Renal Artery StenosisPREFFERNCT01128933
Renal Fractional Flow Reserve in Renal Artery Stenting
A study testing Renal artery stenting in people with Renal Artery Stenosis and Hypertension, run by National Institute of Cardiology, Warsaw, Poland at 1 site in Poland.
Trial summary
The purpose of the study is to determine potential utility of renal fractional flow reserve in prognosis predicting after renal stent implantation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Renal Artery Stenosis, Hypertension
- What is being tested?
- Renal artery stenting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 sitePoland
- Study dates
- Jun 2006to May 2010
- Phase
- Interventional
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least moderate (60% or more) renal artery stenosis with atheromatic appearance in angiography
- Hypertension defined according to WHO criteria
- Age 18-75 years
- Signed informed consent obtained
Who cannot join
- Bilateral renal artery stenosis or significant renal artery stenosis in solitary kidney
- Contraindications to percutaneous renal angioplasty with stenting
- Atrophy of the kidney supplied with stenosed artery
- Other well known secondary reason for hypertension
- Chronic heart failure NYHA II-IV
- Significant valvular heart disease qualified for surgery
- Persistent atrial fibrillation
- Renal failure with GFR below 30ml/min
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prognostic Value of Renal Fractional Flow Reserve in Hypertensive Patients With Renal Artery Stenosis Qualified to Renal Artery Stenting
The purpose of the study is to determine potential utility of renal fractional flow reserve in prognosis predicting after renal stent implantation.
- Conditions
- Renal Artery Stenosis, Hypertension
- Being tested
- Renal artery stenting
- Keywords
- Fractional flow reserve, Revascularization, Prognosis, Hemodynamics, Hypertension
- Medical subject headings
- Renal Artery Obstruction, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal artery stentingProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Hypertensive patients | Experimental | Hypertensive patients with at least moderate renal artery stenosis Receives: Procedure: Renal artery stenting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure improvement
Measured: 6 months
Secondary outcomes (1)
Kidney function preservation
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2010 (estimated)
- Study startJun 2006
- Primary completionDec 2009
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Renal Artery StenosisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Cardiology, Warsaw, Poland
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Higher Education, Poland
- Investigators
- Jacek Kadziela, MD,PhD, Principal investigator, National Institute of Cardiology, Warsaw, PolandAdam Witkowski, Prof, Principal investigator, National Institute of Cardiology, Warsaw, PolandAndrzej Januszewicz, Prof, Principal investigator, National Institute of Cardiology, Warsaw, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01128933
- Sponsor's protocol ID
- 2P05B02530
- Acronym
- PREFFER
- Status last verified
- May 2010
- First submitted
- 21 May 2010
- Last updated
- 24 May 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Kadziela J, Prejbisz A, Michalowska I, Adamczak M, Warchol-Celinska E, Pregowska-Chwala B, Januszewicz M, Wiecek A, Januszewicz A, Witkowski A. Relationship between hemodynamic parameters of renal artery stenosis and the changes of kidney function after renal artery stenting in patients with hypertension and preserved renal function. Blood Press. 2015 Feb;24(1):30-4. doi: 10.3109/08037051.2014.958304. Epub 2014 Sep 30.
PubMed 25268986Kadziela J, Januszewicz A, Prejbisz A, Michalowska I, Januszewicz M, Florczak E, Kalinczuk L, Norwa-Otto B, Warchol E, Witkowski A. Prognostic value of renal fractional flow reserve in blood pressure response after renal artery stenting (PREFER study). Cardiol J. 2013;20(4):418-22. doi: 10.5603/CJ.2013.0101.
PubMed 23913461
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Renal Fractional Flow Reserve in Hypertensive Patients With Renal Artery Stenosis Qualified to Renal Artery Stenting
- ClinicalTrials.gov ID
- NCT01128933
- Acronym / sponsor ID
- PREFFER / 2P05B02530
- Conditions
- Renal Artery Stenosis, Hypertension
- Keywords
- Fractional flow reserve, Revascularization, Prognosis, Hemodynamics, Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- National Institute of Cardiology, Warsaw, PolandUniversity, hospital or other
- Collaborators
- Ministry of Science and Higher Education, Poland
- Study start
- Jun 2006
- Primary completion
- Dec 2009 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 24 May 2010 (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.
The purpose of the study is to determine potential utility of renal fractional flow reserve in prognosis predicting after renal stent implantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypertensive patients | Experimental | Procedure: Renal artery stentingHypertensive patients with at least moderate renal artery stenosis |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At least moderate (60% or more) renal artery stenosis with atheromatic appearance in angiography
- Hypertension defined according to WHO criteria
- Age 18-75 years
- Signed informed consent obtained
Key exclusion criteria (8 listed)
- Bilateral renal artery stenosis or significant renal artery stenosis in solitary kidney
- Contraindications to percutaneous renal angioplasty with stenting
- Atrophy of the kidney supplied with stenosed artery
- Other well known secondary reason for hypertension
- Chronic heart failure NYHA II-IV
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 |
|---|---|---|
| Renal artery stenting | Procedure or surgery | Hypertensive patients |
Primary outcome
Blood pressure improvement
Time frame: 6 months
1 secondary outcome
Kidney function preservation
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2010.
- Derived from this study: PubMed 25268986Kadziela J, Prejbisz A, Michalowska I, Adamczak M, Warchol-Celinska E, Pregowska-Chwala B, Januszewicz M, Wiecek A, Januszewicz A, Witkowski A. Relationship between hemodynamic parameters of renal artery stenosis and the changes of kidney function after renal artery stenting in patients with hypertension and preserved renal function. Blood Press. 2015 Feb;24(1):30-4. doi: 10.3109/08037051.2014.958304. Epub 2014 Sep 30.
- Derived from this study: PubMed 23913461Kadziela J, Januszewicz A, Prejbisz A, Michalowska I, Januszewicz M, Florczak E, Kalinczuk L, Norwa-Otto B, Warchol E, Witkowski A. Prognostic value of renal fractional flow reserve in blood pressure response after renal artery stenting (PREFER study). Cardiol J. 2013;20(4):418-22. doi: 10.5603/CJ.2013.0101.
- Web page of Institute of Cardiology, WarsawLink provided by the sponsor.
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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.
Jacek Kadziela, MD,PhD principal investigator
National Institute of Cardiology, Warsaw, Poland
Adam Witkowski, Prof principal investigator
National Institute of Cardiology, Warsaw, Poland
Andrzej Januszewicz, Prof principal investigator
National Institute of Cardiology, Warsaw, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Renal artery stenting in people with Renal Artery Stenosis and Hypertension, run by National Institute of Cardiology, Warsaw, Poland at 1 site in Poland.
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 4 inclusion and 8 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: finished, as of the sponsor's last update on 24 May 2010. 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 Poland. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 improvement (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01128933, which also lists 2 linked publications.
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 May 2010.