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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

June 12, 2012
March 24, 2014
January 2011
September 2014   (final data collection date for primary outcome measure)
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.
Change in24-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.
Complete list of historical versions of study NCT01628172 on ClinicalTrials.gov Archive Site
  • 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.
  • office BP [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
    Difference in office blood pressure measurements
  • ambulatory BP [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
    Difference in 24 hour ambulatory blood pressure measurements
  • 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.
Not Provided
Not Provided
 
Renal Sympathetic Denervation for the Management of Chronic Hypertension
Renal Sympathetic Denervation for the Management of Chronic Hypertension

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Uncontrolled Hypertension
Device: Biosense Webster Celcius Thermacool catheter
catheter-based sympathetic renal denervation
Other Names:
  • sympathetic renal denervation
  • Ablation arm
  • Experimental: Biosense Webster Celcius Thermacool catheter
    These subjects will undergo catheter-based sympathetic renal denervation. Ablation arm
    Intervention: Device: Biosense Webster Celcius Thermacool catheter
  • No Intervention: renal angiogram only
    Control Group: Control arm will not receive intervention but will be followed for 1 year.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
100
January 2015
September 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic
 
NCT01628172
GCO 11-0965
Yes
Vivek Reddy, Mount Sinai School of Medicine
Vivek Reddy
Biosense Webster, Inc.
Principal Investigator: Vivek Reddy, MD Mount Sinai School of Medicine
Mount Sinai School of Medicine
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP