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NCT02345603 Clinical Trial

Pilot Study of of Renal Arterial Sympathetic Denervation by Cryotherapy

Hypertension Clinical Trial

— PRASDEN  

Official title:
Pilot Study of of Renal Arterial Sympathetic Denervation by Cryotherapy During Open Surgery for Aortic Aneurysm

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02345603
Other study ID # 2014/45-31
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received
Last updated
Start date December 2014
Est. completion date December 2020

Study information
Verified date April 2019
Source University Hospital, Linkoeping
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Non-randomized study of 5 subjects that have been selected for prophylactic open surgery due to abdominal aortic aneurysm. During surgery the renal arteries are identified and subjected to about 60 seconds each of freezing by application of liquid nitrogen in dedicated catheters around the circumference of each artery. Another 5 patients that are not subjected to the freeze therapy serve as controls. Main outcome is change in ambulatory blood pressure levels.

Description:

Non-randomized study of 5 subjects that have been selected for prophylactic open surgery due to abdominal aortic aneurysm. During the surgery the renal arteries at both sides are identified and subjected to about 60 seconds each of freezing by application of liquid nitrogen in dedicated catheters around the circumference of each artery. Renal arterial blood flow is checked by Doppler after the freezing procedure, during the surgery. Another 5 patients that are not subjected to the freeze therapy serve as controls. Main outcome is change in 24h ambulatory blood pressure levels and of course safety parameters such as creatinine levels.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 9
Est. completion date December 2020
Est. primary completion date December 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- planned prophylactic surgery for abdominal aortic aneurysm

Exclusion Criteria:

- hypotension,

- inability to understand study protocol

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Cryo-therapy
Cryo-therapy for about 60 seconds applied circumpherentially to each renal artery

Locations
Country Name City State
Sweden University Hospital of Linkoping Linkoping

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Linkoeping

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Blood pressure levels 24 hour mean ambulatory blood pressure levels before and 2 months after surgery 2 months
Secondary Levels of epinephrine and nor-epinephrine in urine Collection of urine for analyses of stress hormones before and 2 months after surgery
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