How to Test Success of a Renal Denervation

Terminated

• Conditions: Hypertension, Resistant to Conventional Therapy

• Registration Number: NCT02559882
• Lead Sponsor: University of Zurich

Brief Summary

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.

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

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-08-24
• Study First Submitted QC: 2015-09-24
• Study First Posted: 2015-09-25
• Primary Completion: 2018-12-21
• Study Completion: 2018-12-21
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-10
• Last Update Posted: 2019-01-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response to adenosine infusion, cold pressure test, flow mediated dilation of renal artery before and 1 year after renal denervation B	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	chronic

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Cardiology University Heart Center Zurich University Hospital; 🇨🇭 Zurich, Switzerland