Renal Sympathetic Denervation for the Management of Chronic Hypertension (RELIEF)

June 28, 2016 updated by: Vivek Reddy

Despite the development of numerous drug therapies designed to treat hypertension, it remains a considerable and poorly managed health, social and economic burden. For various reasons, including the significant health care costs of treatment, there are estimates that up to 65% of hypertensive patients have untreated and/or uncontrolled blood pressure (BP).

Aside from its impact on renal function, chronic hypertension significantly increases the risk for stroke, coronary artery disease, heart failure, and vascular disease. It is believed to be involved in the progression of cardiac arrhythmias. This link between hypertension and cardiovascular health has been well described; as has their combined effect on the aging and obesity-battling Western world.

The recently published results of the Symplicity HTN-2 trial (Renal sympathetic denervation in patients with treatment resistant hypertension) establishing the therapeutic benefit of catheter-based renal sympathetic denervation for hypertension, have enormous potential for the management of a large and challenging patient population. The proposed, multicenter trial will attempt to confirm and expand on this promising data by conducting a double-blinded, placebo-controlled trial.

Patients may qualify to participate in this research study if their doctor has determined that they have drug-resistant, chronic hypertension.

Overall participation in this research study should be about 13 months which includes about 1 month to start the study procedure and 12 months of follow-up after the study procedure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients who qualify for the study and provide consent will undergo a renal angiogram in order to assess suitability for catheter-based renal sympathetic denervation. A renal angiogram is an x-ray study of the blood vessels in the kidney to evaluate for blockage, and abnormalities that could be affecting the blood supply to the kidney. It is performed by injecting contrast dye through a catheter (a tiny tube) into the blood vessels of the kidney. The study doctor will assess whether the renal arteries are suitable to receive catheter-based renal denervation.

Both groups will receive sedation or anesthesia prior to the beginning of the procedure.

The first group will undergo catheter-based sympathetic renal denervation. Renal Sympathetic Denervation is a procedure that uses a catheter probe inserted into the renal (kidney) artery that deactivates the nerves that are linked to high blood pressure.

The second group will only receive renal angiography without the delivery of ablative energy.

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • 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

  • Czech Republic
      • Brno, Czech Republic, 53, 656 91
        • Fakultni Nemocnice u sv. Anny v Brne
      • Prague, Czech Republic, 15030
        • Na Homolce 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

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ≥ 18 and ≤ 85 years of age
  • Uncontrolled hypertension (defined as SBP ≥ 140 mmHg during 24Hr Ambulatory BP monitoring)
  • Current treatment with ≥ 3 anti-hypertensive drugs (including at least one diuretic)
  • Accessibility of renal vasculature
  • Ability to understand the requirements of the study
  • Willingness to adhere to study restrictions and comply with all post-procedural follow-up requirements

Exclusion Criteria:

  • Secondary cause of hypertension
  • White coat hypertension
  • Estimated GFR < 45
  • Type 1 Diabetes
  • Known renovascular abnormalities (eg, renal artery stenosis, previous renal artery stenting or angioplasty)
  • Life expectancy <1 year for any medical condition

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Biosense Webster Celcius Thermacool catheter
These subjects will undergo catheter-based sympathetic renal denervation. Ablation arm
Device: Biosense Webster Celcius Thermacool catheter
catheter-based sympathetic renal denervation
Other Names:
  • sympathetic renal denervation
  • Ablation arm
No Intervention: renal angiogram only
Control Group: Control arm will not receive intervention but will be followed for 1 year.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in 24-hour ambulatory BP
Time Frame: baseline and at 6 months
Differences in 24-hour ambulatory blood pressure measurements recorded at baseline and at 6 months for each patient.
baseline and at 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in office BP
Time Frame: baseline, 6 months, and 12 months
Difference in office blood pressure measurements at 6 months and at 12 months as compared to baseline.
baseline, 6 months, and 12 months
change in ambulatory BP
Time Frame: baseline and at 12 months
Difference in 24 hour ambulatory blood pressure measurements at 12 months compared to baseline
baseline and at 12 months
Renal artery dimensions
Time Frame: baseline and at 6 months
Change in renal artery dimensions at 6 months.
baseline and at 6 months
Creatinine
Time Frame: baseline and at 6 months
Differences in creatinine measurements recorded at baseline and at 6 months for each patient.
baseline and at 6 months

Collaborators and Investigators

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

Sponsor

Vivek Reddy

Collaborators

Biosense Webster, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2011

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

June 12, 2012

First Submitted That Met QC Criteria

June 22, 2012

First Posted (Estimate)

June 26, 2012

Study Record Updates

Last Update Posted (Estimate)

June 29, 2016

Last Update Submitted That Met QC Criteria

June 28, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCO 11-0965

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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