Chu Grenoble Alpes
La Tronche, France, 38700
Location status: Recruiting
Location contact
Delphine POLLET, Master
CONTACT
Olivier ORMEZZANO, Doctor of medicine
CONTACT
Olivier ORMEZZANO, Doctor of medicine
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07206030
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
La Tronche, France, 38700
Location status: Recruiting
Delphine POLLET, Master
CONTACT
Olivier ORMEZZANO, Doctor of medicine
CONTACT
Olivier ORMEZZANO, Doctor of medicine
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: before intervention and 1 year after intervention
Measurement of home blood pressure before and 1 year after RDN
Time frame: 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.
Time frame: Before intervention and 1-3, 6, 12 months after DNR intervention
Collection of treatments taken by the patient and des Blood pressures values
Time frame: before DNR, 6, 12 months after DNR
Appearance of renal artery stenosis on Renal Arteries ultrasound or Renal arteries CT angiography images
Time frame: before, 6 and 12 months after DNR
collection of blood creatinine value
Time frame: from DNR intervention to 1 year follow up
Collection of adverse events and complications after DNR
Time frame: 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.
Time frame: 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
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Olivier ORMEZZANO, Doctor of medicine
CONTACT
Olivier pollet, Master
CONTACT
University Hospital, Grenoble
Other
FRiEND Registry: Real Life Data From Hypertensive Patients Treated With Renal Denervation in Current Practice in France- French RENal Denervation Registry
Acronym: FRIEND
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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