How to Test Success of a Renal Denervation

Overview

The study aimed to assess the success of a clinically indicated renal denervation by different tests and correlate the results of the tests with the clinical outcome.

Full Title of Study: “Testing Effectiveness of Renal Denervation in Patients With Therapy-resistant Hypertension”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 21, 2018

Detailed Description

We aim to test the response to adenosine infusion, cold pressure test, flow mediated dilation of renal artery before and after a clinical indicated renal denervation. Renal Denervation is not a study intervention

Clinical Trial Outcome Measures

Primary Measures

  • Response to adenosine infusion, cold pressure test, flow mediated dilation of renal artery before and 1 year after renal denervation B
    • Time Frame: chronic
    • Changes in blood pressure and heart rate, in renal artery diameter and flow during adenosine infusion before and 1 year after renal denervation
  • lood pressure (office and 24-hour blood pressure), laboratory parameter before and 12 months after catheter-based renal denrevation
    • Time Frame: chronic

Secondary Measures

  • Blood pressure (office and 24-hour blood pressure), laboratory parameter before and 1, 3, 6 months after catheter-based
    • Time Frame: chronic
    • Blood pressure (office and 24-hour blood pressure), laboratory parameter before and 1, 3, 6 months after catheter-based

Participating in This Clinical Trial

Inclusion Criteria

Male and female patients 18 years to 85 years of age, with a diagnosis of re-sistant hypertension (office sitting blood pressure >140/90 mmHg and 24-hour blood pressure >130/80 mmHg in patients treated with at least three antihypertensive drugs including a diuretic) and a clinical indication for a renal denervation. Exclusion Criteria:

  • Secondary cause of hypertension – Anatomical contraindication to renal denervation (renal artery diameter less than 4 mm or more than 8 mm), multiple renal artery, length to bifurcation less than 2 cm – Heart failure (normal ejection fractions on echocardiography and no clinical signs and symptoms of heart failure). – Alcohol or drug abuse, – Malignancy (unless healed or remission > 5 years) – Pregnancy – Know allergy to contrast medium – Participation in another study within the last month

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Zurich
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Isabella Sudano, MD Phd, Principal Investigator, University Heart Center Cardiology University Hospital Zurich

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