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RELIEF: Renal Sympathetic Denervation for the Management of Chronic Hypertension

Sponsor
Vivek Reddy (Other)
Overall Status
Completed
CT.gov ID
NCT01628172
Collaborator
Biosense Webster, Inc. (Industry)
96
Enrollment
2
Locations
2
Arms
37.9
Duration (Months)
48
Patients Per Site
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Biosense Webster Celcius Thermacool catheter
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
96 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Renal Sympathetic Denervation for the Management of Chronic Hypertension
Study Start Date :
Jan 1, 2011
Actual Primary Completion Date :
Mar 1, 2014
Actual Study Completion Date :
Mar 1, 2014

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. Change in 24-hour ambulatory BP [baseline and at 6 months]

      Differences in 24-hour ambulatory blood pressure measurements recorded at baseline and at 6 months for each patient.

    Secondary Outcome Measures

    1. change in office BP [baseline, 6 months, and 12 months]

      Difference in office blood pressure measurements at 6 months and at 12 months as compared to baseline.

    2. change in ambulatory BP [baseline and at 12 months]

      Difference in 24 hour ambulatory blood pressure measurements at 12 months compared to baseline

    3. Renal artery dimensions [baseline and at 6 months]

      Change in renal artery dimensions at 6 months.

    4. Creatinine [baseline and at 6 months]

      Differences in creatinine measurements recorded at baseline and at 6 months for each patient.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fakultní nemocnice u sv. Anny v Brně Brno Czech Republic 53, 656 91
    2 Na Homolce Hospital Prague Czech Republic 15030

    Sponsors and Collaborators

    • Vivek Reddy
    • Biosense Webster, Inc.

    Investigators

    • Principal Investigator: Vivek Reddy, MD, Icahn School of Medicine at Mount Sinai

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Vivek Reddy, Director Cardiac Arrhythmia Service, Professor of Medicine, Icahn School of Medicine at Mount Sinai
    ClinicalTrials.gov Identifier:
    NCT01628172
    Other Study ID Numbers:
    • GCO 11-0965
    First Posted:
    Jun 26, 2012
    Last Update Posted:
    Jun 29, 2016
    Last Verified:
    Jun 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Vivek Reddy, Director Cardiac Arrhythmia Service, Professor of Medicine, Icahn School of Medicine at Mount Sinai
    renal sympathetic denervation
    renal catheter ablation
    hypertension
    Additional relevant MeSH terms:
    Hypertension

    Study Results

    No Results Posted as of Jun 29, 2016