Clinical trial NCT05818813: The Long-term Safety and Effect of Renal Denervation
Official title: The Long-term Safety and Effect of Renal Denervation for Resistant Hypertension
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypertension
Keywords: Hypertension
Renal denervation
Lead sponsor: Imperial College Healthcare NHS Trust
Sponsor class: OTHER
Collaborators: name: Philips Healthcare
First posted: 2023-04-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People with resistant hypertension and no contraindication to renal denervation.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in systolic blood pressure
timeFrame: At baseline and at 6 months
Secondary outcomes:
measure: Change in diastolic pressure
timeFrame: At baseline and 6 months
measure: Change in renal artery pressure
timeFrame: At baseline and 6 months
measure: Change in renal artery flow
timeFrame: At baseline and 6 months
measure: Change in renal artery resistance
timeFrame: At baseline and 6 months
measure: Change in aortic reservoir pressure
timeFrame: At baseline and 6 months
measure: Change in aortic wavespeed
timeFrame: At baseline and 6 months
measure: Change in aortic reservoir wave intensity
timeFrame: At baseline and 6 months
measure: Change in left ventricular wall thickness
timeFrame: At baseline and 6 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Hammersmith Hospital
state: Middlesex
Study officials:
affiliation: Consultant Cardiologist
name: Sayan Sen, PhD
role: PRINCIPAL_INVESTIGATOR
References: