How to Test Success of a Renal Denervation

NCT02559882 | Terminated

• 1 other identifier: EK2015_0045
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension, Resistant to Conventional Therapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

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

  chronic

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

Department of Cardiology University Heart Center Zurich University Hospital

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Hypertension Resistant to Conventional Therapy

Study Officials

• Isabella Sudano, MD Phd

  University Heart Center Cardiology University Hospital Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2015
• First Posted: September 25, 2015
• Study Start: August 1, 2015
• Primary Completion: December 21, 2018
• Study Completion: December 21, 2018
• Last Updated: January 14, 2019

Record last verified: 2019-01

Locations

CH (1)