Renal Denervation in Patients With Uncontrolled Blood Pressure

NCT ID: NCT01968785

Last Updated: 2022-01-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2017-01-31

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.

Conditions

Blood Pressure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Radiation Dose 25 Gy

Intervention Type: RADIATION

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

• 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.

Group Type: ACTIVE_COMPARATOR

Radiation Dose 50 Gy

Intervention Type: RADIATION

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

Interventions

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.

Intervention Type: 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.

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medstar Health Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ron Waksman, MD

Role: PRINCIPAL_INVESTIGATOR

Medstar Health Research Institute

Locations

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

Countries

United States

Other Identifiers

Renal Denervation

Identifier Type: -

Identifier Source: org_study_id