Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:43 AM
Ignite Modification Date:
2025-12-25 @ 3:43 AM
NCT ID:
NCT01036802
Eligibility Criteria:
Inclusion Criteria:
* At least 16 years of age
* Have a confirmed diagnosis of sickle cell anemia (HbSS) or sickle cell beta zero thalassemia
* Have evidence of persistent elevation of pulmonary artery systolic pressure on Doppler echocardiography (TR jet velocity of 2.5 to 2.9 m/s \[or estimated pulmonary artery systolic pressure above the upper limit of reference adjusted ranges and up to 45 mm Hg\]), but no evidence of moderate or severe diastolic dysfunction on tissue Doppler echocardiography. Mild PHT must be confirmed on repeat evaluation, at least 3 months later
* Have a serum creatinine =/\< 1.5 mg/dl
* Have serum transaminase values (ALT) \< 2 times upper limits of normal
* Have serum albumin =/\> 3.2 g/dl
* Have a platelet count =/\< 150,000 cu/mm
* Have normal baseline coagulation profile (PT/PTT)
* Patients on treatment with hydroxyurea should be on a stable dose for at least 6 months. Doses of hydroxyurea may only be adjusted during the course of the study for safety reasons.
* Be able to understand the requirements of the study and be willing to give informed consent.
* Women of childbearing age must be practicing (and will continue to practice for the course of the study) an adequate method of contraception.
Exclusion Criteria:
* Have a baseline hemoglobin \< 6.0 gm/dl
* Have congenital heart disease, valvular heart disease, and other identified cause of pulmonary hypertension (including pulmonary fibrosis) unrelated to SCD
* Have an elevated pulmonary capillary wedge pressure, as evidenced by E/Em \> 15 by pulsed wave and tissue Doppler imaging
* Have no measurable tricuspid regurgitant velocity on echocardiography
* Have a history of major gastrointestinal bleeding or a bleeding diathesis
* Have sickle cell complications such as recent vaso-occlusive crisis or acute chest syndrome, 4-weeks prior to commencing the study
* Have a history of clinically overt stroke(s) or seizures
* Have a brain magnetic resonance imaging/magnetic resonance angiography scan with evidence of Moya Moya within the preceding year
* Are pregnant or breastfeeding
* Are on chronic anticoagulant therapy
* Have a history of metastatic cancer
* Are chronically on therapy with aspirin or non-steroidal anti-inflammatory agents
* Are on a chronic transfusion program or have received a blood transfusion in the prior 8 weeks
* Have a positive urine toxicology screen for cocaine and amphetamines
* Have a history of alcohol abuse
* Are currently receiving treatment with epoprostenol (or similar prostacyclin analog), sildenafil (or similar phosphodiesterase 5 inhibitor), bosentan or arginine
* Have ingested any investigational drugs within the past 4 weeks.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
65 Years
Study:
NCT01036802
Study Brief:
Protocol Section:
NCT01036802