HypertensionNCT00470769
The Efficacy of Color-Doppler Ultrasonography to Assess the Renal Blood Flow With the Estimation of GFR
An observational study of Hypertension and Renal Failure, run by University of Roma La Sapienza at 3 sites in Italy.
Trial summary
It is generally assumed that renal blood flow is symmetric in the absence of renal artery stenosis. The importance of studying the function of both kidneys separately is because it cannot be assumed that they are functionally equal.The aim of the present study is to evaluate whether this is really in patients with… Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Renal Failure
- What is being tested?
- Color-Doppler Ultrasound, 99mTc-DTPA scintigraphy
- Type of treatment
- Surgery or procedure
- How many people
- 2,006 participants
- Where
- 3 sitesItaly
- Study dates
- Sep 2006to May 2007
- Phase
- Observational
- 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 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with hypertension
- Patients with moderate renal insufficiency
- Normal subjects
Who cannot join
- Patients with solitary kidney function
- Patients with renal artery stenosis
- Patients underwent renal angioplasty and stenting
Trial locations and contacts
3 sites in 1 country.
Italy3 sites, 3 recruiting
- Recruiting
Giorgio Fuiano
Catanzaro, 88020
- Recruiting
University of Rome La Sapienza
Roma, 00100
Rosario Cianci, MD, +39335206441, ciancirosario@tin.it
Giorgio Fuiano, MD, +39 0961775360, gfuiano@libero.it
- Recruiting
Rosario Cianci
Rome, 00100
About this study
Official title: Color-Doppler Ultrasonography vs 99mTc-DTPA Scintigraphy to Assess the Renal Blood Flow
It is generally assumed that renal blood flow is symmetric in the absence of renal artery stenosis. The importance of studying the function of both kidneys separately is because it cannot be assumed that they are functionally equal.The aim of the present study is to evaluate whether this is really in patients with essential hypertension and/or moderate kidneys loss.
Read the detailed description
To validate color Doppler ultrasonography of renal arteries for the assessment of renal blood flow (RBF), we comparing left and right RBF estimates and their sum (total RBF) by echo-Doppler with data obtained by 99mTc-DTPA scintigraphy in 50 patients with hypertension and/or moderate renal failure, compared with 30 normal control subjects.
- Conditions
- Hypertension, Renal Failure
- Being tested
- Color-Doppler Ultrasound, 99mTc-DTPA scintigraphy
- Keywords
- Color-Doppler Ultrasonography, Renal scintigraphy, Kidney failure, GFR
- Medical subject headings
- Hypertension, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Color-Doppler Ultrasound, 99mTc-DTPA scintigraphyProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2007 (estimated)
- Study startSep 2006
- Study completionMay 2007 (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.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Defined population
- Time perspective
- Other
- Enrolment
- 2,006 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Investigators
- Rosario Cianci, MD, Principal investigator, Department Of Clinic Medicine, Chair of NephrologyGiorgio Fuiano, MD, Study director, University of Catanzaro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00470769
- Sponsor's protocol ID
- CR-UR-00001
- Status last verified
- May 2007
- First submitted
- 7 May 2007
- Last updated
- 8 May 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Color-Doppler Ultrasonography vs 99mTc-DTPA Scintigraphy to Assess the Renal Blood Flow
- ClinicalTrials.gov ID
- NCT00470769
- Acronym / sponsor ID
- CR-UR-00001
- Conditions
- Hypertension, Renal Failure
- Keywords
- Color-Doppler Ultrasonography, Renal scintigraphy, Kidney failure, GFR
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,006 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- Sep 2006
- Study completion
- May 2007 (estimated)
- First posted
- 8 May 2007 (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.
It is generally assumed that renal blood flow is symmetric in the absence of renal artery stenosis. The importance of studying the function of both kidneys separately is because it cannot be assumed that they are functionally equal.The aim of the present study is to evaluate whether this is really in patients with essential hypertension and/or moderate kidneys loss.
Detailed description
To validate color Doppler ultrasonography of renal arteries for the assessment of renal blood flow (RBF), we comparing left and right RBF estimates and their sum (total RBF) by echo-Doppler with data obtained by 99mTc-DTPA scintigraphy in 50 patients with hypertension and/or moderate renal failure, compared with 30 normal control subjects.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with hypertension
- Patients with moderate renal insufficiency
- Normal subjects
Key exclusion criteria (3 listed)
- Patients with solitary kidney function
- Patients with renal artery stenosis
- Patients underwent renal angioplasty and stenting
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 |
|---|---|---|
| Color-Doppler Ultrasound, 99mTc-DTPA scintigraphy | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2007.
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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.
Rosario Cianci, MD principal investigator
Department Of Clinic Medicine, Chair of Nephrology
Giorgio Fuiano, MD study director
University of Catanzaro
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension and Renal Failure, run by University of Roma La Sapienza at 3 sites in Italy.
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 3 inclusion and 3 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 8 May 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rosario Cianci, MD (+39335206441, ciancirosario@tin.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 8 May 2007.