Real Life Data From Hypertensive Patients Treated With Renal Denervation in Current Practice in France- French RENal Denervation Registry

NCT07206030 | Recruiting

• 2 other identifiers: 38RC25.015923540206
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension (HTN)

Keywords

Hypertension (HTN); RDN; Renal denervation

Outcome Measures

Primary Outcomes (1)

• Change in SBP measured by HBPM before and after RDN (1 year).

  Measurement of home blood pressure before and 1 year after RDN

  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.

  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.

  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.

  before DNR, 6, 12 months after DNR

• Evolution of creatinine levels before and 6 months, 1 year, after DNR.

  before, 6 and 12 months after DNR

• Evaluate the occurrence of other complications related to hypertension or to the procedure itself

  from DNR intervention to 1 year follow up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a confirmed diagnosis of high blood pressure, eligible for a renal denervation

You may qualify if:

• 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.

You may not qualify if:

• RDN not proposed to the patient, patient opposing the collection and use of his/her data for research purposes.

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

Chu Grenoble Alpes

La Tronche, France, 38700, France

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Olivier ORMEZZANO, Doctor of medicine

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olivier ORMEZZANO, Doctor of medicine

CONTACT

+33476768888; oormezzano@chu-grenoble.fr

Olivier pollet, Master

CONTACT

+33476768823; dpollet@chu-grenoble.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2025
• First Posted: October 3, 2025
• Study Start: June 23, 2025
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: October 3, 2025

Record last verified: 2025-09

Locations

FR (1)