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Completed

NCT Number: NCT01848314

The Effect of Renal Denervation on Renal Flow in Humans

Many studies have studied the effect and safety of renal denervation. However, it remains unknown what the exact mechanism behind renal denervation is. It can be hypothesized that a difference in renal blood flow occurs after treatment. In the light of this ignorance, current study will investigate whether renal denervation leads to a difference in renal blood flow after treatment with renal denervation.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UMC Utrecht

Utrecht, 3584CX, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Individual is scheduled to undergo renal denervation as standard patient care for resistant hypertension.
  • Individual is diagnosed with resistant hypertension. Secondary causes and a white coat hypertension are actively excluded.
  • Individual is ≥18 years of age.
  • Individual agrees to have all study procedures performed, and is competent and willing to provide written informed consent to participate in this clinical study.

Exclusion criteria

  • Individual is excluded from treatment with pRDN .
  • Individual has an estimated glomerular filtration rate (eGFR) of <30mL/min/1.73m2, using the MDRD calculation.
  • Individual has experienced a myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within 6 months of the screening visit, or has widespread atherosclerosis, with documented intravascular thrombosis or unstable plaques.
  • Individual has any serious medical condition, which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant or the study (i.e., patients with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, haemophilia or significant anaemia).
  • Individual is pregnant, nursing or planning to be pregnant.
  • Individual has a known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or would be unlikely or unable to comply with study follow-up requirements.

Treatment and study plan

Renal Denervation

Procedure

Flowmeasurements will be performed before and after renal denervation

Other names: flowmeasurements

Primary outcomes

  1. Change in microvascular resistance

    Time frame: Within 30 minutes after renal denervation

Secondary outcomes

  1. change in average flow velocity

    Time frame: within 30 minutes after renal denervation

Other outcomes

  1. safety of measurement

    Time frame: within 24 hour after renal denervation

Sponsors and collaborators

Lead sponsor

UMC Utrecht

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
May 7, 2013
Registry last updated
Jun 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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