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
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.