The Effect of Renal Denervation on Renal Flow in Humans

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Procedure: Renal Denervation

• Registration Number: NCT01848314
• Lead Sponsor: UMC Utrecht

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-26
• Study First Submitted QC: 2013-05-06
• Study First Posted: 2013-05-07
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-04
• Last Update Posted: 2015-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients undergoing renal denervation	Renal Denervation	patients diagnosed with resistant hypertension, eligible to undergo renal denervation

Primary Outcome Measures

Name	Time	Method
Change in microvascular resistance	Within 30 minutes after renal denervation

Secondary Outcome Measures

Name	Time	Method
change in average flow velocity	within 30 minutes after renal denervation

Trial Locations

Locations (1)

UMC Utrecht; 🇳🇱 Utrecht, Netherlands