HypertensionPhase 2NCT02608632
HFS-guided Renal Ablation for Improving Outcome of Renal Denervation Procedure
A Phase 2 study testing Renal denervation guided by HFS and Renal denervation as standard procedure in people with Hypertension, run by Meshalkin Research Institute of Pathology of Circulation at 3 sites in Russia.
Trial summary
To increase the number of responders using HFS-guided renal artery denervation (RDN) in patients with resistant and moderate resistant hypertension Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Renal denervation guided by HFS and Renal denervation as standard procedure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 3 sitesRussia
- Study dates
- Feb 2013to Feb 2016
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Office-based systolic blood pressure of ≥140/90 mm Hg and <160/100 mm Hg (moderate resistant hypertension) or ≥160/100 mm Hg (severe resistant hypertension), despite treatment with 3 antihypertensive drugs (including a diuretic).
- A glomerular filtration rate ≥45 mL/min/1⋅73 m2, with modification of diet using a renal disease formula.
Who cannot join
- Secondary causes of hypertension
- Severe renal artery stenosis or dual renal arteries
- Congestive heart failure
- Left ventricular ejection fraction <35%
- Previous renal artery stenting or angioplasty
- Type 1 diabetes mellitus
Trial locations and contacts
3 sites in 1 country.
Russia3 sites
Federal Center of Cardiovascular surgery
Krasnoyarsk
Regional Hospital
Krasnoyarsk
Federal Center of Prophylactic Medicine
Moscow
About this study
Official title: High Frequency Guided Renal Artery Denervation for Improving Outcome of Renal Ablation Procedure
To increase the number of responders using HFS-guided renal artery denervation (RDN) in patients with resistant and moderate resistant hypertension
- Conditions
- Hypertension
- Being tested
- Renal denervation guided by HFS, Renal denervation as standard procedure
- Keywords
- Renal denervation, Ablation
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal denervation guided by HFSDevice
Renal denervation as standard procedureDevice
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (RDN guided by HFS) | Experimental | Renal arteries were assessed for suitability of ablation by renal angiography. The real-time 3-dimensional aorta-renal artery maps were reconstructed with the use of navigation system and ablation catheter via femoral artery access. After that high-frequency stimulation (HFS) was used before the initial and after each radiofrequency (RF) delivery within the renal artery. RDN was considered to have been achieved when the sudden increase of blood pressure (> 15 mm Hg from invasive arterial monitoring) was eliminated in response to HFS.
RF ablations of 8-12 watts (impedance drop >10%) were applied discretely from the first distal main renal artery bifurcation all the way back to the ostium. The duration of each RF delivery was 60-120 sec, and up to 6 lesions (separated by > 5 mm) were performed both longitudinally and rotationally within each renal artery. Receives: Device: Renal denervation guided by HFS |
| Group 2 (RDN as standard procedure) | Active comparator | Renal arteries were assessed for suitability of ablation by renal angiography. The real-time 3-dimensional aorta-renal artery maps were reconstructed with the use of navigation system and ablation catheter via femoral artery access.
RF ablations of 8-12 watts (impedance drop >10%) were applied discretely from the first distal main renal artery bifurcation all the way back to the ostium. The duration of each RF delivery was 60-120 sec, and up to 6 lesions (separated by > 5 mm) were performed both longitudinally and rotationally within each renal artery. High-frequency stimulation (HFS) was performed before and after RDN to just to verify the response of BP Receives: Device: Renal denervation as standard procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of responders to renal denervation procedure
Measured: 12 month
Secondary outcomes (2)
complications rate
Measured: 12 month
cross-over rate
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startFeb 2013
- Primary completionDec 2015 (estimated)
- Study completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02608632
- Sponsor's protocol ID
- 7452RDNHFS
- Status last verified
- Nov 2015
- First submitted
- 17 Nov 2015
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Frequency Guided Renal Artery Denervation for Improving Outcome of Renal Ablation Procedure
- ClinicalTrials.gov ID
- NCT02608632
- Acronym / sponsor ID
- 7452RDNHFS
- Conditions
- Hypertension
- Keywords
- Renal denervation, Ablation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Meshalkin Research Institute of Pathology of CirculationResearch network
- Study start
- Feb 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 20 Nov 2015 (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.
To increase the number of responders using HFS-guided renal artery denervation (RDN) in patients with resistant and moderate resistant hypertension
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (RDN guided by HFS) | Experimental | Device: Renal denervation guided by HFSRenal arteries were assessed for suitability of ablation by renal angiography. The real-time 3-dimensional aorta-renal artery maps were reconstructed with the use of navigation system and ablation catheter via femoral artery access. After that high-frequency stimulation (HFS) was used before the initial and after each radiofrequency (RF) delivery within the renal artery. RDN was considered to have been achieved when the sudden increase of blood pressure (> 15 mm Hg from invasive arterial monitoring) was eliminated in response to HFS. RF ablations of 8-12 watts (impedance drop >10%) were applied discretely from the first distal main renal artery bifurcation all the way back to the ostium. The duration of each RF delivery was 60-120 sec, and up to 6 lesions (separated by > 5 mm) were performed both longitudinally and rotationally within each renal artery. |
| Group 2 (RDN as standard procedure) | Active comparator | Device: Renal denervation as standard procedureRenal arteries were assessed for suitability of ablation by renal angiography. The real-time 3-dimensional aorta-renal artery maps were reconstructed with the use of navigation system and ablation catheter via femoral artery access. RF ablations of 8-12 watts (impedance drop >10%) were applied discretely from the first distal main renal artery bifurcation all the way back to the ostium. The duration of each RF delivery was 60-120 sec, and up to 6 lesions (separated by > 5 mm) were performed both longitudinally and rotationally within each renal artery. High-frequency stimulation (HFS) was performed before and after RDN to just to verify the response of BP |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Office-based systolic blood pressure of ≥140/90 mm Hg and <160/100 mm Hg (moderate resistant hypertension) or ≥160/100 mm Hg (severe resistant hypertension), despite treatment with 3 antihypertensive drugs (including a diuretic).
- A glomerular filtration rate ≥45 mL/min/1⋅73 m2, with modification of diet using a renal disease formula.
Key exclusion criteria (6 listed)
- Secondary causes of hypertension
- Severe renal artery stenosis or dual renal arteries
- Congestive heart failure
- Left ventricular ejection fraction <35%
- Previous renal artery stenting or angioplasty
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 denervation guided by HFS | Device | Group 1 (RDN guided by HFS) |
| Renal denervation as standard procedure | Device | Group 2 (RDN as standard procedure) |
Primary outcome
number of responders to renal denervation procedure
Time frame: 12 month
2 secondary outcomes
complications rate
Time frame: 12 month
cross-over rate
Time frame: 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Renal denervation guided by HFS and Renal denervation as standard procedure in people with Hypertension, run by Meshalkin Research Institute of Pathology of Circulation at 3 sites in Russia.
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 2 inclusion and 6 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 20 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Russia. 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?
number of responders to renal denervation procedure (time frame: 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Nov 2015.