How to Test Success of a Renal Denervation

Testing Effectiveness of Renal Denervation in Patients With Therapy-resistant Hypertension

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.

Study Overview

• Status: Terminated
• Conditions: Hypertension, Resistant to Conventional Therapy

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 Type: Observational
• Enrollment (Actual): 11

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8091
    • Department of Cardiology University Heart Center Zurich University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patient with therapy resistant hypertension and clinical indication for renal nerve ablation

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Zurich
• Investigators: Principal Investigator: Isabella Sudano, MD Phd, University Heart Center Cardiology University Hospital Zurich

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): December 21, 2018
• Study Completion (Actual): December 21, 2018

Study Registration Dates

• First Submitted: August 24, 2015
• First Submitted That Met QC Criteria: September 24, 2015
• First Posted (Estimate): September 25, 2015

Study Record Updates

• Last Update Posted (Actual): January 14, 2019
• Last Update Submitted That Met QC Criteria: January 10, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: EK2015_0045