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The Effect of Renal Denervation on Biological Variables

NCT01427049 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 54

Last updated 2017-02-02

No results posted yet for this study

Summary

Hypertension is a major and growing public health concern. Chronic elevation of sympathetic nervous system (SNS) activity has been identified as a major contributor to the complex pathophysiology of (essential) hypertension. The renal sympathetic nerves play a major role in the elevation of the SNS activity. Therapeutic renal denervation (RD), the deliberate disruption of the nerves connecting the kidneys with the central nervous system, has been shown to be an effective means of modulating elevated SNS activity - both by reducing the sympathetic modulation of renal function (renin release, sodium excretion and renal blood flow) and by removing the renal afferent sympathetic contribution to central blood pressure elevation.

This current study is an observational exploratory study. The main objective of this study is to learn more on the effects of RD. We wish to do that by quantifying the effects of RD on various biological variables. Those variables are studied in four sets of investigations: a radiological set, a laboratorial set, a set of blood pressure measurements and a set of investigations in the vascular laboratory. The radiological set consists of imaging of the heart and kidney function (renal perfusion) and structure (renal arteries), the laboratorial set of serum and urine tests, 24 h- home- and office- blood pressure measurements will be taken and finally the set of vascular tests contains investigations on pulse wave velocity(PWV) and heart rate variability(HRV). The data will most likely help us to define future studies, to describe the mode of action and the effects of RD on various organs and systems in more detail, and finally to define in more detail which type of hypertensive patients is especially likely to benefit of the procedure.

Hypothesis:

* We hypothesize that LV mass will decrease after RD. Because all patients have severe hypertension, it is likely that a substantial percentage will have increased LV mass.
* We hypothesize that renal perfusion and renal oxygenation increase after RD.
* We hypothesize that there will be no complications related to the device or procedure.
* We hypothesize that renal denervation has a beneficial effect on insulin resistance
* We hypothesize that renal denervation will decrease the blood pressure(office and 24-hour-measurements)
* We hypothesize that RD has a beneficial effect on PWV and HRV.

Conditions

Interventions

DEVICE

renal denervation

percutaneous selective renal sympathetic denervation with the use of the Symplicity Catheter system

Sponsors & Collaborators

  • UMC Utrecht

    lead OTHER

Principal Investigators

  • Peter Blankestijn, Dr. · UMC Utrecht department of Nephrology and Hypertension

  • Eva Vink, PhD Student · UMC Utrecht Department of Nephrology and Hypertension

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2014-02-28
Completion
2014-02-28

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01427049 on ClinicalTrials.gov