Hypertension (HTN)
Conditions
Keywords
Hypertension (HTN), RDN, Renal denervation
Brief 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. 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.
Interventions
None listed
Sponsors
University Hospital, Grenoble
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* RDN not proposed to the patient, patient opposing the collection and use of his/her data for research purposes.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in SBP measured by HBPM before and after RDN (1 year). | before intervention and 1 year after intervention | Measurement of home blood pressure before and 1 year after RDN |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Before intervention and 1-3, 6, 12 months after DNR intervention | Collection of treatments taken by the patient and des Blood pressures values |
| Evaluate the development of renal artery stenosis before and 6 months, 1 year, after DNR. | before DNR, 6, 12 months after DNR | Appearance of renal artery stenosis on Renal Arteries ultrasound or Renal arteries CT angiography images |
| Evolution of creatinine levels before and 6 months, 1 year, after DNR. | before, 6 and 12 months after DNR | collection of blood creatinine value |
| 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. | before the DNR intervention and 3, 6, 12 months after DNR intervention | collection of home systolic blood pressures and 24-hour-Automatic Blood Pressures Measurements before, 3 months, 6 months and 1 year, after DNR treatment. |
| 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). | inclusion, 1, 6, 12 months after the DNR procedure | Collection of systolic blood pressure measurements and medical treatment from inclusion to 1 year after the DNR procedure. |
| Evaluate the performance of known predictors of response to renal denervation in our population. | from inclusion to 1 year follow up after the procedure | To investigate how well known predictors of response to renal denervation work in patients in our group |
| Describe the type of center performing the procedure, the context in which DNR is performed, patient characteristics and care pathways. | from inclusion to 1 year follow-up | Collection of type of center performing the DNR procedure, the indication for the DNR procedure, patient characteristics and care pathways. |
| Evaluate the occurrence of other complications related to hypertension or to the procedure itself | from DNR intervention to 1 year follow up | Collection of adverse events and complications after DNR |
Countries
France
Contacts
Primary ContactOlivier ORMEZZANO, Doctor of medicine
Backup ContactOlivier pollet, Master
Outcome results
None listed