Clinical trial NCT01968785: Renal Denervation in Patients With Uncontrolled Blood Pressure
Official title: RENAL ARTERY IRRADIATION FOR SYMPATHETIC RENAL DENERVATION IN PATIENTS WITH RESISTANT HYPERTENSION
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Blood Pressure
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
First posted: 2013-10-24
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Safety-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
timeFrame: up to 6 months post procedure
measure: Efficacy- Renal Artery Brachytherapy With Beta-emitting Source is Decrease in Systolic and Diastolic Blood Pressure of ≥10 mmHg at Six Months Following the Procedure.
timeFrame: up to 6 months post procedure
measure: Angiographic
timeFrame: up to 6 months post procedure
Secondary outcomes:
measure: Effects on Blood Pressure
timeFrame: up to 6 months post procedure
measure: Safety-renal Artery Dissection or Perforation Requiring Intervention, and Serious Groin Complications Specifically.
timeFrame: up to 24 months post procedure
measure: eGFR or New Stenosis
timeFrame: up to 6 months post procedure
measure: Medication Changes
timeFrame: up to 24 months post procedure
measure: Serious Adverse Events
timeFrame: up to 24 months post procedure
Other outcomes:
Locations:
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
Study officials:
affiliation: Medstar Health Research Institute
name: Ron Waksman, MD
role: PRINCIPAL_INVESTIGATOR
References: