Renal Denervation in Patients With Uncontrolled Blood Pressure

• Sponsor: Medstar Health Research Institute (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01968785
• Collaborator: (none)
• Enrollment: 2
• Location: 1
• Arms: 2
• Actual Duration (Months): 41
• Patients Per Site Per Month: 0

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Blood Pressure	Radiation: Radiation Dose 25 Gy; Radiation: Radiation Dose 50 Gy	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 2 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: RENAL ARTERY IRRADIATION FOR SYMPATHETIC RENAL DENERVATION IN PATIENTS WITH RESISTANT HYPERTENSION
• Actual Study Start Date: Aug 1, 2013
• Actual Primary Completion Date: Jan 1, 2017
• Actual Study Completion Date: Jan 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. 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 [up to 6 months post procedure]

   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

2. 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. [up to 6 months post 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.

3. Angiographic [up to 6 months post procedure]

   The angiographic endpoint is defined as late loss at 6 months by offline quantitative coronary angiography (QCA)

Secondary Outcome Measures

1. Effects on Blood Pressure [up to 6 months post procedure]

   Short term effects of renal artery brachytherapy on blood pressure

2. Safety-renal Artery Dissection or Perforation Requiring Intervention, and Serious Groin Complications Specifically. [up to 24 months post procedure]

   Acute procedural safety; renal artery dissection or perforation requiring intervention, and serious groin complications specifically.

3. eGFR or New Stenosis [up to 6 months post procedure]

   Estimated glomerular filtration rate (eGFR) drop >25% or new renal artery stenosis > 60% confirmed by angiogram at six months following renal artery brachytherapy procedure.

4. Medication Changes [up to 24 months post procedure]

   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

5. Serious Adverse Events [up to 24 months post procedure]

   Rate of any serious adverse events or device-related adverse events

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

3. Main renal arteries with <20 mm treatable length

4. Renal artery stenosis of ≥20% by angiography.

5. A history of prior renal artery intervention including balloon angioplasty or stenting.

6. Multiple main renal arteries in either kidney.

7. Individual has an eGFR of < 45mL/min/1.73m2, using the MDRD formula calculation.

8. Individual has had >1 hospital admission for a hypertensive crisis within the past year.

9. Individual has an Ambulatory Blood Pressure Monitoring 24 hour average SBP<135mmHg.

10. 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.

11. Individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea.

12. Individual has primary pulmonary hypertension.

13. Individual has scheduled or planned surgery or cardiovascular intervention in the next 3 months.

14. 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).

15. Individual is pregnant, nursing or planning to be pregnant.

16. Individual has hemodynamically significant valvular heart disease for which reduction of blood pressure would be considered hazardous.

17. 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).

18. 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.

19. Individual is currently enrolled in another investigational drug or device trial.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	MedStar Washington Hospital Center	Washington	District of Columbia	United States	20010

Sponsors and Collaborators

• Medstar Health Research Institute

Investigators

• Principal Investigator: Ron Waksman, MD, Medstar Washington Hospital Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medstar Health Research Institute
• ClinicalTrials.gov Identifier: NCT01968785
• Other Study ID Numbers: Renal Denervation
• First Posted: Oct 24, 2013
• Last Update Posted: Jan 13, 2022
• Last Verified: Jan 1, 2022

Study Results

Participant Flow

Arm/Group Title	Radiation Dose 25 Gy	Radiation Dose 50 Gy
Arm/Group Description	• 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 Dose 25 Gy: Renal Denervation is performed using the Beta-Cath 3.5F to a deliver radiation dose 25 Gy to the renal artery.	• 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 Dose 50 Gy: Renal Denervation is performed using the Beta-Cath 3.5F to a deliver radiation dose 50 Gy to the renal artery.
Period Title: Overall Study
STARTED	2	0
COMPLETED	1	0
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	Radiation Dose 25 Gy	Radiation Dose 50 Gy	Total
Arm/Group Description	• 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 Dose 25 Gy: Renal Denervation is performed using the Beta-Cath 3.5F to a deliver radiation dose 25 Gy to the renal artery.	• 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 Dose 50 Gy: Renal Denervation is performed using the Beta-Cath 3.5F to a deliver radiation dose 50 Gy to the renal artery.	Total of all reporting groups
Overall Participants	2	0	2
Age (Count of Participants)
<=18 years	0 0%	0 NaN	0 0%
Between 18 and 65 years	1 50%	0 NaN	1 50%
>=65 years	1 50%	0 NaN	1 50%
Sex: Female, Male (Count of Participants)
Female	1 50%	0 NaN	1 50%
Male	1 50%	0 NaN	1 50%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 NaN	0 0%
Asian	0 0%	0 NaN	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 NaN	0 0%
Black or African American	1 50%	0 NaN	1 50%
White	1 50%	0 NaN	1 50%
More than one race	0 0%	0 NaN	0 0%
Unknown or Not Reported	0 0%	0 NaN	0 0%
Region of Enrollment (Count of Participants)
United States	2 100%	0 NaN	2 100%

Outcome Measures

1. Primary Outcome

Title	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
Description	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
Time Frame	up to 6 months post procedure

Outcome Measure Data

Analysis Population Description

Not enough patients were enrolled to be analyzed

Arm/Group Title	Radiation Dose 25 Gy	Radiation Dose 50 Gy
Arm/Group Description	• 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 Dose 25 Gy: Renal Denervation is performed using the Beta-Cath 3.5F to a deliver radiation dose 25 Gy to the renal artery.	• 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 Dose 50 Gy: Renal Denervation is performed using the Beta-Cath 3.5F to a deliver radiation dose 50 Gy to the renal artery.
Measure Participants	0	0

2. Primary Outcome

Title	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.
Description	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.
Time Frame	up to 6 months post procedure

Outcome Measure Data

Analysis Population Description

Not enough patients were enrolled to be analyzed

Arm/Group Title	Radiation Dose 25 Gy	Radiation Dose 50 Gy
Arm/Group Description	• 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 Dose 25 Gy: Renal Denervation is performed using the Beta-Cath 3.5F to a deliver radiation dose 25 Gy to the renal artery.	• 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 Dose 50 Gy: Renal Denervation is performed using the Beta-Cath 3.5F to a deliver radiation dose 50 Gy to the renal artery.
Measure Participants	0	0

3. Primary Outcome

Title	Angiographic
Description	The angiographic endpoint is defined as late loss at 6 months by offline quantitative coronary angiography (QCA)
Time Frame	up to 6 months post procedure

Outcome Measure Data

Analysis Population Description

not enough patients were enrolled to analize data

Arm/Group Title	Radiation Dose 25 Gy	Radiation Dose 50 Gy
Arm/Group Description	• 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 Dose 25 Gy: Renal Denervation is performed using the Beta-Cath 3.5F to a deliver radiation dose 25 Gy to the renal artery.	• 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 Dose 50 Gy: Renal Denervation is performed using the Beta-Cath 3.5F to a deliver radiation dose 50 Gy to the renal artery.
Measure Participants	0	0

4. Secondary Outcome

Title	Effects on Blood Pressure
Description	Short term effects of renal artery brachytherapy on blood pressure
Time Frame	up to 6 months post procedure

Outcome Measure Data

Analysis Population Description

Not enough patients were enrolled to be analyzed

Arm/Group Title	Radiation Dose 25 Gy	Radiation Dose 50 Gy
Arm/Group Description	• 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 Dose 25 Gy: Renal Denervation is performed using the Beta-Cath 3.5F to a deliver radiation dose 25 Gy to the renal artery.	• 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 Dose 50 Gy: Renal Denervation is performed using the Beta-Cath 3.5F to a deliver radiation dose 50 Gy to the renal artery.
Measure Participants	0	0

5. Secondary Outcome

Title	Safety-renal Artery Dissection or Perforation Requiring Intervention, and Serious Groin Complications Specifically.
Description	Acute procedural safety; renal artery dissection or perforation requiring intervention, and serious groin complications specifically.
Time Frame	up to 24 months post procedure

Outcome Measure Data

Analysis Population Description

Not enough patients were enrolled to be analyzed

Arm/Group Title	Radiation Dose 25 Gy	Radiation Dose 50 Gy
Arm/Group Description	• 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 Dose 25 Gy: Renal Denervation is performed using the Beta-Cath 3.5F to a deliver radiation dose 25 Gy to the renal artery.	• 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 Dose 50 Gy: Renal Denervation is performed using the Beta-Cath 3.5F to a deliver radiation dose 50 Gy to the renal artery.
Measure Participants	0	0

6. Secondary Outcome

Title	eGFR or New Stenosis
Description	Estimated glomerular filtration rate (eGFR) drop >25% or new renal artery stenosis > 60% confirmed by angiogram at six months following renal artery brachytherapy procedure.
Time Frame	up to 6 months post procedure

Outcome Measure Data

Analysis Population Description

Not enough patients were enrolled to be analyzed

Arm/Group Title	Radiation Dose 25 Gy	Radiation Dose 50 Gy
Arm/Group Description	• 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 Dose 25 Gy: Renal Denervation is performed using the Beta-Cath 3.5F to a deliver radiation dose 25 Gy to the renal artery.	• 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 Dose 50 Gy: Renal Denervation is performed using the Beta-Cath 3.5F to a deliver radiation dose 50 Gy to the renal artery.
Measure Participants	0	0

7. Secondary Outcome

Title	Medication Changes
Description	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
Time Frame	up to 24 months post procedure

Outcome Measure Data

Analysis Population Description

Not enough patients were enrolled to be analyzed

Arm/Group Title	Radiation Dose 25 Gy	Radiation Dose 50 Gy
Arm/Group Description	• 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 Dose 25 Gy: Renal Denervation is performed using the Beta-Cath 3.5F to a deliver radiation dose 25 Gy to the renal artery.	• 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 Dose 50 Gy: Renal Denervation is performed using the Beta-Cath 3.5F to a deliver radiation dose 50 Gy to the renal artery.
Measure Participants	0	0

8. Secondary Outcome

Title	Serious Adverse Events
Description	Rate of any serious adverse events or device-related adverse events
Time Frame	up to 24 months post procedure

Outcome Measure Data

Analysis Population Description

Not enough patients were enrolled to be analyzed

Arm/Group Title	Radiation Dose 25 Gy	Radiation Dose 50 Gy
Arm/Group Description	• 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 Dose 25 Gy: Renal Denervation is performed using the Beta-Cath 3.5F to a deliver radiation dose 25 Gy to the renal artery.	• 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 Dose 50 Gy: Renal Denervation is performed using the Beta-Cath 3.5F to a deliver radiation dose 50 Gy to the renal artery.
Measure Participants	0	0

Adverse Events

Time Frame	24 months
Adverse Event Reporting Description	Radiation Dose 50 Gy: No patients were enrolled in this arm of the study
Arm/Group Title	Radiation Dose 25 Gy		Radiation Dose 50 Gy
Arm/Group Description	• 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 Dose 25 Gy: Renal Denervation is performed using the Beta-Cath 3.5F to a deliver radiation dose 25 Gy to the renal artery.		• 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 Dose 50 Gy: Renal Denervation is performed using the Beta-Cath 3.5F to a deliver radiation dose 50 Gy to the renal artery.
All Cause Mortality
	Radiation Dose 25 Gy		Radiation Dose 50 Gy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/0 (NaN)
Serious Adverse Events
	Radiation Dose 25 Gy		Radiation Dose 50 Gy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Radiation Dose 25 Gy		Radiation Dose 50 Gy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/2 (50%)		0/0 (NaN)
Musculoskeletal and connective tissue disorders
Jaw Pain	1/2 (50%)	1	0/0 (NaN)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.