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Renal DiseasePhase 4NCT01545479

Increased Renal Oxygenation and Angiotensin Converting Enzyme Inhibition

A Phase 4 study testing captopril 25mg in people with Renal Disease, run by Instituto de Cardiologia do Rio Grande do Sul.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

It is well established that renal hypoxia is associated with the development of renal injury. The purpose of this study is measure the alterations in renal blood oxygenation after angiotensin II converting enzyme inhibition. Read more about this study

Who is it for?
Ages 45 to 55 years, women onlyHealthy volunteers can take part
Conditions the study is for
Renal Disease
What is being tested?
captopril 25mg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
No sites listed yet
Study dates
Jan 2010to Dec 2010
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 45 to 55 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • healthy female between 45 and 55 years

Who cannot join

  • man and
  • health female below 45 and above 55 years

About this study

Official title: Renal Oxygen Content is Increased in Healthy Subjects After Angiotensin Converting Enzyme Inhibition

It is well established that renal hypoxia is associated with the development of renal injury. The purpose of this study is measure the alterations in renal blood oxygenation after angiotensin II converting enzyme inhibition. The understanding of kidney adaptive mechanisms to renin angiotensin system effects in healthy subjects will be useful for the early detection of renal disease and for the development of new therapies to decrease the progression of the disease and its consequences.

Read the detailed description

Subjects The study will be conducted under a protocol (number 4111/08) approved by the Ethics Committee of the Instituto de Cardiologia do Rio Grande do Sul-Fundação Universitária de Cardiologia/Brazil. After giving their informed consent,the patients will participate in the study. None of the subjects will take medication,food and water overnight. All measurements will be performed at the end of the morning.

After control BOLD-MRI measurements acquisition, subjects will take an oral ACE inhibitor (captopril 25 mg). Thirty minutes after captopril administration, without moving from the scanner, blood pressure will be measured and a second BOLD acquisition will be performed to detect a possible alteration in the renal oxygenation. Data will be collected by two radiologists and interpreted by a physician and a physiologist.

MR Imaging Technique Images were acquired using 1.5T HDx (Sigma, GE Healthcare, Waukesha, Win) and an 8 channels body coil.

Localizer images will be performed with axial and sagittal planes following the long axis of both kidneys, using breath hold and fast spoiled gradient echo (FSPGR) technique.

Oblique axial and coronal reference images will be acquired for color maps following approximately the short and long axis of both kidneys using FSPGR with the following parameters: FOV=40cm, matrix 256x128, slice thickness=5cm, slice gap 6cm, 3 slices per plane in one breath hold. TR=150ms, TE=min full, FLIP=90, rBW=62KHz, 1NEX. This sequence provides an excellent contrast between cortex and medulla and avoid the unnecessary use of a contrast agents.

BOLD sensitive images will be acquired using the multiple echo FGRE sequence with the same geometrical parameters. The reference images considered will have the following parameters: TR = 60ms, FLIP=30, rBW=60KHz, 16 echoes from TE=2.1ms until 49.6ms, echo interval of 3.2ms, 1 NEX.

BOLD imaging Data Processing Bold image processing will be performed using the Function R2* module for R2*/T2* fitting, assuming single exponential decay without constant offset at AW4.3 (GE Healthcare).

For visualization and quantification, R2* parametric maps will be generated for each slice.(11, 18-19) A Puh Talium color table will be used, since it was a dynamic range with minimum value set at 7.0/sec and maximum value at 23/sec. Color will be ranged from blue to red, close to minimum R2* and below and close to maximum R2* and above, respectively. The green/yellow will be assumed as intermediate. When a position mismatch due to a different breath hold state, anatomical fat suppressed FSPGR images were used as transparent references over a parametric map or original BOLD images.

One slice out of three, which provided the best differentiation between cortex and medulla and minimum partial volume, will be selected for quantification. A total of 6 regions of interest (ROI) with a 9 pixel size were used, 3 positioned at the cortex and 3 at the medulla for each plane.

The ROIs will be positioned at the cortex according to the anatomical reference image (light gray) and blue on the parametric map. The ROIs will be positioned at the medulla using either the anatomical reference image (dark gray) or the parametric map that showed a green, yellow and red gradient (figure 1). Areas with susceptibility artifacts, such as bowel gas or areas with renal hilum vessels, will be avoided.

Data analysis The statistical analysis will be determined by variance test for three repeated measures (ANOVA). Data are presented as the mean ± SD. P<0.05 will be considered statistically significant.

Conditions
Renal Disease
Being tested
captopril 25mg
Keywords
ECA, BOLD-MRI, kidney
Medical subject headings
Kidney Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • captopril 25mgDrug

    Also called BOLD-MRI

    renal blood oxygenation after captopril

Study groups in NCT01545479
Study groupRoleWhat they receive
Captopril 25mgOtherTo study the renal blood oxygenation, the subjects took captopril (25mg).
Receives: Drug: captopril 25mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Measure the renal blood oxigenation after angiotensin converting enzyme inhibition

    Measured: up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2012 (estimated)
  2. Study startJan 2010
  3. Primary completionOct 2010
  4. Study completionDec 2010

Resources

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
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01545479
Sponsor's protocol ID
4111/08
Status last verified
Mar 2012
First submitted
16 Jan 2012
Last updated
6 Mar 2012
Results posted
No
Data monitoring committee
No

Publications

  • Stein A, Goldmeier S, Voltolini S, Setogutti E, Feldman C, Figueiredo E, Eick R, Irigoyen M, Rigatto K. Renal oxygen content is increased in healthy subjects after angiotensin-converting enzyme inhibition. Clinics (Sao Paulo). 2012 Jul;67(7):761-5. doi: 10.6061/clinics/2012(07)10.

    PubMed 22892920

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing captopril 25mg in people with Renal Disease, run by Instituto de Cardiologia do Rio Grande do Sul.

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: finished, as of the sponsor's last update on 6 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.

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?

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?

Measure the renal blood oxigenation after angiotensin converting enzyme inhibition (time frame: up to 12 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 NCT01545479, which also lists 1 linked publication.

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 6 Mar 2012; AzTrials last refreshed its copy on 7 Nov 2026.

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