HypertensionHTN-4NCT01972139
Renal Denervation in Patients With Uncontrolled Hypertension - SYMPLICITY HTN-4
A study testing Renal Denervation using the Symplicity Renal Denervation System and Renal Angiography in people with Hypertension and Vascular Diseases, run by Medtronic Vascular at 3 sites in United States.
Trial summary
An international, multi-center, prospective, blinded, randomized, controlled trial. The objective is to demonstrate that catheter-based renal denervation is an effective and safe treatment for uncontrolled hypertension. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertension, Vascular Diseases, Cardiovascular Diseases
- What is being tested?
- Renal Denervation using the Symplicity Renal Denervation System and Renal Angiography
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2013to Jan 2017
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individual is on maximally tolerated stable medication regimen including 3 or more anti-hypertensive medications of different classes, one of which must be a thiazide or thiazide-like diuretic
- Individual has office SBP greater than or equal to 140mmHg and less than 160mmHg
- Individual has ABPM average SBP greater than or equal to 135 mmHg
Who cannot join
- Individual lacks appropriate renal artery anatomy
- Individual has eGFR of less than 30
- Individual has Type I diabetes mellitus
- Individual has had one or more episodes of orthostatic hypotension
- Individual requires chronic oxygen other than nocturnal respiratory support for sleep apnea
- Individual has primary pulmonary hypertension
Show all 9Show fewer
- Individual has other concomitant conditions that may adversely affect the patient or the study outcomes
- Individual is pregnant, nursing or planning to be pregnant
- Individual has had a previous organ transplant
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Piedmont Hospital
Atlanta, Georgia, 30309
Medical University of South Carolina
Charleston, South Carolina, 29425
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Renal Denervation Using the SYMPLICITY Renal Denervation System in Patients With Uncontrolled Hypertension - SYMPLICITY HTN-4
An international, multi-center, prospective, blinded, randomized, controlled trial. The objective is to demonstrate that catheter-based renal denervation is an effective and safe treatment for uncontrolled hypertension.
Read the detailed description
After the 6 month follow-up required testing has been completed, control group subjects would be unblinded to their randomization group and would have an option, at the discretion of the Investigator and with written concurrence of the medical monitor, to be treated with renal denervation procedure. However, after enrollment closure, subjects previously randomized were no longer allowed to cross-over.
- Conditions
- Hypertension, Vascular Diseases, Cardiovascular Diseases
- Being tested
- Renal Denervation using the Symplicity Renal Denervation System, Sham Renal Denervation, Renal Angiography
- Keywords
- Uncontrolled hypertension, blood pressure, renal denervation, HTN-4, SYMPLICITY
- Medical subject headings
- Hypertension, Vascular Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal Denervation using the Symplicity Renal Denervation SystemDevice
Subjects randomized to the renal denervation group underwent angiography and renal denervation.
Sham Renal DenervationOther
Prior to enrollment closure, subjects were treated with sham renal denervation. After enrollment closure, subjects previously enrolled were no longer eligible to cross-over.
Renal AngiographyDevice
Subjects who met all criteria after the screening period did undergo a renal artery angiogram to evaluate renal artery anatomy. Only subjects with eligible renal artery anatomy were randomized.
| Study group | Role | What they receive |
|---|---|---|
| Renal Denervation | Experimental | Subjects are treated with the renal denervation procedure after randomization. Receives: Device: Renal Denervation using the Symplicity Renal Denervation System; Device: Renal Angiography |
| Control | Other | Subjects randomized prior to enrollment closure were treated with sham renal denervation (angiography only). Once enrollment was closed and the protocol revised, no control subjects crossed-over. Receives: Other: Sham Renal Denervation; Device: Renal Angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reaching BP Goal
Measured: 6 months post-randomization
Incidence of Major Adverse Events through 1 month post-procedure (Renal artery stenosis measured at 6 months)
Measured: Baseline 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 posted30 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionJul 2014
- Study completionJan 2017
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Vascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Kandzari, MD, Principal investigator, Piedmont Heart InstituteMichael Weber, MD, Principal investigator, SUNY Downstate College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01972139
- Sponsor's protocol ID
- HTN-4
- Acronym
- HTN-4
- Status last verified
- Apr 2017
- First submitted
- 22 Oct 2013
- Last updated
- 26 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Denervation Using the SYMPLICITY Renal Denervation System in Patients With Uncontrolled Hypertension - SYMPLICITY HTN-4
- ClinicalTrials.gov ID
- NCT01972139
- Acronym / sponsor ID
- HTN-4 / HTN-4
- Conditions
- Hypertension, Vascular Diseases, Cardiovascular Diseases
- Keywords
- Uncontrolled hypertension, blood pressure, renal denervation, HTN-4, SYMPLICITY
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Medtronic VascularIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 30 Oct 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.
An international, multi-center, prospective, blinded, randomized, controlled trial. The objective is to demonstrate that catheter-based renal denervation is an effective and safe treatment for uncontrolled hypertension.
Detailed description
After the 6 month follow-up required testing has been completed, control group subjects would be unblinded to their randomization group and would have an option, at the discretion of the Investigator and with written concurrence of the medical monitor, to be treated with renal denervation procedure. However, after enrollment closure, subjects previously randomized were no longer allowed to cross-over.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Renal Denervation | Experimental | Device: Renal Denervation using the Symplicity Renal Denervation System, Device: Renal AngiographySubjects are treated with the renal denervation procedure after randomization. |
| Control | Other | Other: Sham Renal Denervation, Device: Renal AngiographySubjects randomized prior to enrollment closure were treated with sham renal denervation (angiography only). Once enrollment was closed and the protocol revised, no control subjects crossed-over. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Individual is on maximally tolerated stable medication regimen including 3 or more anti-hypertensive medications of different classes, one of which must be a thiazide or thiazide-like diuretic
- Individual has office SBP greater than or equal to 140mmHg and less than 160mmHg
- Individual has ABPM average SBP greater than or equal to 135 mmHg
Key exclusion criteria (9 listed)
- Individual lacks appropriate renal artery anatomy
- Individual has eGFR of less than 30
- Individual has Type I diabetes mellitus
- Individual has had one or more episodes of orthostatic hypotension
- Individual requires chronic oxygen other than nocturnal respiratory support for sleep apnea
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 using the Symplicity Renal Denervation SystemSubjects randomized to the renal denervation group underwent angiography and renal denervation. | Device | Renal Denervation |
| Sham Renal DenervationPrior to enrollment closure, subjects were treated with sham renal denervation. After enrollment closure, subjects previously enrolled were no longer eligible to cross-over. | Other | Control |
| Renal AngiographySubjects who met all criteria after the screening period did undergo a renal artery angiogram to evaluate renal artery anatomy. Only subjects with eligible renal artery anatomy were randomized. | Device | Control, Renal Denervation |
Primary outcome
Reaching BP Goal
Time frame: 6 months post-randomization
Incidence of Major Adverse Events through 1 month post-procedure (Renal artery stenosis measured at 6 months)
Time frame: Baseline to 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 26 Apr 2017.
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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.
David Kandzari, MD principal investigator
Piedmont Heart Institute
Michael Weber, MD principal investigator
SUNY Downstate College of Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Renal Denervation using the Symplicity Renal Denervation System and Renal Angiography in people with Hypertension and Vascular Diseases, run by Medtronic Vascular at 3 sites in United States.
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 3 inclusion and 9 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 26 Apr 2017. 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 United States. 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.
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?
Reaching BP Goal (time frame: 6 months post-randomization). 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 26 Apr 2017.