal to or exceeding 140 mm Hg systolic and/or 90 mm Hg diastolic.
RDN is a novel procedure which has been approved safe and gives a remarkable reduction of BP in treatment-resistant hypertensive patients. The HOTMAN® System is a novel impedance cardiographic device, measuring and calculating hemodynamic parameters. The HOTMAN® System may help the physician to control blood pressure in patients with resistance hypertension.
- Our pilot study(Renal sympathetic denervation in patients with treatment-resistant hypertension after witnessed intake of medication before qualifying ambulatory blood pressure.Fadl Elmula FE, Hoffmann P, Fossum E, Brekke M, Gjønnæss E, Hjørnholm U, Kjær VN, Rostrup M, Kjeldsen SE, Os I, Stenehjem AE, Høieggen A.Hypertension. 2013 Sep;62(3):526-32)has showed that The mean office and ambulatory BPs remained unchanged at 1, 3, and 6 months in the 6 patients, whereas there was no known change in antihypertensive medication. Two patients, however, had a fall in both office and ambulatory BPs. Our findings question whether BP falls in response to RDN in patients with true treatment-resistant hypertension.That is why we intended to do an intrim analysis after inclusion of around 30% of the total number planned to be included in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group Co | Active comparator | Device: The HOTMAN® Systemgroup Co receives intensive medical therapy utilizing integrated hemodynamic management calculated by impedance cardiography of "The HOTMAN® System" |
| group RDN | Active comparator | Procedure: The SymplicityTM Renal Denervation SystemFor patients who will be randomly assigned to undergo renal denervation by "The SymplicityTM Renal Denervation System", the femoral artery will be accessed with the standard endovascular technique and the catheter will be advanced into the renal artery and connected to a radiofrequency generator. As in Symplicity HTN 1 and 2 trials, four-to-six discrete, low-power radiofrequency ablations lasting up to 2 min each and of 8 watts or less to obtain up to four-six ablations separated both longitudinally and rotationally within each renal artery. During ablation, the catheter system monitored tip temperature and impedance, altering radiofrequency energy delivery in response to a predetermined algorithm. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Average SBP >140mmHg, measured per guidelines
- 24 hour average ABPM daytime SBP >135mm/Hg
- On stable medication regimen of full tolerated doses of 3 or more antihypertensive meds, with one being a diuretic
- No changes for a minimum of 2 weeks prior to screening
- No planned medication changes for 6 months
Key exclusion criteria (11 listed)
- Hemodynamically or anatomically significant renal artery abnormalities or stenosis >50% or prior renal artery intervention
- eGFR < 45 mL/min/1.73m2 (MDRD formula)
- Albumin/creatinine ratio > 50 mg/mmol
- Type 1 diabetes mellitus
- Known alcohol or drug abuse
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 |
|---|---|---|
| The SymplicityTM Renal Denervation SystemFor patients who will be randomly assigned to undergo renal denervation (group RDN), the femoral artery will be accessed with the standard endovascular technique and the catheter will be advanced into the renal artery and connected to a radiofrequency generator. As in Simplicity HTN 1 and 2 trials, four-to-six discrete, low-power radiofrequency ablations lasting up to 2 min each and of 8 watts or less to obtain up to four-six ablations separated both longitudinally and rotationally within each renal artery. During ablation, the catheter system monitored tip temperature and impedance, altering radiofrequency energy delivery in response to a predetermined algorithm. | Procedure or surgery | group RDN |
| The HOTMAN® SystemImpedance Cardiography by HOTMAN system will evaluates non-invasively hemodynamic parameters in patients randomized to "group Co" | Device | group Co |
Primary outcome
Absolute change in office systolic blood pressure(SBP)
Time frame: at 6 months
is the absolute change in office SBP, after a 6 months follow-up.
4 secondary outcomes
Short and long term safety of RDN as an interventional procedure
Time frame: up to10 years
Percentage of normalization of blood pressure(BP) at office, home and ABPM
Time frame: at 6 months and later
The normalization of hemodynamics.
Time frame: at 6 month and later
Cost effectiveness
Time frame: At 6 month and later
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2015.
- Derived from this study: PubMed 36073648Halvorsen LV, Bergland OU, Soraas CL, Larstorp ACK, Hjornholm U, Kjaer VN, Kringen MK, Clasen PE, Haldsrud R, Kjeldsen SE, Rostrup M, Fadl Elmula FEM, Opdal MS, Hoieggen A. Nonadherence by Serum Drug Analyses in Resistant Hypertension: 7-Year Follow-Up of Patients Considered Adherent by Directly Observed Therapy. J Am Heart Assoc. 2022 Sep 20;11(18):e025879. doi: 10.1161/JAHA.121.025879. Epub 2022 Sep 8.
- Derived from this study: PubMed 33399016Undrum Bergland O, Larstorp ACK, Lund Soraas C, Hoieggen A, Rostrup M, Norheim Kjaer V, Godang K, Sevre K, Fadl Elmula FEM. Changes in sympathetic nervous system activity after renal denervation: results from the randomised Oslo RDN study. Blood Press. 2021 Jun;30(3):154-164. doi: 10.1080/08037051.2020.1868286. Epub 2021 Jan 5.
- Derived from this study: PubMed 24591332Fadl Elmula FE, Hoffmann P, Larstorp AC, Fossum E, Brekke M, Kjeldsen SE, Gjonnaess E, Hjornholm U, Kjaer VN, Rostrup M, Os I, Stenehjem A, Hoieggen A. Adjusted drug treatment is superior to renal sympathetic denervation in patients with true treatment-resistant hypertension. Hypertension. 2014 May;63(5):991-9. doi: 10.1161/HYPERTENSIONAHA.114.03246. Epub 2014 Mar 3.
- Derived from this study: PubMed 24059787Kjeldsen SE, Narkiewicz K, Oparil S, Hedner T. Blood pressure lowering effect of renal sympathetic denervation or placebo? - building expectations for Symplicity-HTN 3. Blood Press. 2013 Oct;22(5):279-81. doi: 10.3109/08037051.2013.840445. No abstract available.
- Derived from this study: PubMed 23836798Fadl Elmula FE, Hoffmann P, Fossum E, Brekke M, Gjonnaess E, Hjornholm U, Kjaer VN, Rostrup M, Kjeldsen SE, Os I, Stenehjem AE, Hoieggen A. Renal sympathetic denervation in patients with treatment-resistant hypertension after witnessed intake of medication before qualifying ambulatory blood pressure. Hypertension. 2013 Sep;62(3):526-32. doi: 10.1161/HYPERTENSIONAHA.113.01452. Epub 2013 Jul 8.
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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.
Aud Høieggen, MD, PhD study chair
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing The SymplicityTM Renal Denervation System and The HOTMAN® System in people with Hypertension, Resistant to Conventional Therapy, run by Oslo University Hospital at 1 site in Norway.
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 11 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 30 Oct 2015. 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 Norway. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Absolute change in office systolic blood pressure(SBP) (time frame: at 6 months). 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 NCT01673516, which also lists 5 linked publications.
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 30 Oct 2015.