HealthyNCT00006173
Magnetic Resonance Imaging for Evaluating Kidney Function
An observational study of Healthy and Renovascular Hypertension, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial summary
Renovascular hypertension (RVH) is a potentially curable disease affecting 0.5-5 percent of patients with hypertension. The current diagnostic work-up of RVH involves a complex algorithm which includes doppler ultrasound, captopril renography and conventional angiography. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy, Renovascular Hypertension
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2000to Jan 2004
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Healthy volunteers or patients with significant clinical suspicion of renovascular hypertension.
- Subjects able to understand the informed consent for this study.
- Subjects must be able to hold their breath for 20 second intervals.
- Patients must be clinically stable and be judged by their physician able to tolerate the MR study of 1.5-2 hour duration.
Who cannot join
- Any contraindication for MR study including: pacemaker or other implanted electronic device; cochlear implants; metal in the eye; embedded shrapnel fragments; cerebral aneurysm clips; or medical infusion pumps.
- Allergy to gadolinium, iodinated contrast media, ACEIs, or sulphur-containing medication.
- Patients have a hematocrit at or below 30. Severe anemia may predispose to hypotension after captopril.
- Patients with hyperkalemia (plasma potassium: above 5.0 mmol/L), because of the risk of arrhythmia.
- Clinically unstable patients and those unable to tolerate a 1-2 hour MR study. Examples of medical conditions that would lead to exclusion include unstable angina, dyspnea at rest, severe pain at rest, or severe back pain.
- Pregnancy.
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- Nursing mothers.
- Subjects who are claustrophobic and are unable to tolerate MR imaging.
- Patients with a serum creatinine concentration above 4mg/dl.
- Bilateral renal stents.
- Healthy subjects must not have an abnormality detected on dipstick urinalysis, or a systolic BP above 140 mmHg or a diastolic BP above 90 mmHg on screening examination or an abnormal BUN or creatinine level in the blood.
Trial locations and contacts
1 site in 1 country.
United States1 site
Warren G. Magnuson Clinical Center (CC)
Bethesda, Maryland, 20892
About this study
Official title: Assessment of Renal Artery Stenosis and Renovascular Hypertension by Contrast Enhanced Magnetic Resonance Imaging: A Pilot Study
Renovascular hypertension (RVH) is a potentially curable disease affecting 0.5-5 percent of patients with hypertension. The current diagnostic work-up of RVH involves a complex algorithm which includes doppler ultrasound, captopril renography and conventional angiography. Because of the expense, risk and inconvenience of this workup, patients may not be correctly diagnosed.
Advances in MR technology present the opportunity to develop a single comprehensive test. This would combine an MR angiogram that provides anatomic information about the renal arteries, and an MR renogram that provides information about the functional impact of a stenosis as a cause of hypertension. Our main purpose is to test MR renography with and without an oral angiotensin converting enzyme inhibitor (ACEI) combined with MR angiography against the reference standard of captopril radionuclide renography. Secondary goals of this study are to test whether hypoxia within ischemic kidneys affected by RVH is detectable by T2 weighted (Blood oxygen level dependent or BOLD) MRI. This is considered of value since such a test of oxygenation would further shorten and simplify the diagnostic MR test. Information gained from this study could lead to important changes in the diagnostic and pathophysiologic understanding of RVH.
Read the detailed description
Renovascular hypertension (RVH) is a potentially curable disease affecting 0.5-5% of patients with hypertension. The current diagnostic work-up of RVH involves a complex algorithm which includes doppler ultrasound, captopril renography and conventional angiography. Because of the expense, risk and inconvenience of this workup, patients may not be correctly diagnosed.
Advances in MR technology present the opportunity to develop a single comprehensive test. This would combine an MR angiogram that provides anatomic information about the renal arteries, and an MR renogram that provides information about the functional impact of a stenosis as a cause of hypertension. Our main purpose is to test MR renography with and without an oral angiotensin converting enzyme inhibitor (ACEI) combined with MR angiography against the reference standard of captopril radionuclide renography. Secondary goals of this study are to test whether hypoxia within ischemic kidneys affected by RVH is detectable by T2* weighted (Blood oxygen level dependent or BOLD) MRI. This is considered of value since such a test of oxygenation would further shorten and simplify the diagnostic MR test. Information gained from this study could lead to important changes in the diagnosis and pathophysiologic understanding of RVH.
- Conditions
- Healthy, Renovascular Hypertension
- Keywords
- Atherosclerosis, Hypertension, Magnetic Resonance Angiography
- Medical subject headings
- Hypertension, Renovascular, Atherosclerosis, Hypertension
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2000 (estimated)
- Study startAug 2000
- Study completionJan 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Observational
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006173
- Sponsor's protocol ID
- 000195
- Other IDs
- 00-CC-0195
- Status last verified
- Jan 2004
- First submitted
- 11 Aug 2000
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Kulkarni S, O'Farrell I, Erasi M, Kochar MS. Stress and hypertension. WMJ. 1998 Dec;97(11):34-8.
PubMed 9894438Bouyounes BT, Libertino JA. Renovascular hypertension. Curr Opin Urol. 1999 Mar;9(2):111-4. doi: 10.1097/00042307-199903000-00004.
PubMed 10726080Taylor A. Radionuclide renography: a personal approach. Semin Nucl Med. 1999 Apr;29(2):102-27. doi: 10.1016/s0001-2998(99)80003-8.
PubMed 10321824
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Renal Artery Stenosis and Renovascular Hypertension by Contrast Enhanced Magnetic Resonance Imaging: A Pilot Study
- ClinicalTrials.gov ID
- NCT00006173
- Acronym / sponsor ID
- 000195
- Conditions
- Healthy, Renovascular Hypertension
- Keywords
- Atherosclerosis, Hypertension, Magnetic Resonance Angiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- Aug 2000
- Study completion
- Jan 2004
- First posted
- 14 Aug 2000 (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.
Renovascular hypertension (RVH) is a potentially curable disease affecting 0.5-5 percent of patients with hypertension. The current diagnostic work-up of RVH involves a complex algorithm which includes doppler ultrasound, captopril renography and conventional angiography. Because of the expense, risk and inconvenience of this workup, patients may not be correctly diagnosed.
Advances in MR technology present the opportunity to develop a single comprehensive test. This would combine an MR angiogram that provides anatomic information about the renal arteries, and an MR renogram that provides information about the functional impact of a stenosis as a cause of hypertension. Our main purpose is to test MR renography with and without an oral angiotensin converting enzyme inhibitor (ACEI) combined with MR angiography against the reference standard of captopril radionuclide renography. Secondary goals of this study are to test whether hypoxia within ischemic kidneys affected by RVH is detectable by T2 weighted (Blood oxygen level dependent or BOLD) MRI. This is considered of value since such a test of oxygenation would further shorten and simplify the diagnostic MR test. Information gained from this study could lead to important changes in the diagnostic and pathophysiologic understanding of RVH.
Detailed description
Renovascular hypertension (RVH) is a potentially curable disease affecting 0.5-5% of patients with hypertension. The current diagnostic work-up of RVH involves a complex algorithm which includes doppler ultrasound, captopril renography and conventional angiography. Because of the expense, risk and inconvenience of this workup, patients may not be correctly diagnosed.
Advances in MR technology present the opportunity to develop a single comprehensive test. This would combine an MR angiogram that provides anatomic information about the renal arteries, and an MR renogram that provides information about the functional impact of a stenosis as a cause of hypertension. Our main purpose is to test MR renography with and without an oral angiotensin converting enzyme inhibitor (ACEI) combined with MR angiography against the reference standard of captopril radionuclide renography. Secondary goals of this study are to test whether hypoxia within ischemic kidneys affected by RVH is detectable by T2* weighted (Blood oxygen level dependent or BOLD) MRI. This is considered of value since such a test of oxygenation would further shorten and simplify the diagnostic MR test. Information gained from this study could lead to important changes in the diagnosis and pathophysiologic understanding of RVH.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy volunteers or patients with significant clinical suspicion of renovascular hypertension.
- Subjects able to understand the informed consent for this study.
- Subjects must be able to hold their breath for 20 second intervals.
- Patients must be clinically stable and be judged by their physician able to tolerate the MR study of 1.5-2 hour duration.
Key exclusion criteria (11 listed)
- Any contraindication for MR study including: pacemaker or other implanted electronic device; cochlear implants; metal in the eye; embedded shrapnel fragments; cerebral aneurysm clips; or medical infusion pumps.
- Allergy to gadolinium, iodinated contrast media, ACEIs, or sulphur-containing medication.
- Patients have a hematocrit at or below 30. Severe anemia may predispose to hypotension after captopril.
- Patients with hyperkalemia (plasma potassium: above 5.0 mmol/L), because of the risk of arrhythmia.
- Clinically unstable patients and those unable to tolerate a 1-2 hour MR study. Examples of medical conditions that would lead to exclusion include unstable angina, dyspnea at rest, severe pain at rest, or severe back pain.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 4 Mar 2008.
- Background: PubMed 9894438Kulkarni S, O'Farrell I, Erasi M, Kochar MS. Stress and hypertension. WMJ. 1998 Dec;97(11):34-8.
- Background: PubMed 10726080Bouyounes BT, Libertino JA. Renovascular hypertension. Curr Opin Urol. 1999 Mar;9(2):111-4. doi: 10.1097/00042307-199903000-00004.
- Background: PubMed 10321824Taylor A. Radionuclide renography: a personal approach. Semin Nucl Med. 1999 Apr;29(2):102-27. doi: 10.1016/s0001-2998(99)80003-8.
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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?
An observational study of Healthy and Renovascular Hypertension, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
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 11 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 4 Mar 2008. 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 United States. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00006173, which also lists 3 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 4 Mar 2008.