Adults With Uncontrolled HypertensionHTN-IndiaNCT01632943
Single-arm Study of Symplicity™ Renal Denervation System in Patients With Uncontrolled HyperTensioN in India
A study testing Symplicity renal denervation system in people with Adults With Uncontrolled Hypertension, run by Medtronic Vascular at 1 site in India.
Trial summary
This study is to evaluate efficacy and safety of renal denervation in the treatment of uncontrolled hypertension. This study will enroll a minimum of 40 and a maximum of 45 subjects. The study will be conducted at up to 8 actively enrolling investigational sites. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Adults With Uncontrolled Hypertension
- What is being tested?
- Symplicity renal denervation system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteIndia
- Study dates
- Oct 2013to Dec 2014
- 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 18 and 80 years old at time of treatment.
- Individual is receiving a stable medication regimen including 3 or more anti-hypertensive medications of different classes, of which one must be a diuretic that is expected to be maintained without changes for at least 6 months.
- Individual has an office systolic blood pressure of 160 mm Hg based on an average of 3 blood pressure readings measured at screening visits
- Individual or legally authorized representative agrees to have all study procedures performed, and is competent and willing to provide written, informed consent to participate in this clinical study.
Who cannot join
- Individual has renal artery anatomy that is ineligible for treatment including:
- Main renal arteries with less than 4 mm diameter or with less than 20 mm treatable length
- Multiple renal arteries where the main renal artery is estimated to supply less than 75 percent of the kidney.
- Renal artery stenosis more than 50 percent or renal artery aneurysm in either renal artery.
- A history of prior renal artery intervention including balloon angioplasty or stenting.
- Individual has an estimated glomerular filtration rate of less than 45mL per min per 1.73m2, using the MDRD calculation.
Show all 20Show fewer
- Individual has had more than 1 in-patient hospitalization for a hypertensive crisis within the past year.
- Individual has type 1 diabetes mellitus.
- Individual has had 1 or more episodes of symptomatic orthostatic hypotension within the past year or during the screening process.
- Individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea.
- Individual has primary pulmonary hypertension.
- Individual has known secondary causes of hypertension, such as untreated pheochromocytoma, Cushing's Disease, coarctation of the aorta, hyperthyroidism, or hyperparathyroidism.
- Individual has experienced a myocardial infarction, unstable angina pectoris, syncope, or a cerebrovascular accident within 6 months of the screening period, or has widespread atherosclerosis, with documented intravascular thrombosis or unstable plaques.
- Individual has a scheduled or planned surgery or cardiovascular intervention in the next 6 months.
- Individual has a condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement using the protocol specified automatic blood pressure monitor
- Individual has severe cardiac valve stenosis for which, in the opinion of the Investigator, a significant reduction of blood pressure is contraindicated.
- Individual has any serious medical condition, which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant or the study
- Individual is pregnant, nursing or planning to be pregnant.
- Individual has a known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or would be unlikely or unable to comply with study follow-up requirements.
- Individual is currently enrolled in another investigational drug or device trial. For the purposes of this protocol, participants involved in extended follow-up trials for products that were investigational but are currently commercially available are not considered enrolled in an investigational trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Multi-center, Non-randomized, Controlled Trial in India to Evaluate Efficacy and Safety of Renal Denervation in the Treatment of Uncontrolled Hypertension
This study is to evaluate efficacy and safety of renal denervation in the treatment of uncontrolled hypertension. This study will enroll a minimum of 40 and a maximum of 45 subjects. The study will be conducted at up to 8 actively enrolling investigational sites. The primary endpoint is change in Office Systolic Blood Pressure from baseline to 6 months post-procedure.
Read the detailed description
Estimated enrollment Start: May 2013 (estimated 90 day duration) Estimated last follow-up: September 2013 Follow-Up Duration: Subjects in the intent-to-treat population will be followed from enrollment through 6 months ±14 days for the effectiveness and safety endpoints
- Conditions
- Adults With Uncontrolled Hypertension
- Being tested
- Symplicity renal denervation system
- Keywords
- Uncontrolled Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Symplicity renal denervation systemDevice
Previous research has shown that disrupting the nerves of the kidney may successfully decrease blood pressure.
A less invasive approach to disrupting these nerves is to apply a brief high temperature near the nerves (renal denervation). This can now be done with an experimental medical device called the Symplicity renal denervation system. The System includes a catheter that is inserted into your blood vessels and an RF-generator.
| Study group | Role | What they receive |
|---|---|---|
| Symplicity renal denervation system | Experimental | Not described Receives: Device: Symplicity renal denervation system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: Change in Office Systolic Blood Pressure from baseline to 6 months post-procedure
Measured: 6 months post procedure
Secondary outcomes (1)
Safety: Incidence of Major Adverse Events (MAE),through 6 months post-procedure
Measured: 6 months post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2012 (estimated)
- Study startOct 2013
- Primary completionNov 2014
- Study completionDec 2014
Why it stopped: Study Enrollment was stopped pending review of another study in the same therapeutic area.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adults With Uncontrolled 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Vascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01632943
- Sponsor's protocol ID
- 10054637DOC
- Acronym
- HTN-India
- Status last verified
- Feb 2017
- First submitted
- 29 Jun 2012
- Last updated
- 7 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Non-randomized, Controlled Trial in India to Evaluate Efficacy and Safety of Renal Denervation in the Treatment of Uncontrolled Hypertension
- ClinicalTrials.gov ID
- NCT01632943
- Acronym / sponsor ID
- HTN-India / 10054637DOC
- Conditions
- Adults With Uncontrolled Hypertension
- Keywords
- Uncontrolled Hypertension
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study Enrollment was stopped pending review of another study in the same therapeutic area.
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Medtronic VascularIndustry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Study start
- Oct 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 4 Jul 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.
This study is to evaluate efficacy and safety of renal denervation in the treatment of uncontrolled hypertension. This study will enroll a minimum of 40 and a maximum of 45 subjects. The study will be conducted at up to 8 actively enrolling investigational sites. The primary endpoint is change in Office Systolic Blood Pressure from baseline to 6 months post-procedure.
Detailed description
Estimated enrollment Start: May 2013 (estimated 90 day duration) Estimated last follow-up: September 2013 Follow-Up Duration: Subjects in the intent-to-treat population will be followed from enrollment through 6 months ±14 days for the effectiveness and safety endpoints
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Symplicity renal denervation system | Experimental | Device: Symplicity renal denervation system |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Individual is 18 and 80 years old at time of treatment.
- Individual is receiving a stable medication regimen including 3 or more anti-hypertensive medications of different classes, of which one must be a diuretic that is expected to be maintained without changes for at least 6 months.
- Individual has an office systolic blood pressure of 160 mm Hg based on an average of 3 blood pressure readings measured at screening visits
- Individual or legally authorized representative agrees to have all study procedures performed, and is competent and willing to provide written, informed consent to participate in this clinical study.
Key exclusion criteria (20 listed)
- Individual has renal artery anatomy that is ineligible for treatment including:
- Individual has an estimated glomerular filtration rate of less than 45mL per min per 1.73m2, using the MDRD calculation.
- Individual has had more than 1 in-patient hospitalization for a hypertensive crisis within the past year.
- Individual has type 1 diabetes mellitus.
- Individual has had 1 or more episodes of symptomatic orthostatic hypotension within the past year or during the screening process.
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 |
|---|---|---|
| Symplicity renal denervation systemPrevious research has shown that disrupting the nerves of the kidney may successfully decrease blood pressure. A less invasive approach to disrupting these nerves is to apply a brief high temperature near the nerves (renal denervation). This can now be done with an experimental medical device called the Symplicity renal denervation system. The System includes a catheter that is inserted into your blood vessels and an RF-generator. | Device | Symplicity renal denervation system |
Primary outcome
Efficacy: Change in Office Systolic Blood Pressure from baseline to 6 months post-procedure
Time frame: 6 months post procedure
1 secondary outcome
Safety: Incidence of Major Adverse Events (MAE),through 6 months post-procedure
Time frame: 6 months post procedure
Results and safety
The study was stopped early (reason given: Study Enrollment was stopped pending review of another study in the same therapeutic area.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 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.
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 study testing Symplicity renal denervation system in people with Adults With Uncontrolled Hypertension, run by Medtronic Vascular at 1 site in India.
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 4 inclusion and 20 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 7 Feb 2017. 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 India. 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 was stopped early (reason given: Study Enrollment was stopped pending review of another study in the same therapeutic area.). 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?
Efficacy: Change in Office Systolic Blood Pressure from baseline to 6 months post-procedure (time frame: 6 months post procedure). 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 7 Feb 2017.