Hypertension (HTN)FRIENDNCT07206030
Real Life Data From Hypertensive Patients Treated With Renal Denervation in Current Practice in France- French RENal Denervation Registry
An observational study of Hypertension (HTN), run by University Hospital, Grenoble at 1 site in France.
Trial summary
Renal denervation (RDN) is a recent procedure that can be used to control BP (blood pressure) in hypertensive patients. Numerous publications from randomised trials have demonstrated the efficacy of RDN in this indication. The latest guidelines now include RDN as an effective technique for use in hypertension. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension (HTN)
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 23 Jun 2025to Oct 2028
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a confirmed diagnosis of high blood pressure, eligible for a renal denervation
Who may be able to join
- Adult ( > 18 years old) hypertensive patients treated with RDN in France whatever the catheter and the indication. This might include retrospective data for patient already treated with RDN in the past.
Who cannot join
- RDN not proposed to the patient, patient opposing the collection and use of his/her data for research purposes.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Chu Grenoble Alpes
La Tronche, France, 38700
Olivier ORMEZZANO, Doctor of medicine, +33476768888, oormezzano@chu-grenoble.fr
Delphine POLLET, Master, +33476768823, dpollet@chu-grenoble.fr
About this study
Official title: FRiEND Registry: Real Life Data From Hypertensive Patients Treated With Renal Denervation in Current Practice in France- French RENal Denervation Registry
Renal denervation (RDN) is a recent procedure that can be used to control BP (blood pressure) in hypertensive patients. Numerous publications from randomised trials have demonstrated the efficacy of RDN in this indication. The latest guidelines now include RDN as an effective technique for use in hypertension. Since early 2023, RDN using Medtronic's Spiral radiofrequency system has benefited from transitional authorisation for reimbursement by the French health insurance system. An application for reimbursement is underway for the ultrasound system. We aim to compile an exhaustive prospective register of all procedures carried out in France over the next few years, regardless of the type of catheter used or the context in which the procedure was carried out (transitional reimbursement, industrial register, randomised trial). Our aim is to assess the efficacy and safety of the procedure within the French healthcare system, the characteristics of patients benefiting from the procedure, the centres performing renal denervation, and the care pathways used, and to be able to present all this data, independently of the industry, to the healthcare authorities when it comes time to reassess the value of this procedure and its indications. The goal of this observational study is to learn about changes in blood pressure in patient with high blood pressure before and 1 year after a renal denervation treatment (RDN).
The primary endpoint is to describe changes in systolic blood pressure (SBP) measured by Home Blood Pressure Measurement (HBPM) in patients suffering from high blood pressure, before and 1 year after RDN.
Read the detailed description
This study concerns patients with high blood pressure who have been treated with renal denervation since January 2010 or who will undergo renal denervation after March 2025.
- Conditions
- Hypertension (HTN)
- Keywords
- Hypertension (HTN), RDN, Renal denervation
- Medical subject headings
- Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in SBP measured by HBPM before and after RDN (1 year).
Measurement of home blood pressure before and 1 year after RDN
Measured: before intervention and 1 year after intervention
Secondary outcomes (8)
Evaluate changes in office systolic blood pressure using the combination of SBP measured in HBPM and 24-hour-Automatic Blood Pressures Measurements (ABPM) before, 3 months, 6 months and 1 year, after DNR treatment.
collection of home systolic blood pressures and 24-hour-Automatic Blood Pressures Measurements before, 3 months, 6 months and 1 year, after DNR treatment.
Measured: before the DNR intervention and 3, 6, 12 months after DNR intervention
Evaluate the evolution at 3 months, 6 months, 1 year, of the drug burden in antihypertensive treatment, the percentage of patients having reached the blood pressure target and the win ratio.
Collection of treatments taken by the patient and des Blood pressures values
Measured: Before intervention and 1-3, 6, 12 months after DNR intervention
Evaluate the development of renal artery stenosis before and 6 months, 1 year, after DNR.
Appearance of renal artery stenosis on Renal Arteries ultrasound or Renal arteries CT angiography images
Measured: before DNR, 6, 12 months after DNR
Evolution of creatinine levels before and 6 months, 1 year, after DNR.
collection of blood creatinine value
Measured: before, 6 and 12 months after DNR
Evaluate the occurrence of other complications related to hypertension or to the procedure itself
Collection of adverse events and complications after DNR
Measured: from DNR intervention to 1 year follow up
Comparison of responders and non-responders to the procedure (24h ABPM systolic blood pressure decrease of 5 mmHg or more and/or the diminution of the medical burden by at least one therapeutic class without SBP increase compared to baseline).
Collection of systolic blood pressure measurements and medical treatment from inclusion to 1 year after the DNR procedure.
Measured: inclusion, 1, 6, 12 months after the DNR procedure
Evaluate the performance of known predictors of response to renal denervation in our population.
To investigate how well known predictors of response to renal denervation work in patients in our group
Measured: from inclusion to 1 year follow up after the procedure
Describe the type of center performing the procedure, the context in which DNR is performed, patient characteristics and care pathways.
Collection of type of center performing the DNR procedure, the indication for the DNR procedure, patient characteristics and care pathways.
Measured: from inclusion to 1 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start23 Jun 2025
- Primary completionApr 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension (HTN)Studies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier ORMEZZANO, Doctor of medicine, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07206030
- Sponsor's protocol ID
- 38RC25.0159
- Other IDs
- 23540206
- Acronym
- FRIEND
- Status last verified
- Sep 2025
- First submitted
- 25 Sep 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FRiEND Registry: Real Life Data From Hypertensive Patients Treated With Renal Denervation in Current Practice in France- French RENal Denervation Registry
- ClinicalTrials.gov ID
- NCT07206030
- Acronym / sponsor ID
- FRIEND / 38RC25.0159
- Conditions
- Hypertension (HTN)
- Keywords
- Hypertension (HTN), RDN, Renal denervation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 23 Jun 2025 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 3 Oct 2025 (actual)
- 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.
Renal denervation (RDN) is a recent procedure that can be used to control BP (blood pressure) in hypertensive patients. Numerous publications from randomised trials have demonstrated the efficacy of RDN in this indication. The latest guidelines now include RDN as an effective technique for use in hypertension. Since early 2023, RDN using Medtronic's Spiral radiofrequency system has benefited from transitional authorisation for reimbursement by the French health insurance system. An application for reimbursement is underway for the ultrasound system. We aim to compile an exhaustive prospective register of all procedures carried out in France over the next few years, regardless of the type of catheter used or the context in which the procedure was carried out (transitional reimbursement, industrial register, randomised trial). Our aim is to assess the efficacy and safety of the procedure within the French healthcare system, the characteristics of patients benefiting from the procedure, the centres performing renal denervation, and the care pathways used, and to be able to present all this data, independently of the industry, to the healthcare authorities when it comes time to reassess the value of this procedure and its indications. The goal of this observational study is to learn about changes in blood pressure in patient with high blood pressure before and 1 year after a renal denervation treatment (RDN).
The primary endpoint is to describe changes in systolic blood pressure (SBP) measured by Home Blood Pressure Measurement (HBPM) in patients suffering from high blood pressure, before and 1 year after RDN.
Detailed description
This study concerns patients with high blood pressure who have been treated with renal denervation since January 2010 or who will undergo renal denervation after March 2025.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a confirmed diagnosis of high blood pressure, eligible for a renal denervation
Key inclusion criteria (1 listed)
- Adult ( > 18 years old) hypertensive patients treated with RDN in France whatever the catheter and the indication. This might include retrospective data for patient already treated with RDN in the past.
Key exclusion criteria (1 listed)
- RDN not proposed to the patient, patient opposing the collection and use of his/her data for research purposes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in SBP measured by HBPM before and after RDN (1 year).
Time frame: before intervention and 1 year after intervention
Measurement of home blood pressure before and 1 year after RDN
8 secondary outcomes
Evaluate changes in office systolic blood pressure using the combination of SBP measured in HBPM and 24-hour-Automatic Blood Pressures Measurements (ABPM) before, 3 months, 6 months and 1 year, after DNR treatment.
Time frame: before the DNR intervention and 3, 6, 12 months after DNR intervention
Evaluate the evolution at 3 months, 6 months, 1 year, of the drug burden in antihypertensive treatment, the percentage of patients having reached the blood pressure target and the win ratio.
Time frame: Before intervention and 1-3, 6, 12 months after DNR intervention
Evaluate the development of renal artery stenosis before and 6 months, 1 year, after DNR.
Time frame: before DNR, 6, 12 months after DNR
Evolution of creatinine levels before and 6 months, 1 year, after DNR.
Time frame: before, 6 and 12 months after DNR
Evaluate the occurrence of other complications related to hypertension or to the procedure itself
Time frame: from DNR intervention to 1 year follow up
Comparison of responders and non-responders to the procedure (24h ABPM systolic blood pressure decrease of 5 mmHg or more and/or the diminution of the medical burden by at least one therapeutic class without SBP increase compared to baseline).
Time frame: inclusion, 1, 6, 12 months after the DNR procedure
Evaluate the performance of known predictors of response to renal denervation in our population.
Time frame: from inclusion to 1 year follow up after the procedure
Describe the type of center performing the procedure, the context in which DNR is performed, patient characteristics and care pathways.
Time frame: from inclusion to 1 year follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Individual participant dataSharing planned: Undecided
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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.
Olivier ORMEZZANO, Doctor of medicine principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension (HTN), run by University Hospital, Grenoble at 1 site in France.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 3 Oct 2025. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olivier ORMEZZANO, Doctor of medicine (+33476768888, oormezzano@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in SBP measured by HBPM before and after RDN (1 year). (time frame: before intervention and 1 year after intervention). 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 3 Oct 2025.