Renal DenervationPhase 3NCT01874470
Renal Denervation by Allegro System in Patients With Resistant Hypertension
A Phase 3 study testing renal denervation and standard medication in people with Renal Denervation and Resistant Hypertension, run by Shanghai AngioCare Medical at 1 site in China.
Trial summary
The purpose of ALLEGRO-HTN trial is to evaluate the safety and effectiveness of renal denervation in subjects with resistant hypertension by using Allegro renal denervation system Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Renal Denervation, Resistant Hypertension, Standard Medication
- What is being tested?
- renal denervation and standard medication
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteChina
- Study dates
- May 2013to May 2014
- Phase
- Phase 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 - 65 years at time of randomization
- Stable medication regimen including 3 or more antihypertensive medications of different classes, including a diuretic (with no changes for a minimum of 4 weeks prior to screening) and no expected changes for at least 6 months
- 1) Office SBP and/or DBP ≥160/100 mm Hg ( ≥ 150/95 mmHg for type II diabetic patients) , 2) ABPM 24 hour average SBP and/or DBP ≥140 and/or 90 mmHg
- Main renal arteries with ≥4 mm diameter or with ≥20 mm treatable length (by visual estimation)
- eGFR≥45 mL/min/1.73 m2
- Written informed consent
Who cannot join
- Type 1 diabetes mellitus
- Secondary hypertension
- Has an implantable cardioverter defibrillator (ICD) or pacemaker
- Myocardial infarction, unstable angina pectoris, syncope, or a cerebrovascular accident within 6 months of the screening period
- Intravascular thrombosis or unstable atherosclerotic plaques
- Has hemodynamically significant valvular heart disease
Show all 15Show fewer
- Pregnant, nursing, or planning to be pregnant
- Any serious medical condition that may adversely affect the safety of the participant or the study
- Currently enrolled in another investigational drug or device trial
- Angiographic Exclusion Criteria:
- Renal artery stenosis (≥50%) or renal artery aneurysm in either renal artery
- History of prior renal artery intervention including balloon angioplasty or stenting
- Multiple renal arteries where the main renal artery is estimated to supply <75% of the kidney
- Main renal arteries with <4 mm diameter or with <20 mm treatable length (by visual estimation)
- Renal artery abnormalities
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of ALLEGRO-HTN trial is to evaluate the safety and effectiveness of renal denervation in subjects with resistant hypertension by using Allegro renal denervation system
- Being tested
- renal denervation, standard medication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
renal denervationDevice
Also called Allegro Renal Denervation System (AngioCare)
standard medicationOther
Also called Standard Medication: Continued usage of 3 or more antihypertensive medications of different classes, including a diuretic
| Study group | Role | What they receive |
|---|---|---|
| standard medication | Placebo comparator | Standard Medication: Continued usage of 3 or more antihypertensive medications of different classes, including a diuretic Receives: Other: standard medication |
| renal denervation | Experimental | Allegro Renal Denervation System (AngioCare) Receives: Device: renal denervation; Other: standard medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in office-based systolic blood pressure (SBP) from baseline to 6 months
Measured: 6 month
Secondary outcomes (5)
Change in average 24-hour SBP by ambulatory blood pressure monitoring (ABPM) from baseline to 6 months
Change in average 24-hour SBP by ambulatory blood pressure monitoring (ABPM) from baseline to 6 months
Measured: 6 month
• The incidence of major adverse events (MAE) at 1 month postrandomization
Measured: 1-month post randomization
Office SBP and DBP at 1, 3, 6 months postrandomization
Measured: up to 6 months
• Patient-recorded home systolic blood pressure at 1, 3, 6 months postrandomization
Measured: up to 6 months
• MAE at 6-month post-randomization, including new renal artery stenosis >60%
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2013 (estimated)
- Study startMay 2013
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal DenervationStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai AngioCare Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01874470
- Sponsor's protocol ID
- Allegro-HTN
- Status last verified
- Dec 2013
- First submitted
- 1 Jun 2013
- Last updated
- 20 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Denervation by Allegro System in Patients With Resistant Hypertension
- ClinicalTrials.gov ID
- NCT01874470
- Acronym / sponsor ID
- Allegro-HTN
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Shanghai AngioCare MedicalIndustry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 11 Jun 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.
The purpose of ALLEGRO-HTN trial is to evaluate the safety and effectiveness of renal denervation in subjects with resistant hypertension by using Allegro renal denervation system
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard medication | Placebo comparator | Other: standard medicationStandard Medication: Continued usage of 3 or more antihypertensive medications of different classes, including a diuretic |
| renal denervation | Experimental | Device: renal denervation, Other: standard medicationAllegro Renal Denervation System (AngioCare) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 - 65 years at time of randomization
- Stable medication regimen including 3 or more antihypertensive medications of different classes, including a diuretic (with no changes for a minimum of 4 weeks prior to screening) and no expected changes for at least 6 months
- 1) Office SBP and/or DBP ≥160/100 mm Hg ( ≥ 150/95 mmHg for type II diabetic patients) , 2) ABPM 24 hour average SBP and/or DBP ≥140 and/or 90 mmHg
- Main renal arteries with ≥4 mm diameter or with ≥20 mm treatable length (by visual estimation)
- eGFR≥45 mL/min/1.73 m2
Key exclusion criteria (15 listed)
- Type 1 diabetes mellitus
- Secondary hypertension
- Has an implantable cardioverter defibrillator (ICD) or pacemaker
- Myocardial infarction, unstable angina pectoris, syncope, or a cerebrovascular accident within 6 months of the screening period
- Intravascular thrombosis or unstable atherosclerotic plaques
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 denervationAlso: Allegro Renal Denervation System (AngioCare) | Device | renal denervation |
| standard medicationAlso: Standard Medication: Continued usage of 3 or more antihypertensive medications of different classes, including a diuretic | Other | renal denervation, standard medication |
Primary outcome
Change in office-based systolic blood pressure (SBP) from baseline to 6 months
Time frame: 6 month
5 secondary outcomes
Change in average 24-hour SBP by ambulatory blood pressure monitoring (ABPM) from baseline to 6 months
Time frame: 6 month
• The incidence of major adverse events (MAE) at 1 month postrandomization
Time frame: 1-month post randomization
Office SBP and DBP at 1, 3, 6 months postrandomization
Time frame: up to 6 months
• Patient-recorded home systolic blood pressure at 1, 3, 6 months postrandomization
Time frame: up to 6 months
• MAE at 6-month post-randomization, including new renal artery stenosis >60%
Time frame: up to 6 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2016.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing renal denervation and standard medication in people with Renal Denervation and Resistant Hypertension, run by Shanghai AngioCare Medical at 1 site in China.
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 6 inclusion and 15 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: stopped early, as of the sponsor's last update on 20 Oct 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 China. 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.
What does this phase mean?
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 stopped early. 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?
Change in office-based systolic blood pressure (SBP) from baseline to 6 months (time frame: 6 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 Oct 2016.