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Pilot Study of of Renal Arterial Sympathetic Denervation by Cryotherapy (PRASDEN)

Primary Purpose

Hypertension

Status
Unknown status
Phase
Phase 4
Locations
Sweden
Study Type
Interventional
Intervention
Cryo-therapy
Sponsored by
University Hospital, Linkoeping
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • planned prophylactic surgery for abdominal aortic aneurysm

Exclusion Criteria:

  • hypotension,
  • inability to understand study protocol

Sites / Locations

  • University Hospital of Linkoping

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cryo-therapy

Control

Arm Description

Cryo-therapy of renal arteries

No intervention in renal arteries

Outcomes

Primary Outcome Measures

Blood pressure levels
24 hour mean ambulatory blood pressure levels before and 2 months after surgery

Secondary Outcome Measures

Levels of epinephrine and nor-epinephrine in urine
Collection of urine for analyses of stress hormones

Full Information

First Posted
December 18, 2014
Last Updated
April 23, 2019
Sponsor
University Hospital, Linkoeping
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1. Study Identification

Unique Protocol Identification Number
NCT02345603
Brief Title
Pilot Study of of Renal Arterial Sympathetic Denervation by Cryotherapy
Acronym
PRASDEN
Official Title
Pilot Study of of Renal Arterial Sympathetic Denervation by Cryotherapy During Open Surgery for Aortic Aneurysm
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 2014 (undefined)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Linkoeping

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cryo-therapy
Arm Type
Experimental
Arm Description
Cryo-therapy of renal arteries
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention in renal arteries
Intervention Type
Procedure
Intervention Name(s)
Cryo-therapy
Intervention Description
Cryo-therapy for about 60 seconds applied circumpherentially to each renal artery
Primary Outcome Measure Information:
Title
Blood pressure levels
Description
24 hour mean ambulatory blood pressure levels before and 2 months after surgery
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Levels of epinephrine and nor-epinephrine in urine
Description
Collection of urine for analyses of stress hormones
Time Frame
before and 2 months after surgery

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: planned prophylactic surgery for abdominal aortic aneurysm Exclusion Criteria: hypotension, inability to understand study protocol
Facility Information:
Facility Name
University Hospital of Linkoping
City
Linkoping
ZIP/Postal Code
58185
Country
Sweden

12. IPD Sharing Statement

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