Blood PressureNCT01968785
Renal Denervation in Patients With Uncontrolled Blood Pressure
A study testing Radiation Dose 25 Gy and Radiation Dose 50 Gy in people with Blood Pressure, run by Medstar Health Research Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Blood Pressure
- What is being tested?
- Radiation Dose 25 Gy and Radiation Dose 50 Gy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Jan 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 4.2.1 GENERAL INCLUSION CRITERIA
- Subjects must meet all of the following inclusion criteria prior to enrollment into the trial:
- 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.
- 4.2.2 ANGIOGRAPHIC INCLUSION CRITERIA
- 1. Individual has main renal arteries measuring <2.75 mm in diameter.
Who cannot join
- 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.
Show all 19Show fewer
- 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.
- Individual has hemodynamically significant valvular heart disease for which reduction of blood pressure would be considered hazardous.
- 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).
- 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.
- Individual is currently enrolled in another investigational drug or device trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: RENAL ARTERY IRRADIATION FOR SYMPATHETIC RENAL DENERVATION IN PATIENTS WITH RESISTANT HYPERTENSION
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.
- Renal artery brachytherapy with beta-emitting source is safe.
- 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
- Being tested
- Radiation Dose 25 Gy, Radiation Dose 50 Gy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation Dose 25 GyRadiation
Renal Denervation is performed using the Beta-Cath 3.5F to a deliver radiation dose 25 Gy to the renal artery.
Radiation Dose 50 GyRadiation
Renal Denervation is performed using the Beta-Cath 3.5F to a deliver radiation dose 50 Gy to the renal artery.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Radiation: Radiation Dose 50 Gy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: up to 6 months post procedure
Angiographic
The angiographic endpoint is defined as late loss at 6 months by offline quantitative coronary angiography (QCA)
Measured: up to 6 months post procedure
Secondary outcomes (5)
Effects on Blood Pressure
Short term effects of renal artery brachytherapy on blood pressure
Measured: up to 6 months post procedure
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.
Measured: up to 24 months post procedure
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.
Measured: up to 6 months post procedure
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
Measured: up to 24 months post procedure
Serious Adverse Events
Rate of any serious adverse events or device-related adverse events
Measured: up to 24 months post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2013 (estimated)
- Study startAug 2013
- Primary completionJan 2017
- Study completionJan 2017
Why it stopped: Low Enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ron Waksman, MD, Principal investigator, Medstar Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01968785
- Sponsor's protocol ID
- Renal Denervation
- Status last verified
- Jan 2022
- First submitted
- 16 Oct 2013
- Last updated
- 13 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RENAL ARTERY IRRADIATION FOR SYMPATHETIC RENAL DENERVATION IN PATIENTS WITH RESISTANT HYPERTENSION
- ClinicalTrials.gov ID
- NCT01968785
- Acronym / sponsor ID
- Renal Denervation
- Conditions
- Blood Pressure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low Enrollment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Study start
- Aug 2013 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 24 Oct 2013 (estimated)
- Results
- Posted 13 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- Renal artery brachytherapy with beta-emitting source is safe.
- Renal artery brachytherapy with beta-emitting source can reduce systolic/diastolic blood pressure via renal denervation mechanism within 6 months post treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiation dose 25 Gy | Active comparator | Radiation: 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 50 Gy | Active comparator | Radiation: 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 4.2.1 GENERAL INCLUSION CRITERIA
- Subjects must meet all of the following inclusion criteria prior to enrollment into the trial:
- 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.
Key exclusion criteria (19 listed)
- Inability to sign written informed consent.
- Individual has renal artery anatomy that is ineligible for treatment including:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiation Dose 25 GyRenal Denervation is performed using the Beta-Cath 3.5F to a deliver radiation dose 25 Gy to the renal artery. | Radiation | Radiation dose 25 Gy |
| Radiation Dose 50 GyRenal Denervation is performed using the Beta-Cath 3.5F to a deliver radiation dose 50 Gy to the renal artery. | Radiation | Radiation dose 50 Gy |
Primary outcome
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
Time frame: 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.
Time frame: 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
Time frame: up to 6 months post procedure
The angiographic endpoint is defined as late loss at 6 months by offline quantitative coronary angiography (QCA)
5 secondary outcomes
Effects on Blood Pressure
Time frame: up to 6 months post procedure
Safety-renal Artery Dissection or Perforation Requiring Intervention, and Serious Groin Complications Specifically.
Time frame: up to 24 months post procedure
eGFR or New Stenosis
Time frame: up to 6 months post procedure
Medication Changes
Time frame: up to 24 months post procedure
Serious Adverse Events
Time frame: up to 24 months post procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ron Waksman, MD principal investigator
Medstar Health Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiation Dose 25 Gy and Radiation Dose 50 Gy in people with Blood Pressure, run by Medstar Health Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: up to 6 months post procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2022.