NCT00006173

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2000

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2000

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

August 11, 2000

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 14, 2000

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2004

Completed
Last Updated

March 4, 2008

Status Verified

January 1, 2004

First QC Date

August 11, 2000

Last Update Submit

March 3, 2008

Conditions

Keywords

AtherosclerosisHypertensionMagnetic Resonance Angiography

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • Pregnancy.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Warren G. Magnuson Clinical Center (CC)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Kulkarni S, O'Farrell I, Erasi M, Kochar MS. Stress and hypertension. WMJ. 1998 Dec;97(11):34-8.

    PMID: 9894438BACKGROUND
  • Bouyounes BT, Libertino JA. Renovascular hypertension. Curr Opin Urol. 1999 Mar;9(2):111-4. doi: 10.1097/00042307-199903000-00004.

    PMID: 10726080BACKGROUND
  • Taylor A. Radionuclide renography: a personal approach. Semin Nucl Med. 1999 Apr;29(2):102-27. doi: 10.1016/s0001-2998(99)80003-8.

    PMID: 10321824BACKGROUND

MeSH Terms

Conditions

Hypertension, RenovascularAtherosclerosisHypertension

Condition Hierarchy (Ancestors)

Hypertension, RenalKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesVascular DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive Diseases

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

August 11, 2000

First Posted

August 14, 2000

Study Start

August 1, 2000

Study Completion

January 1, 2004

Last Updated

March 4, 2008

Record last verified: 2004-01

Locations