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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
  Purpose

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.

Condition Intervention
Blood Pressure
Radiation: Radiation Dose 25 Gy
Radiation: Radiation Dose 50 Gy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: RENAL ARTERY IRRADIATION FOR SYMPATHETIC RENAL DENERVATION IN PATIENTS WITH RESISTANT HYPERTENSION

Resource links provided by NLM:


Further study details as provided by Medstar Research Institute:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 20
Study Start Date: August 2013
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.
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.

  Eligibility

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

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.
  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: NCT01968785

Contacts
Contact: Ron Waksman, MD 202-877-5975 ron.waksman@medstar.net

Locations
United States, District of Columbia
MedStar Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Ron Waksman, MD    202-877-5975    ron.waksman@medstar.net   
Contact: Suman Singh    202-877-8475    suman.singh@medstar.net   
Principal Investigator: Ron Waksman, MD         
Sponsors and Collaborators
Medstar Research Institute
Investigators
Principal Investigator: Ron Waksman, MD Medstar Washington Hospital Center
  More Information

No publications provided

Responsible Party: Medstar Research Institute
ClinicalTrials.gov Identifier: NCT01968785     History of Changes
Other Study ID Numbers: Renal Denervation
Study First Received: October 16, 2013
Last Updated: August 8, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on November 23, 2014