Safety and Efficacy Study of Renal Artery Ablation in Resistant Hypertension Patients (EnligHTN-I)

February 1, 2019 updated by: Abbott Medical Devices

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
47

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital
      • Adelaide, South Australia, Australia, 5042
        • Flinders Medical Centre
    • Victoria
      • Melbourne, Victoria, Australia, 3168
        • Monash Medical Centre
  • Greece
      • Athens, Greece
        • Hippokration Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: renal artery ablation
Catheter-based RF ablation in renal artery
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: 24 months
All device or procedure related adverse events
24 months
Office Systolic Blood Pressure Change
Time Frame: Baseline to 6 months
Baseline to 6 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Office Diastolic BP Change
Time Frame: Baseline to 6M
Baseline to 6M
Office Systolic BP Change
Time Frame: Baseline to 12M
Baseline to 12M
Office Systolic BP Change
Time Frame: Baseline to 18 months
Baseline to 18 months
Office Systolic BP Change
Time Frame: Baseline to 24 months
Baseline to 24 months
Office Diastolic BP Change
Time Frame: Baseline to 12 months
Baseline to 12 months
Office Diastolic BP Change
Time Frame: Baseline to 18 months
Baseline to 18 months
Office Diastolic BP Change
Time Frame: Baseline to 24 months
Baseline to 24 months
24hr Ambulatory Systolic BP Change
Time Frame: Baseline to 6 months
Average of readings taken every half hour during the course of a 24hr period wearing the ambulatory blood pressure monitor. Includes only subjects who completed the test at both baseline and follow up. If a subject refused to wear the monitor they were excluded.
Baseline to 6 months
24hr Ambulatory Systolic BP Change
Time Frame: Baseline to 12 months
Average of readings taken every half hour during the course of a 24hr period wearing the ambulatory blood pressure monitor. Includes only subjects who completed the test at both baseline and follow up. If a subject refused to wear the monitor they were excluded.
Baseline to 12 months
24hr Ambulatory Systolic BP Change
Time Frame: Baseline to 24 months
Average of readings taken every half hour during the course of a 24hr period wearing the ambulatory blood pressure monitor. Includes only subjects who completed the test at both baseline and follow up. If a subject refused to wear the monitor they were excluded.
Baseline to 24 months
24hr Ambulatory Diastolic BP Change
Time Frame: Baseline to 6 months
Average of readings taken every half hour during the course of a 24hr period wearing the ambulatory blood pressure monitor. Includes only subjects who completed the test at both baseline and follow up. If a subject refused to wear the monitor they were excluded.
Baseline to 6 months
24hr Ambulatory Diastolic BP Change
Time Frame: Baseline to 12 months
Average of readings taken every half hour during the course of a 24hr period wearing the ambulatory blood pressure monitor. Includes only subjects who completed the test at both baseline and follow up. If a subject refused to wear the monitor they were excluded.
Baseline to 12 months
24hr Ambulatory Diastolic BP Change
Time Frame: Baseline to 24 months
Average of readings taken every half hour during the course of a 24hr period wearing the ambulatory blood pressure monitor. Includes only subjects who completed the test at both baseline and follow up. If a subject refused to wear the monitor they were excluded.
Baseline to 24 months
Urine Albumin to Creatinine Ratio
Time Frame: Baseline
Baseline
Urine Albumin to Creatinine Ratio
Time Frame: 6 months
6 months
Urine Albumin to Creatinine Ratio
Time Frame: 12 months
12 months
Urine Albumin to Creatinine Ratio
Time Frame: 18 months
18 months
Urine Albumin to Creatinine Ratio
Time Frame: 24 months
24 months
Estimated Glomular Filtration Rate
Time Frame: Baseline

Calculated using Modifide Diet in Renal Disease formula.

estimated GFR = 186 x SerumCr-1.154 * age-0.203 * 1.212 (if patient is black) * 0.742 (if female)
Baseline
Estimated Glomular Filtration Rate
Time Frame: 6 months

Calculated using Modifide Diet in Renal Disease formula.

estimated GFR = 186 x SerumCr-1.154 * age-0.203 * 1.212 (if patient is black) * 0.742 (if female)
6 months
Estimated Glomular Filtration Rate
Time Frame: 12 months

Calculated using Modifide Diet in Renal Disease formula.

estimated GFR = 186 x SerumCr-1.154 * age-0.203 * 1.212 (if patient is black) * 0.742 (if female)
12 months
Estimated Glomular Filtration Rate
Time Frame: 18 months

Calculated using Modifide Diet in Renal Disease formula.

estimated GFR = 186 x SerumCr-1.154 * age-0.203 * 1.212 (if patient is black) * 0.742 (if female)
18 months
Estimated Glomular Filtration Rate
Time Frame: 24 months

Calculated using Modifide Diet in Renal Disease formula.

estimated GFR = 186 x SerumCr-1.154 * age-0.203 * 1.212 (if patient is black) * 0.742 (if female)
24 months
Cystatin C
Time Frame: Baseline
Baseline
Cystatin C
Time Frame: 6 months
6 months
Cystatin C
Time Frame: 12 months
12 months
Cystatin C
Time Frame: 18 months
18 months
Cystatin C
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abbott Medical Devices

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Vasilias Papademetriou, MD, First Cardioligy Clinic, Hippokration Hospital, University of Athens, Greece
  • Principal Investigator: Konstantinos Tsioufis, MD, First Cardioligy Clinic, Hippokration Hospital, University of Athens, Greece
  • Principal Investigator: Stephen Worthley, MD, Cardiovascular Investigation Unit, Royal Adelaide Hospital, Adelaide, Australia
  • Principal Investigator: Ian Meredith, MD, Monash Medical Centre, Melbourne, Australia
  • Principal Investigator: Derek Chew, MD, Flinders Medical Centre, Adelaide, AUSTRALIA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2011

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2012

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 19, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2011

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 22, 2011

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 5, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 1, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CI-10-045-ID-HT
  • Arsenal (OTHER: St Jude Medical)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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