HypertensionPhase 4PRASDENNCT02345603
Pilot Study of of Renal Arterial Sympathetic Denervation by Cryotherapy
A Phase 4 study testing Cryo-therapy in people with Hypertension, run by University Hospital, Linkoeping at 1 site in Sweden.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypertension
- What is being tested?
- Cryo-therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteSweden
- Study dates
- Dec 2014to Dec 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- planned prophylactic surgery for abdominal aortic aneurysm
Who cannot join
- hypotension,
- inability to understand study protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study of of Renal Arterial Sympathetic Denervation by Cryotherapy During Open Surgery for Aortic Aneurysm
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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- Cryo-therapy
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryo-therapyProcedure or surgery
Cryo-therapy for about 60 seconds applied circumpherentially to each renal artery
| Study group | Role | What they receive |
|---|---|---|
| Cryo-therapy | Experimental | Cryo-therapy of renal arteries Receives: Procedure: Cryo-therapy |
| Control | No intervention | No intervention in renal arteries |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure levels
24 hour mean ambulatory blood pressure levels before and 2 months after surgery
Measured: 2 months
Secondary outcomes (1)
Levels of epinephrine and nor-epinephrine in urine
Collection of urine for analyses of stress hormones
Measured: before and 2 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Study startDec 2014
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Linkoeping
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fredrik H Nystrom, University Hospital, Linkoeping
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02345603
- Sponsor's protocol ID
- 2014/45-31
- Acronym
- PRASDEN
- Status last verified
- Apr 2019
- First submitted
- 18 Dec 2014
- Last updated
- 24 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of of Renal Arterial Sympathetic Denervation by Cryotherapy During Open Surgery for Aortic Aneurysm
- ClinicalTrials.gov ID
- NCT02345603
- Acronym / sponsor ID
- PRASDEN / 2014/45-31
- Conditions
- Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University Hospital, LinkoepingUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 26 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cryo-therapy | Experimental | Procedure: Cryo-therapyCryo-therapy of renal arteries |
| Control | No intervention | –No intervention in renal arteries |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- planned prophylactic surgery for abdominal aortic aneurysm
Key exclusion criteria (2 listed)
- hypotension,
- inability to understand study protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cryo-therapyCryo-therapy for about 60 seconds applied circumpherentially to each renal artery | Procedure or surgery | Cryo-therapy |
Primary outcome
Blood pressure levels
Time frame: 2 months
24 hour mean ambulatory blood pressure levels before and 2 months after surgery
1 secondary outcome
Levels of epinephrine and nor-epinephrine in urine
Time frame: before and 2 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cryo-therapy in people with Hypertension, run by University Hospital, Linkoeping at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure levels (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2019.