Status:
COMPLETED
Therapeutic Application of Intravascular Nitrite for Sickle Cell Disease
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Sickle Cell Anemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study examines ways in which nitric oxide (NO), an important molecule that controls how blood flows through the body's vessels, might be restored with a compound called sodium nitrite. It is hope...
Detailed Description
Sickle cell disease is an autosomal recessive disorder and the most common genetic disease affecting African-Americans. Approximately 0.15% of African-Americans are homozygous for sickle cell disease,...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Must be at least 18 years of age
- Homozygous sickle cell disease or S beta-0-thalassemia/alpha-thalassemia
- Provides informed, written consent for participation
- EXCLUSION CRITERIA:
- Patients with currently uncontrolled hypertension (diastolic blood pressures greater than 95 mmHg)
- Hypercholesterolemia (LDL cholesterol greater than 130 mg/dL)
- Diabetes mellitus (fasting blood glucose greater than 120 mg/dL)
- Smoking within one month
- Dietary ingestions of herbal medications, alcohol or caffeine within 12 hours of the study
- Arteriosclerotic cardiovascular disease
- Peripheral arteriosclerotic vascular disease
- Treatment within the last 14 days with sildenafil, vardenafil, tadalafil, inhaled nitric oxide, nitroglycerin or other NO-dependent drugs, such as arginine
- Red cell G6PD activity below normal range (All subjects will be tested for red blood cell G6PD deficiency; levels below the lower limits of normal will result in exclusion from participation in the study)
- Cytochrome B5 deficiency
- History of reaction to a medication or other substance characterized by dyspnea and cyanosis
- Lactating females (Lactating females will not participate since nitrites cross into breast milk and could cause methemoglobinemia in the infant)
- Pregnancy testing (urine or blood) will be required of all women of reproductive age to exclude current pregnancy
Exclusion
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 24 2007
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00095472
Start Date
November 1 2004
End Date
August 24 2007
Last Update
November 5 2019
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892