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TerminatedNCT05818813RDN flowUpdated Mar 27, 2026

The Long-term Safety and Effect of Renal Denervation

An observational study in Hypertension, sponsored by Imperial College Healthcare NHS Trust. Terminated at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-27.

Sponsored by Imperial College Healthcare NHS Trust · Observational

Why this study was terminated
Guidewires used in the study are no longer manufactured
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
9
Ages
18 Years and older
Sex
All
01

Study summary

The goal of this observational study is to learn about the effects of renal denervation in patients with resistant hypertension. The main question it aims to answer is: What are the long term effects of renal denervation on blood pressure and flow within the arteries? Participants will undergo an assessment of their blood pressure, echocardiogram and invasive measurements of blood pressure and flow in the aorta and renal arteries before undergoing the renal denervation procedure. 6 months later these assessments will be repeated.

Read the detailed description

Renal denervation is emerging as a succesful technique in the treatment of high blood pressure particularly for those people who's disease is resistant to drug therapy. It involves insertion of an catheter through the femoral artery and into the renal artery where it delivers a controlled radiofrequency ablation to the renal artery wall.

The purpose of this ablation is to interupt the sympathetic nervous system which is inappropriately activated in hypertension. Its beneficial effects on BP reduction has been borne out in a recently published randomised clinical trial which demonstrated a reduction in blood pressure in patients who underwent denervation compared to those managed with medication alone and it is now being used worldwide to manage hypertensive patients.

The safety of this procedure has been demonstrated in the peri-operative setting and short term particularly regarding anatomical changes and kidney function. However, its effects have not been demonstrated with invasive imaging or physiological testing in the long term. Therefore, the investigators recognise that a repeat assessment 6 months after denervation using invasive measures (to perform detailed assessments of the effects on aortic, flow and artery stiffness) would be of great benefit in stratifying this technique, which is likely to become widespread in the very near future.

The investigators therefore plan to perform denervation in 20 patients and obtain detailed information on kidney and aortic blood pressure and flow. They will then reassess these parameters after 6 months in the same patients to ensure preservation of pressure, flow and energy transfer and document the effects of denervation on vascular stiffness.

02

Conditions studied

  • Hypertension

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Keywords

  • Hypertension
  • Renal denervation
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 9 is below the median of 210 across 1,359 observational studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Imperial College Healthcare NHS Trust is the lead sponsor of 79 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

People with resistant hypertension and no contraindication to renal denervation.

Inclusion criteria

  • Systolic blood pressure >160mmHg despite 3 antihypertensive agents
  • eGFR >45

Exclusion criteria

Exclusion Criteria:

  • Secondary causes of hypertension
  • Prior renal artery intervention
  • Renal insufficiency
  • Significant stenotic valvular heart disease
  • Myocardial infarction, unstable angina or stroke within the preceding 6 months
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
9 participants (actual)
Patient registry
No

Interventions

  • DeviceRenal denervation

    Renal denervation (ReCor Medical)

06

What researchers measure

Primary outcomes

  1. Change in systolic blood pressure

    Invasively measured aortic systolic pressure

    Time frame: At baseline and at 6 months

Secondary outcomes

  1. Change in diastolic pressure

    Invasively measured aortic diastolic pressure

    Time frame: At baseline and 6 months

  2. Change in renal artery pressure

    Invasively measured

    Time frame: At baseline and 6 months

  3. Change in renal artery flow

    Invasively measured

    Time frame: At baseline and 6 months

  4. Change in renal artery resistance

    Invasively measured

    Time frame: At baseline and 6 months

  5. Change in aortic reservoir pressure

    Invasively measured

    Time frame: At baseline and 6 months

  6. Change in aortic wavespeed

    Invasively measured

    Time frame: At baseline and 6 months

  7. Change in aortic reservoir wave intensity

    Invasively measured

    Time frame: At baseline and 6 months

  8. Change in left ventricular wall thickness

    Assessed during echocardiography

    Time frame: At baseline and 6 months

07

Study locations

1 site
  • Hammersmith Hospital
    London, Middlesex W12 0HS, United Kingdom
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05818813
Lead sponsor
Imperial College Healthcare NHS Trust
Collaborators
Philips Healthcare
Responsible party
Sponsor
First posted
Apr 19, 2023
Start date
Apr 27, 2021
Primary completion
Apr 16, 2024
Completion
Apr 16, 2024
Last update
Mar 27, 2026

Study contacts

Sayan Sen, PhD
principal investigator · Consultant Cardiologist

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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