HypertensionEnligHTN-INCT01438229

Safety and Efficacy Study of Renal Artery Ablation in Resistant Hypertension Patients

A study testing St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002) in people with Hypertension, run by Abbott Medical Devices at 4 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This is a prospective, multicenter, feasibility study on the safety and efficacy of renal denervation in patients with 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?: St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 47 participants
Where: 4 sitesin 2 countries
Study dates: Oct 2011to Jul 2014
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 systolic blood pressure that remains ≥160 mmHg (≥150 mmHg for patient with type 2 diabetes) despite the stable use of ≥3 antihypertensive medications concurrently at maximally tolerated doses, of which one is a diuretic, for a minimum of 14 days prior to enrollment
Age ≥18 and ≤80 years old
Able and willing to provide written informed consent to participate in the study
Able and willing to comply with the required follow-up schedule

Who cannot join

Prior renal artery intervention (balloon angioplasty or stenting)
Evidence of renal artery atherosclerosis (defined as a stenotic severity of >30%) in either renal artery
Multiple main renal arteries in either kidney
Main renal arteries <4 mm in diameter or <20 mm in length
eGFR of <45 mL/min per 1.73 m2 using the MDRD formula
Type 1 diabetes
Renovascular hypertension or hypertension secondary to other renal disorders (glomerulonephritis, polycystic kidney disease, end-stage renal failure)
Others

Trial locations and contacts

4 sites in 2 countries.

Country

City, postcode or hospital

4 sites in 2 countries

Australia3 sites

Royal Adelaide Hospital
Adelaide, South Australia, 5000
Flinders Medical Centre
Adelaide, South Australia, 5042
Monash Medical Centre
Melbourne, Victoria, 3168

Other trials in Australia

Greece1 site

Hippokration Hospital
Athens

Other trials in Greece

About this study

Official title: Ablation-induced Renal Sympathetic Denervation Trial

This is a prospective, multicenter, feasibility study on the safety and efficacy of renal denervation in patients with resistant hypertension.

Read the detailed description

Demonstrate the safety and efficacy of the St. Jude Medical Radiofrequency (RF) Renal Denervation System in the treatment of patients with resistant hypertension.

Safety Marker

All adverse events

Efficacy Marker

Office blood pressure

Conditions: Hypertension
Being tested: St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002)
Keywords: Catheter-based renal artery ablation, Hypertension, Resistant to Conventional Therapy
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002)Device
Catheter-based RF ablation in renal artery

Study groups in NCT01438229
Study group	Role	What they receive
renal artery ablation	Experimental	Catheter-based RF ablation in renal artery Receives: Device: St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002)

What is being measured

The primary outcome is the main question the study is designed to answer.

Adverse Events
All device or procedure related adverse events
Measured: 24 months
Office Systolic Blood Pressure Change
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.

Oct 2011Jul 2014

First posted22 Sep 2011 (estimated)
Study startOct 2011
Primary completionSep 2012
Study completionJul 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HypertensionStudies of the same condition, open and under way.
More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
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: 47 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01438229
Sponsor's protocol ID: CI-10-045-ID-HT
Other IDs: Arsenal
Acronym: EnligHTN-I
Status last verified: Feb 2019
First submitted: 19 Sep 2011
Last updated: 5 Feb 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension

All Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Ablation-induced Renal Sympathetic Denervation Trial
ClinicalTrials.gov ID: NCT01438229
Acronym / sponsor ID: EnligHTN-I / CI-10-045-ID-HT
Conditions: Hypertension
Keywords: Catheter-based renal artery ablation, Hypertension, Resistant to Conventional Therapy
Study type: Interventional
Recruitment status: Completed
Enrolment: 47 participants (actual)
Lead sponsor: Abbott Medical DevicesIndustry (pharma, biotech, devices)
Study start: Oct 2011
Primary completion: Sep 2012 (actual)
Study completion: Jul 2014 (actual)
First posted: 22 Sep 2011 (estimated)
Results: Posted 21 May 2015

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 prospective, multicenter, feasibility study on the safety and efficacy of renal denervation in patients with resistant hypertension.

Detailed description

Demonstrate the safety and efficacy of the St. Jude Medical Radiofrequency (RF) Renal Denervation System in the treatment of patients with resistant hypertension.

Safety Marker

All adverse events

Efficacy Marker

Office blood pressure

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
renal artery ablation	Experimental	Device: St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002)Catheter-based RF ablation in renal artery

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Office systolic blood pressure that remains ≥160 mmHg (≥150 mmHg for patient with type 2 diabetes) despite the stable use of ≥3 antihypertensive medications concurrently at maximally tolerated doses, of which one is a diuretic, for a minimum of 14 days prior to enrollment
Age ≥18 and ≤80 years old
Able and willing to provide written informed consent to participate in the study
Able and willing to comply with the required follow-up schedule

Key exclusion criteria (8 listed)

Prior renal artery intervention (balloon angioplasty or stenting)
Evidence of renal artery atherosclerosis (defined as a stenotic severity of >30%) in either renal artery
Multiple main renal arteries in either kidney
Main renal arteries <4 mm in diameter or <20 mm in length
eGFR of <45 mL/min per 1.73 m2 using the MDRD formula

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
St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002)Catheter-based RF ablation in renal artery	Device	renal artery ablation

Primary outcome

Adverse Events
Time frame: 24 months
All device or procedure related adverse events
Office Systolic Blood Pressure Change
Time frame: Baseline to 6 months

Results and safety

Results posted to the registry on 21 May 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Renal Artery Ablation	47	44

Primary outcome: Adverse Events

Time frame: 24 months. Number. Unit: percentage of participants

Measure	Renal Artery Ablation n = 46
Value	47.8

Population analysed: All subjects receiving renal artery ablation procedure

Primary outcome: Office Systolic Blood Pressure Change

Time frame: Baseline to 6 months. Mean (Standard Deviation). Unit: mmHg

Measure	Renal Artery Ablation n = 45
Value	-26 (25)

Renal Artery Ablation: p <0.0001, t-test, 2 sided

Population analysed: Subjects with both baseline and 6M follow up office blood pressure measurements

Adverse events

Time frame: 24 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Renal Artery Ablation	14 of 46 (30.4%)	32 of 46 (69.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hypertension

Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension

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.

Vasilias Papademetriou, MD principal investigator

First Cardioligy Clinic, Hippokration Hospital, University of Athens, Greece

Konstantinos Tsioufis, MD principal investigator

First Cardioligy Clinic, Hippokration Hospital, University of Athens, Greece

Stephen Worthley, MD principal investigator

Cardiovascular Investigation Unit, Royal Adelaide Hospital, Adelaide, Australia

4 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 8 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 5 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Australia, Greece. 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?

Yes. Results are posted in the registry (first posted 21 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Adverse Events (time frame: 24 months). 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?

On the ClinicalTrials.gov record for NCT01438229.

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 5 Feb 2019.