View Clinical Trial (Medical Research Study)
Phase 2 Trial for Glutamine Therapy for Hemolysis-Associated Pulmonary Hypertension
| City: |
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Oakland |
| State: |
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California |
| Zip Code: |
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94608 |
| Conditions: |
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Pulmonary Hypertension - Sickle Cell Disease - Thalassemia |
| Purpose: |
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The primary hypothesis of this study is that glutamine supplementation will improve the
erythrocyte glutamine/glutamate ratio, a biomarker of oxidative stress, hemolysis and
pulmonary hypertension (PH) in sickle cell disease (SCD) and thalassemia (Thal) patients
with PH. PH is defined as a tricuspid regurgitant jet velocity (TRV) on Doppler
echocardiography > 2.5 m/s. We also predict that glutamine therapy will increase arginine
bioavailability and subsequently alter sickle red cell endothelial interaction that can be
identified using endo-PAT technology through nitric oxide (NO) generation, leading to
changes in biological markers, and clinical outcome. Specifically our second hypothesis is
that oral glutamine will decrease biomarkers of hemolysis and adhesion molecules, and
improve the imbalanced arginine-to-ornithine ratio that occurs in hemolytic anemias, leading
to improved arginine bioavailability and clinical endpoints of endothelial dysfunction and
PH in patients with SCD and Thal.
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
- Established diagnosis of SCD (Hb SS, SC or SBeta- thalassemia) or Thal
- PH documented by echocardiography, defined as at TRV greater than 2.5 m/s
- Age greater than or equal to 4 years
Exclusion Criteria:
- Inability to take or tolerate oral medication
- Acute crisis or hospitalization within 1 month of enrollment
- Hepatic dysfunction (SGPT greater than 3X normal)
- Renal dysfunction (Creatinine greater than 2X normal)
- Allergy to glutamine
- Pregnancy or breastfeeding
- Patients on sildenafil (Viagra), calcium channel blockers, or amino acid/protein
supplements (other therapies acceptable if stable more than 3 months)
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| NCT ID: |
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NCT01048905 |
| Primary Contact: |
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Principal Investigator
Claudia Morris, MD
Emory University
Melinee Stewart
Phone: 510-428-3885 ext. 2858
Email: Mstewart@mail.cho.org
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| Backup Contact: |
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Email: LLavrisha@mail.cho.org
Lisa Lavrisha, NP
Phone: 510-428-3885 ext. 4376
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| Location Contact: |
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Oakland, California 94608
United States
Melinee Stewart
Phone: 510-428-3885
Email: Mstewart@mail.cho.org
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 18, 2013 |
| Modifications to this listing: |
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