Blood Pressure
Conditions
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.
Interventions
RADIATIONRadiation Dose 25 Gy
Renal Denervation is performed using the Beta-Cath 3.5F to a deliver radiation dose 25 Gy to the renal artery.
RADIATIONRadiation Dose 50 Gy
Renal Denervation is performed using the Beta-Cath 3.5F to a deliver radiation dose 50 Gy to the renal artery.
Sponsors
Medstar Health Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
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: 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| Medication Changes | up to 24 months post procedure | Any changes made in the patients' blood pressure medication regimen throughout the 24 month duration. Specifically, 1. Additions, changes and cessation of medications 2. Dosage changes throughout the follow up duration |
| Effects on Blood Pressure | up to 6 months post procedure | Short term effects of renal artery brachytherapy on blood pressure |
| Serious Adverse Events | up to 24 months post procedure | Rate of any serious adverse events or device-related adverse events |
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 Dose 25 Gy: Renal Denervation is performed using the Beta-Cath 3.5F to a deliver radiation dose 25 Gy to the renal artery. | 2 |
| 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 Dose 50 Gy: Renal Denervation is performed using the Beta-Cath 3.5F to a deliver radiation dose 50 Gy to the renal artery. | 0 |
| Total | 2 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Radiation Dose 25 Gy | Radiation Dose 50 Gy | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 0 Participants | 1 Participants |
| Region of Enrollment United States | 2 Participants | 0 Participants | 2 Participants |
| Sex: Female, Male Female | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Male | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 0 |
| other Total, other adverse events | 1 / 2 | 0 / 0 |
| serious Total, serious adverse events | 0 / 2 | 0 / 0 |
Outcome results
Primary
Angiographic
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
Population: not enough patients were enrolled to analize data
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.
Time frame: up to 6 months post procedure
Population: Not enough patients were enrolled to be analyzed
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
Time frame: up to 6 months post procedure
Population: Not enough patients were enrolled to be analyzed
Secondary
Effects on Blood Pressure
Short term effects of renal artery brachytherapy on blood pressure
Time frame: up to 6 months post procedure
Population: Not enough patients were enrolled to be analyzed
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.
Time frame: up to 6 months post procedure
Population: Not enough patients were enrolled to be analyzed
Secondary
Medication Changes
Any changes made in the patients' blood pressure medication regimen throughout the 24 month duration. Specifically, 1. Additions, changes and cessation of medications 2. Dosage changes throughout the follow up duration
Time frame: up to 24 months post procedure
Population: Not enough patients were enrolled to be analyzed
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.
Time frame: up to 24 months post procedure
Population: Not enough patients were enrolled to be analyzed
Secondary
Serious Adverse Events
Rate of any serious adverse events or device-related adverse events
Time frame: up to 24 months post procedure
Population: Not enough patients were enrolled to be analyzed