The Effect of Renal Denervation on Renal Flow in Humans

NCT01848314 | Completed

• 1 other identifier: NL42766.041.12
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Change in microvascular resistance

  Within 30 minutes after renal denervation

Secondary Outcomes (1)

• change in average flow velocity

  within 30 minutes after renal denervation

Other Outcomes (1)

• safety of measurement

  within 24 hour after renal denervation

Study Arms (1)

Patients undergoing renal denervation

EXPERIMENTAL

patients diagnosed with resistant hypertension, eligible to undergo renal denervation

Procedure: Renal Denervation

Interventions

Renal Denervation PROCEDURE

Flowmeasurements will be performed before and after renal denervation

Also known as: flowmeasurements

Patients undergoing renal denervation

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• UMC Utrecht: lead

Study Sites (1)

UMC Utrecht

Utrecht, Utrecht, 3584CX, Netherlands

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Michiel Voskuil, MD, PhD

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 26, 2013
• First Posted: May 7, 2013
• Study Start: April 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: June 8, 2015

Record last verified: 2015-06

Locations

NL (1)