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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Biosense Webster, Inc.
Information provided by (Responsible Party):
Vivek Reddy, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01628172
First received: June 12, 2012
Last updated: March 24, 2014
Last verified: March 2014
  Purpose

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 Intervention
Uncontrolled Hypertension
Device: Biosense Webster Celcius Thermacool catheter

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Renal Sympathetic Denervation for the Management of Chronic Hypertension

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • Change in 24-hour ambulatory BP [ Time Frame: baseline and at 6 months ] [ Designated as safety issue: No ]
    Differences in 24-hour ambulatory blood pressure measurements recorded at baseline and at 6 months for each patient.


Secondary Outcome Measures:
  • change in office BP [ Time Frame: baseline, 6 months, and 12 months ] [ Designated as safety issue: No ]
    Difference in office blood pressure measurements at 6 months and at 12 months as compared to baseline.

  • change in ambulatory BP [ Time Frame: baseline and at 12 months ] [ Designated as safety issue: No ]
    Difference in 24 hour ambulatory blood pressure measurements at 12 months compared to baseline

  • Renal artery dimensions [ Time Frame: baseline and at 6 months ] [ Designated as safety issue: No ]
    Change in renal artery dimensions at 6 months.

  • Creatinine [ Time Frame: baseline and at 6 months ] [ Designated as safety issue: No ]
    Differences in creatinine measurements recorded at baseline and at 6 months for each patient.


Estimated Enrollment: 100
Study Start Date: January 2011
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01628172

Locations
Czech Republic
Fakultní nemocnice u sv. Anny v Brně
Brno, Czech Republic, 53, 656 91
Na Homolce Hospital
Prague, Czech Republic, 15030
Sponsors and Collaborators
Vivek Reddy
Biosense Webster, Inc.
Investigators
Principal Investigator: Vivek Reddy, MD Mount Sinai School of Medicine
  More Information

Publications:

Responsible Party: Vivek Reddy, Director Cardiac Arrhythmia Service, Professor of Medicine, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT01628172     History of Changes
Other Study ID Numbers: GCO 11-0965
Study First Received: June 12, 2012
Last Updated: March 24, 2014
Health Authority: United States: Institutional Review Board
Europe: Ethic Committee, Na Homolce Hospital

Keywords provided by Mount Sinai School of Medicine:
renal sympathetic denervation
renal catheter ablation
hypertension

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 22, 2014