Resistant HypertensionPhase 2/3RAPID IINCT01939392
Rapid Renal Sympathetic Denervation for Resistant Hypertension II
A Phase 2/3 study testing Renal Denervation (OneShot™ Renal Denervation System) in people with Resistant Hypertension and Uncontrolled Hypertension, run by Medtronic Endovascular at 1 site in Italy.
Trial summary
This is a global, multi-center, prospective, randomized, controlled study of the safety and effectiveness of renal denervation with the OneShot Renal Denervation System in patients with uncontrolled hypertension. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Resistant Hypertension, Uncontrolled Hypertension, Renal Artery Ablation
- What is being tested?
- Renal Denervation (OneShot™ Renal Denervation System)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2013to Sep 2018
- Phase
- Phase 2/3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individual has a systolic blood pressure ≥ 160 mmHg based on an average of three office blood pressure readings.
- Stable drug regimen including three or more anti-hypertensive medications including a diuretic
Who cannot join
- Renal anatomy unsuitable for treatment
- Presence of hemodynamically significant valvular heart disease for which reduction of blood pressure would be considered hazardous
- Patient has Type I diabetes
- Has scheduled or planned surgery within the next 6 months
- Individual is pregnant nursing or plans to be pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rapid Renal Sympathetic Denervation for Resistant Hypertension Using the OneShot Renal Denervation System II
This is a global, multi-center, prospective, randomized, controlled study of the safety and effectiveness of renal denervation with the OneShot Renal Denervation System in patients with uncontrolled hypertension.
- Being tested
- Renal Denervation (OneShot™ Renal Denervation System)
- Keywords
- Resistant hypertension, Uncontrolled hypertension, Renal artery ablation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal Denervation (OneShot™ Renal Denervation System)Device
Also called OneShot Ablation system, Catheter-based renal denervation
| Study group | Role | What they receive |
|---|---|---|
| Renal Denervation | Experimental | Subjects randomized to the Renal Denervation arm will receive bilateral renal ablation with the OneShot system and be maintained on antihypertensive medication. Receives: Device: Renal Denervation (OneShot™ Renal Denervation System) |
| Optimal Medical Therapy | No intervention | Subjects randomized to the control arm will be maintained on antihypertensive medications. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse event (MAE) rate through 30 days post randomization
Measured: 30 days
Change in office systolic blood pressure (SBP) from baseline to 6 months post-randomization
Measured: 6 months
Secondary outcomes (4)
Acute Procedural Safety
Measured: 30 days
Chronic procedural safety
Measured: 6 months
Reduction in SBP by >10 mmHg at 6 months
Measured: 6 months
Changes in office SBP and diastolic blood pressure (DBP) from baseline to follow-up visits
Measured: 6, 12, 24, and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionSep 2015 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resistant 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Endovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dierk Scheinert, MD, Principal investigator, Park-Krankenhaus LiepzigGuiseppe Mancia, MD, Principal investigator, Universita Minano-Bicocca, Ospedale San Gerardo di Monza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01939392
- Sponsor's protocol ID
- CP-1003
- Acronym
- RAPID II
- Status last verified
- Aug 2015
- First submitted
- 6 Sep 2013
- Last updated
- 18 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Renal Sympathetic Denervation for Resistant Hypertension Using the OneShot Renal Denervation System II
- ClinicalTrials.gov ID
- NCT01939392
- Acronym / sponsor ID
- RAPID II / CP-1003
- Keywords
- Resistant hypertension, Uncontrolled hypertension, Renal artery ablation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medtronic EndovascularIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 11 Sep 2013 (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.
This is a global, multi-center, prospective, randomized, controlled study of the safety and effectiveness of renal denervation with the OneShot Renal Denervation System in patients with uncontrolled hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Renal Denervation | Experimental | Device: Renal Denervation (OneShot™ Renal Denervation System)Subjects randomized to the Renal Denervation arm will receive bilateral renal ablation with the OneShot system and be maintained on antihypertensive medication. |
| Optimal Medical Therapy | No intervention | –Subjects randomized to the control arm will be maintained on antihypertensive medications. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Individual has a systolic blood pressure ≥ 160 mmHg based on an average of three office blood pressure readings.
- Stable drug regimen including three or more anti-hypertensive medications including a diuretic
Key exclusion criteria (5 listed)
- Renal anatomy unsuitable for treatment
- Presence of hemodynamically significant valvular heart disease for which reduction of blood pressure would be considered hazardous
- Patient has Type I diabetes
- Has scheduled or planned surgery within the next 6 months
- Individual is pregnant nursing or plans to be pregnant
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 (OneShot™ Renal Denervation System)Also: OneShot Ablation system, Catheter-based renal denervation | Device | Renal Denervation |
Primary outcome
Major adverse event (MAE) rate through 30 days post randomization
Time frame: 30 days
Change in office systolic blood pressure (SBP) from baseline to 6 months post-randomization
Time frame: 6 months
4 secondary outcomes
Acute Procedural Safety
Time frame: 30 days
Chronic procedural safety
Time frame: 6 months
Reduction in SBP by >10 mmHg at 6 months
Time frame: 6 months
Changes in office SBP and diastolic blood pressure (DBP) from baseline to follow-up visits
Time frame: 6, 12, 24, and 36 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 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.
Dierk Scheinert, MD principal investigator
Park-Krankenhaus Liepzig
Guiseppe Mancia, MD principal investigator
Universita Minano-Bicocca, Ospedale San Gerardo di Monza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Renal Denervation (OneShot™ Renal Denervation System) in people with Resistant Hypertension and Uncontrolled Hypertension, run by Medtronic Endovascular at 1 site in Italy.
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 5 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: withdrawn, as of the sponsor's last update on 18 Aug 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 Italy. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Major adverse event (MAE) rate through 30 days post randomization (time frame: 30 days). The study lists 2 primary outcomes in all. 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 18 Aug 2015.