Renal Denervation in Patients With Uncontrolled Blood Pressure

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Medstar Research Institute
Sponsor:
Information provided by (Responsible Party):
Medstar Research Institute
ClinicalTrials.gov Identifier:
NCT01968785
First received: October 16, 2013
Last updated: August 8, 2014
Last verified: August 2014

October 16, 2013
August 8, 2014
August 2013
December 2015   (final data collection date for primary outcome measure)
  • Safety [ Time Frame: up to 6 months post procedure ] [ Designated as safety issue: Yes ]
    The primary safety endpoint for renal artery brachytherapy with beta-emitting source is any need for renal artery intervention to treat renal artery injury induced by the catheter of radiation within 6 months
  • Efficacy [ Time Frame: up to 6 months post procedure ] [ Designated as safety issue: No ]
    The primary efficacy endpoint for renal artery brachytherapy with beta-emitting source is decrease in systolic and diastolic blood pressure of ≥10 mmHg at six months following the procedure.
  • Angiographic [ Time Frame: up to 6 months post procedure ] [ Designated as safety issue: No ]
    The angiographic endpoint is defined as late loss at 6 months by offline quantitative coronary angiography (QCA)
Same as current
Complete list of historical versions of study NCT01968785 on ClinicalTrials.gov Archive Site
  • Effects on Blood Pressure [ Time Frame: up to 6 months post procedure ] [ Designated as safety issue: No ]
    Short term effects of renal artery brachytherapy on blood pressure
  • Safety [ Time Frame: up to 24 months post procedure ] [ Designated as safety issue: Yes ]
    Acute procedural safety; renal artery dissection or perforation requiring intervention, and serious groin complications specifically.
  • eGFR or New Stenosis [ Time Frame: up to 6 months post procedure ] [ Designated as safety issue: No ]
    Estimated glomerular filtration rate (eGFR) drop >25% or new renal artery stenosis > 60% confirmed by angiogram at six months following renal artery brachytherapy procedure.
  • Medication changes [ Time Frame: up to 24 months post procedure ] [ Designated as safety issue: No ]

    Any changes made in the patients' blood pressure medication regimen throughout the 24 month duration. Specifically,

    1. Additions, changes and cessation of medications
    2. Dosage changes throughout the follow up duration
  • Serious Adverse Events [ Time Frame: up to 24 months post procedure ] [ Designated as safety issue: Yes ]
    Rate of any serious adverse events or device-related adverse events
Same as current
Not Provided
Not Provided
 
Renal Denervation in Patients With Uncontrolled Blood Pressure
RENAL ARTERY IRRADIATION FOR SYMPATHETIC RENAL DENERVATION IN PATIENTS WITH RESISTANT HYPERTENSION

The kidneys are an important regulator of blood pressure. Previous research has shown that disrupting the nerves (denervate) of the kidney may successfully decrease blood pressure. In the past, one technique that was used to treat severe high blood pressure was a surgical procedure to cut these nerves. However, this surgery is no longer commonly performed.

Another approach to disrupting these nerves is to use the Beta-Cath 3.5F system to deliver a small amount of radiation to the treatment zone. The Beta-Cath 3.5F System (Novoste) is currently approved in the United States to deliver ion dose therapy to re-narrowings that form in the coronary arteries in the heart. This trial is assessing the safety of treating patients with the Beta-Cath 3.5F System (Novoste) to denervate the nerves around the kidney to help control blood pressure in patients with uncontrolled hypertension.

  1. Renal artery brachytherapy with beta-emitting source is safe.
  2. Renal artery brachytherapy with beta-emitting source can reduce systolic/diastolic blood pressure via renal denervation mechanism within 6 months post treatment.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Blood Pressure
  • Radiation: Radiation Dose 25 Gy
    Renal Denervation is performed using the Beta-Cath 3.5F to a deliver radiation dose 25 Gy to the renal artery.
  • Radiation: Radiation Dose 50 Gy
    Renal Denervation is performed using the Beta-Cath 3.5F to a deliver radiation dose 50 Gy to the renal artery.
  • Active Comparator: Radiation dose 25 Gy
    • 25 Gy: Subjects will be treated with beta radiation dosage of 25 Gy during renal denervation procedure. Subjects are to maintain baseline anti-hypertensive medications and will undergo follow-up for 24 months.
    Intervention: Radiation: Radiation Dose 25 Gy
  • Active Comparator: Radiation dose 50 Gy
    • 50 Gy: Subjects will be treated with beta radiation dosage of 50 Gy during renal denervation procedure. Subjects are to maintain baseline anti-hypertensive medications and will undergo follow-up for 24 months.
    Intervention: Radiation: Radiation Dose 50 Gy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
Not Provided
December 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 4.2.1 GENERAL INCLUSION CRITERIA

Subjects must meet all of the following inclusion criteria prior to enrollment into the trial:

  1. Individual is ≥ 18 and ≤ 85 years of age.
  2. Individual has a systolic blood pressure (SBP) ≥ 160 mmHg (≥ 150 mmHg for type 2 diabetics) based on an average of 3 office blood pressure readings.
  3. Individual is adhering to a stable (maximally tolerated dose) drug regimen including 3 or more anti-hypertensive medications for at least 1 month (including one diuretic) that is expected to be maintained for at least 6 months.
  4. Individual is competent and willing to provide informed consent to participate in the trial.

4.2.2 ANGIOGRAPHIC INCLUSION CRITERIA

1. Individual has main renal arteries measuring <2.75 mm in diameter.

Exclusion Criteria:

  1. Inability to sign written informed consent.
  2. Individual has renal artery anatomy that is ineligible for treatment including:

    1. Main renal arteries with <20 mm treatable length
    2. Renal artery stenosis of ≥20% by angiography.
    3. A history of prior renal artery intervention including balloon angioplasty or stenting.
    4. Multiple main renal arteries in either kidney.
  3. Individual has an eGFR of < 45mL/min/1.73m2, using the MDRD formula calculation.
  4. Individual has had >1 hospital admission for a hypertensive crisis within the past year.
  5. Individual has an Ambulatory Blood Pressure Monitoring 24 hour average SBP<135mmHg.
  6. Individual has has > 1 episode(s) of orthostatic hypotension (reduction of SBP of >20 mmHg or diastolic blood pressure (DBP) of >10 mmHg within 3 minutes of standing) coupled with symptoms within the past year or during the screening process.
  7. Individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea.
  8. Individual has primary pulmonary hypertension.
  9. Individual has scheduled or planned surgery or cardiovascular intervention in the next 3 months.
  10. Individual has a condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement using the protocol-specified automatic blood pressure monitor (e.g., arm diameter too large for the cuff, arrhythmia that interferes with automatic monitor's pulse sensing and prohibits an accurate measurement).
  11. Individual is pregnant, nursing or planning to be pregnant.
  12. Individual has hemodynamically significant valvular heart disease for which reduction of blood pressure would be considered hazardous.
  13. Individual has any serious medical condition, which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant or the study (i.e., patients with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, hemophilia, or significant anemia, or arrhythmias such as atrial fibrillation).
  14. Individual has a known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or would be unlikely or unable to comply with study follow-up requirements.
  15. Individual is currently enrolled in another investigational drug or device trial.
Both
18 Years to 85 Years
No
Contact: Ron Waksman, MD 202-877-5975 ron.waksman@medstar.net
United States
 
NCT01968785
Renal Denervation
No
Medstar Research Institute
Medstar Research Institute
Not Provided
Principal Investigator: Ron Waksman, MD Medstar Washington Hospital Center
Medstar Research Institute
August 2014

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