How to Test Success of a Renal Denervation

Hypertension, Resistant to Conventional Therapy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02559882
• Other study ID #: EK2015_0045
• Status: Terminated
• Start date: August 2015
• Est. completion date: December 21, 2018

Study information

• Verified date: January 2019
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: December 21, 2018
• Est. primary completion date: December 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Vasospasm
• Hypertension
• Hypertension, Resistant to Conventional Therapy

Locations

Country	Name	City	State
Switzerland	Department of Cardiology University Heart Center Zurich University Hospital	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	lood pressure (office and 24-hour blood pressure), laboratory parameter before and 12 months after catheter-based renal denrevation		chronic
Secondary	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