Resistant HypertensionPhase 3DEPARTNCT01522430
Study of Catheter Based Renal Denervation Therapy in Hypertension
A Phase 3 study testing Renal angiography followed by renal sympathetic denervation and Renal angiography alone in people with Resistant Hypertension and Renal Denervation, run by Erasme University Hospital at 1 site in Belgium.
Trial summary
The DEPART study end points are to provide conclusive evidence, using a randomized, double blinded, sham procedure controlled study design, that radiofrequency renal denervation: 1. reduces daytime ambulatory blood pressure, 2. improves nocturnal dipping in blood pressure at the ambulatory blood pressure recording. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Resistant Hypertension, Renal Denervation, Ambulatory Blood Pressure
- What is being tested?
- Renal angiography followed by renal sympathetic denervation and Renal angiography alone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2012to Dec 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- They have a mandatory > 3 antihypertensive medication therapy, including a thiazide or a loop diuretic (according to the patient's renal function, unless documented side-effects) and at least one attempt to treat with spironolactone, given at usual recommended dose since at least 8 weeks, before inclusion,
- A mandatory check list of secondary cause of hypertension has been excluded
- They succeed the pill count test.
- They have a mandatory ambulatory blood pressure monitoring before inclusion with at least 70% of valid readings during daytime (08:00 am 08:00 pm, using a sampling frequency of 20 minutes, only devices validated according to http://www.dableducational.org are permitted), where daytime ambulatory blood pressure of systolic and/or diastolic blood pressure exceeds 135 mmHg and/or 85 mmHg, respectively. Daytime ambulatory blood pressure of systolic and/or diastolic blood pressure below 135 mmHg and/or 85 mmHg, respectively, is acceptable for inclusion in the study if the patient takes four or more antihypertensive medication (3).
Who cannot join
- Patients with an eGFR <30ml/min/m² are excluded,
- patients with known renal atherosclerotic lesions,
- previous procedures in the renal arteries,
- known unsuitable anatomy for the procedure,
- previous nephrectomy,
- contrast agent allergy,
- hyperthyroidia.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Erasme Hospital
Brussels, 1070
Jean Francois ARGACHA, MD, 3225555214, Jean.Francois.Argacha@erasme.ulb.ac.be
About this study
Official title: DENERVATION OF RENAL SYMPATHETIC ACTIVITY AND HYPERTENSION STUDY
The DEPART study end points are to provide conclusive evidence, using a randomized, double blinded, sham procedure controlled study design, that radiofrequency renal denervation:
- reduces daytime ambulatory blood pressure,
- improves nocturnal dipping in blood pressure at the ambulatory blood pressure recording.
- Being tested
- Renal angiography followed by renal sympathetic denervation, Renal angiography alone
- Keywords
- Resistant hypertension, Renal denervation, Ambulatory blood pressure, Renal function, Simplicity catheter, Sham procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal angiography followed by renal sympathetic denervationProcedure or surgery
Radiofrequency catheter based therapy for renal denervation: Symplicity catheter will be advanced into the renal artery and connected to a radiofrequency generator. As previously described, four-to-six discrete, low-power radio frequency treatments will be applied along the length of both main renal arteries. At least four radiofrequency applications will be delivered in each renal artery, unless this is not feasible for anatomical reasons.
Renal angiography aloneProcedure or surgery
Procedure will start with a local anesthesia of the femoral site to allow the placement of a 4-Fr sheath in the femoral artery, which allows a minimal risk of bleeding to the patient. Using JR-4 or similar diagnostic catheter, a selective renal angiography will be realized.
| Study group | Role | What they receive |
|---|---|---|
| Renal angiography followed by renal sympathetic denervation | Experimental | Catheter based therapy for renal denervation using the Simplicity (TM) catheter (Ardian/Medtronic) Receives: Procedure: Renal angiography followed by renal sympathetic denervation |
| Renal angiography alone | Sham comparator | Renal selective angiography using standardized method: Local anesthesia of the femoral site to allow the placement of a 4-Fr sheath in the femoral artery. Using JR-4 or similar diagnostic catheter, a selective renal angiography will be realized. Receives: Procedure: Renal angiography alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
glomerular filtration rate
Isotopic and 24h urine sample measure of glomerular filtration rate.
Measured: 6 month
Ambulatory systolic and diastolic blood pressure
Ambulatory systolic and diastolic blood pressure measured on 24h ABPM device
Measured: 6 month
Secondary outcomes (2)
Baroreflex sensitivity
Migroneugraphy recording of sympathetic nerve activity and testing of baroreflex sensitivity
Measured: 6 month
Biological markers of acute kidney injury
Urine sample for NGAL, L-FABP and Cystatine C at baseline, H2, H6, 1, 3 and 6 months
Measured: baseline, H2, H6, 1, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionDec 2014 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resistant HypertensionStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean Francois Argacha, Erasme University Hospital
- Investigators
- Jean-François ARGACHA, MD, Principal investigator, Erasme University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01522430
- Sponsor's protocol ID
- 140576
- Acronym
- DEPART
- Status last verified
- Jan 2012
- First submitted
- 25 Jan 2012
- Last updated
- 31 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DENERVATION OF RENAL SYMPATHETIC ACTIVITY AND HYPERTENSION STUDY
- ClinicalTrials.gov ID
- NCT01522430
- Acronym / sponsor ID
- DEPART / 140576
- Keywords
- Resistant hypertension, Renal denervation, Ambulatory blood pressure, Renal function, Simplicity catheter, Sham procedure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 31 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The DEPART study end points are to provide conclusive evidence, using a randomized, double blinded, sham procedure controlled study design, that radiofrequency renal denervation:
- reduces daytime ambulatory blood pressure,
- improves nocturnal dipping in blood pressure at the ambulatory blood pressure recording.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Renal angiography followed by renal sympathetic denervation | Experimental | Procedure: Renal angiography followed by renal sympathetic denervationCatheter based therapy for renal denervation using the Simplicity (TM) catheter (Ardian/Medtronic) |
| Renal angiography alone | Sham comparator | Procedure: Renal angiography aloneRenal selective angiography using standardized method: Local anesthesia of the femoral site to allow the placement of a 4-Fr sheath in the femoral artery. Using JR-4 or similar diagnostic catheter, a selective renal angiography will be realized. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- They have a mandatory > 3 antihypertensive medication therapy, including a thiazide or a loop diuretic (according to the patient's renal function, unless documented side-effects) and at least one attempt to treat with spironolactone, given at usual recommended dose since at least 8 weeks, before inclusion,
- A mandatory check list of secondary cause of hypertension has been excluded
- They succeed the pill count test.
- They have a mandatory ambulatory blood pressure monitoring before inclusion with at least 70% of valid readings during daytime (08:00 am 08:00 pm, using a sampling frequency of 20 minutes, only devices validated according to http://www.dableducational.org are permitted), where daytime ambulatory blood pressure of systolic and/or diastolic blood pressure exceeds 135 mmHg and/or 85 mmHg, respectively. Daytime ambulatory blood pressure of systolic and/or diastolic blood pressure below 135 mmHg and/or 85 mmHg, respectively, is acceptable for inclusion in the study if the patient takes four or more antihypertensive medication (3).
Key exclusion criteria (7 listed)
- Patients with an eGFR <30ml/min/m² are excluded,
- patients with known renal atherosclerotic lesions,
- previous procedures in the renal arteries,
- known unsuitable anatomy for the procedure,
- previous nephrectomy,
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 |
|---|---|---|
| Renal angiography followed by renal sympathetic denervationRadiofrequency catheter based therapy for renal denervation: Symplicity catheter will be advanced into the renal artery and connected to a radiofrequency generator. As previously described, four-to-six discrete, low-power radio frequency treatments will be applied along the length of both main renal arteries. At least four radiofrequency applications will be delivered in each renal artery, unless this is not feasible for anatomical reasons. | Procedure or surgery | Renal angiography followed by renal sympathetic denervation |
| Renal angiography aloneProcedure will start with a local anesthesia of the femoral site to allow the placement of a 4-Fr sheath in the femoral artery, which allows a minimal risk of bleeding to the patient. Using JR-4 or similar diagnostic catheter, a selective renal angiography will be realized. | Procedure or surgery | Renal angiography alone |
Primary outcome
glomerular filtration rate
Time frame: 6 month
Isotopic and 24h urine sample measure of glomerular filtration rate.
Ambulatory systolic and diastolic blood pressure
Time frame: 6 month
Ambulatory systolic and diastolic blood pressure measured on 24h ABPM device
2 secondary outcomes
Baroreflex sensitivity
Time frame: 6 month
Biological markers of acute kidney injury
Time frame: baseline, H2, H6, 1, 3 and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2012.
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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.
Jean-François ARGACHA, MD principal investigator
Erasme University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Renal angiography followed by renal sympathetic denervation and Renal angiography alone in people with Resistant Hypertension and Renal Denervation, run by Erasme University Hospital at 1 site in Belgium.
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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 31 Jan 2012. 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 Belgium. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ARGACHA Jean francois, MD (33225555214, Jean.Francois.Argacha@erasme.ulb.ac.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
glomerular filtration rate (time frame: 6 month). The study lists 2 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 31 Jan 2012.