NCT02345603

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
9

participants targeted

Target at below P25 for phase_4 hypertension

Timeline
Completed

Started Dec 2014

Longer than P75 for phase_4 hypertension

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

December 18, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 26, 2015

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

April 24, 2019

Status Verified

April 1, 2019

Enrollment Period

6 years

First QC Date

December 18, 2014

Last Update Submit

April 23, 2019

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Blood pressure levels

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

    2 months

Secondary Outcomes (1)

  • Levels of epinephrine and nor-epinephrine in urine

    before and 2 months after surgery

Study Arms (2)

Cryo-therapy

EXPERIMENTAL

Cryo-therapy of renal arteries

Procedure: Cryo-therapy

Control

NO INTERVENTION

No intervention in renal arteries

Interventions

Cryo-therapyPROCEDURE

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

Cryo-therapy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • planned prophylactic surgery for abdominal aortic aneurysm

You may not qualify if:

  • hypotension,
  • inability to understand study protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Linkoping

Linköping, 58185, Sweden

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD professor Head of internal medicine

Study Record Dates

First Submitted

December 18, 2014

First Posted

January 26, 2015

Study Start

December 1, 2014

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

April 24, 2019

Record last verified: 2019-04

Locations

SE(1)