NCT05818813

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 27, 2021

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

March 22, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

April 19, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 16, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 16, 2024

Completed
Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

3 years

First QC Date

March 22, 2023

Last Update Submit

March 24, 2026

Conditions

Hypertension

Keywords

HypertensionRenal denervation

Outcome Measures

Primary Outcomes (1)

  • Change in systolic blood pressure

    Invasively measured aortic systolic pressure

    At baseline and at 6 months

Secondary Outcomes (8)

  • Change in diastolic pressure

    At baseline and 6 months

  • Change in renal artery pressure

    At baseline and 6 months

  • Change in renal artery flow

    At baseline and 6 months

  • Change in renal artery resistance

    At baseline and 6 months

  • Change in aortic reservoir pressure

    At baseline and 6 months

  • +3 more secondary outcomes

Interventions

Renal denervationDEVICE

Renal denervation (ReCor Medical)

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

People with resistant hypertension and no contraindication to renal denervation.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hammersmith Hospital

London, Middlesex, W12 0HS, United Kingdom

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Sayan Sen, PhD

    Consultant Cardiologist

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2023

First Posted

April 19, 2023

Study Start

April 27, 2021

Primary Completion

April 16, 2024

Study Completion

April 16, 2024

Last Updated

March 27, 2026

Record last verified: 2026-03

Locations

GB(1)