Renal Denervation in Patients With Uncontrolled Blood Pressure

NCT01968785 | Terminated Results

• 1 other identifier: Renal Denervation
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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. 1.Renal artery brachytherapy with beta-emitting source is safe.
2. 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

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (5)

• Effects on Blood Pressure

  up to 6 months post procedure

• Safety-renal Artery Dissection or Perforation Requiring Intervention, and Serious Groin Complications Specifically.

  up to 24 months post procedure

• eGFR or New Stenosis

  up to 6 months post procedure

• Medication Changes

  up to 24 months post procedure

• Serious Adverse Events

  up to 24 months post procedure

Study Arms (2)

Radiation dose 25 Gy

ACTIVE COMPARATOR

• 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

Radiation dose 50 Gy

ACTIVE COMPARATOR

• 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

Interventions

Radiation Dose 25 Gy RADIATION

Renal Denervation is performed using the Beta-Cath 3.5F to a deliver radiation dose 25 Gy to the renal artery.

Radiation dose 25 Gy

Radiation Dose 50 Gy RADIATION

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

Radiation dose 50 Gy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individual is ≥ 18 and ≤ 85 years of age.
• 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.
• 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.
• Individual is competent and willing to provide informed consent to participate in the trial.
• \. Individual has main renal arteries measuring \<2.75 mm in diameter.

You may not qualify if:

• Inability to sign written informed consent.
• Individual has renal artery anatomy that is ineligible for treatment including:
• Main renal arteries with \<20 mm treatable length
• Renal artery stenosis of ≥20% by angiography.
• A history of prior renal artery intervention including balloon angioplasty or stenting.
• Multiple main renal arteries in either kidney.
• Individual has an eGFR of \< 45mL/min/1.73m2, using the MDRD formula calculation.
• Individual has had \>1 hospital admission for a hypertensive crisis within the past year.
• Individual has an Ambulatory Blood Pressure Monitoring 24 hour average SBP\<135mmHg.
• 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.
• Individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea.
• Individual has primary pulmonary hypertension.
• Individual has scheduled or planned surgery or cardiovascular intervention in the next 3 months.
• 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).
• Individual is pregnant, nursing or planning to be pregnant.

Sponsors & Collaborators

• Medstar Health Research Institute: lead

Study Sites (1)

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Results Point of Contact

• Title: Megan Rowland
• Organization: Medstar Health Research Institute

megan.e.rowland@medstar.net

2028772959

Study Officials

• Ron Waksman, MD

  Medstar Health Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2013
• First Posted: October 24, 2013
• Study Start: August 1, 2013
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: January 13, 2022
• Results First Posted: January 13, 2022

Record last verified: 2022-01

Locations

US (1)