The Effect of Renal Denervation on Renal Flow in Humans

Hypertension Clinical Trial

Official title:

The Effect of Renal Denervation on Renal Flow in Humans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01848314
• Other study ID #: NL42766.041.12
• Status: Completed
• Phase: N/A
• First received: April 26, 2013
• Last updated: June 4, 2015
• Start date: April 2013
• Est. completion date: September 2014

Study information

• Verified date: June 2015
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Hypertension

Intervention

Procedure:
• Renal Denervation
Flowmeasurements will be performed before and after renal denervation

Locations

Country	Name	City	State
Netherlands	UMC Utrecht	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	safety of measurement		within 24 hour after renal denervation	Yes
Primary	Change in microvascular resistance		Within 30 minutes after renal denervation	No
Secondary	change in average flow velocity		within 30 minutes after renal denervation	No