Renal Denervation in Patients With Uncontrolled Blood Pressure

Blood Pressure Clinical Trial

Official title:

RENAL ARTERY IRRADIATION FOR SYMPATHETIC RENAL DENERVATION IN PATIENTS WITH RESISTANT HYPERTENSION

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01968785
• Other study ID #: Renal Denervation
• Status: Terminated
• Phase: N/A
• Start date: August 2013
• Est. completion date: January 2017

Study information

• Verified date: January 2022
• Source: Medstar Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Blood Pressure

Intervention

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 Dose 50 Gy
Renal Denervation is performed using the Beta-Cath 3.5F to a deliver radiation dose 50 Gy to the renal artery.

Locations

Country	Name	City	State
United States	MedStar Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Medstar Health Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	up to 6 months post procedure
Primary	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.	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.	up to 6 months post procedure
Primary	Angiographic	The angiographic endpoint is defined as late loss at 6 months by offline quantitative coronary angiography (QCA)	up to 6 months post procedure
Secondary	Effects on Blood Pressure	Short term effects of renal artery brachytherapy on blood pressure	up to 6 months post procedure
Secondary	Safety-renal Artery Dissection or Perforation Requiring Intervention, and Serious Groin Complications Specifically.	Acute procedural safety; renal artery dissection or perforation requiring intervention, and serious groin complications specifically.	up to 24 months post procedure
Secondary	eGFR or New Stenosis	Estimated glomerular filtration rate (eGFR) drop >25% or new renal artery stenosis > 60% confirmed by angiogram at six months following renal artery brachytherapy procedure.	up to 6 months post procedure
Secondary	Medication Changes	Any changes made in the patients' blood pressure medication regimen throughout the 24 month duration. Specifically,; Additions, changes and cessation of medications; Dosage changes throughout the follow up duration	up to 24 months post procedure
Secondary	Serious Adverse Events	Rate of any serious adverse events or device-related adverse events	up to 24 months post procedure