The Long-term Safety and Effect of Renal Denervation

Hypertension Clinical Trial

— RDN flow  

Official title:

The Long-term Safety and Effect of Renal Denervation for Resistant Hypertension

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05818813
• Other study ID #: 14/LO/0026
• Status: Recruiting
• Start date: April 27, 2021
• Est. completion date: January 1, 2025

Study information

• Verified date: April 2023
• Source: Imperial College Healthcare NHS Trust
• Contact: Rahul Bahl, MBBS
• Phone: +44 207 082 5109
• Email: r.bahl[@]imperial.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Systolic blood pressure >160mmHg despite 3 antihypertensive agents

• eGFR >45

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Device:
• Renal denervation
Renal denervation (ReCor Medical)

Locations

Country	Name	City	State
United Kingdom	Hammersmith Hospital	London	Middlesex

Sponsors (2)

Lead Sponsor	Collaborator
Imperial College Healthcare NHS Trust	Philips Healthcare

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in systolic blood pressure	Invasively measured aortic systolic pressure	At baseline and at 6 months
Secondary	Change in diastolic pressure	Invasively measured aortic diastolic pressure	At baseline and 6 months
Secondary	Change in renal artery pressure	Invasively measured	At baseline and 6 months
Secondary	Change in renal artery flow	Invasively measured	At baseline and 6 months
Secondary	Change in renal artery resistance	Invasively measured	At baseline and 6 months
Secondary	Change in aortic reservoir pressure	Invasively measured	At baseline and 6 months
Secondary	Change in aortic wavespeed	Invasively measured	At baseline and 6 months
Secondary	Change in aortic reservoir wave intensity	Invasively measured	At baseline and 6 months
Secondary	Change in left ventricular wall thickness	Assessed during echocardiography	At baseline and 6 months