Secondary Pulmonary Hypertension in Adults With Sickle Cell Anemia (NCT00011648) | Clinical Trial Compass
CompletedNot Applicable
Secondary Pulmonary Hypertension in Adults With Sickle Cell Anemia
United States986 participantsStarted 2008-02-19
Plain-language summary
The purpose of this study is to determine how often people with sickle cell anemia develop pulmonary hypertension a serious disease in which blood pressure in the artery to the lungs is elevated.
Men and women 18 years of age and older with sickle cell anemia may be eligible for this study. Participants will undergo an evaluation at Howard University s Comprehensive Sickle Cell Center in Washington, D.C. or at the National Institutes of Health in Bethesda, Maryland. It will include the following:
* medical history
* physical examination
* blood collection (no more than 50 ml., or about 1/3 cup) to confirm the diagnosis of sickle cell anemia, sickle cell trait or beta-thalassemia (Some blood will be stored for future research testing on sickle cell anemia.)
* echocardiogram (ultrasound test of the heart) to check the pumping action of the heart and the rate at which blood travels through the tricuspid valve.
Following this evaluation, a study nurse will contact participants twice a month for 2 months and then once every 3 months for the next 3 years for a telephone interview. The interview will include questions about general health and recent health-related events, such as hospitalizations or emergency room visits.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* INCLUSION CRITERIA FOR SICKLE CELL PATIENTS:
* Male and females over 18 years of age.
* Diagnosis of sickle cell disease (electrophoretic documentation of SS, SC, or S-beta thallassemia genotype is required).
EXCLUSION CRITERIA FOR SICKLE CELL PATIENTS:
* Hb A-only phenotype and sickle cell trait.
* Decisionally impaired subjects.
* Pregnant or lactating women
INCLUSION CRITERIA FOR CONTROL SUBJECTS:
* Male and females African American subjects over 18 years of age.
* Exclusion of sickle cell disease (electrophoretic documentation of hemoglobin A is required).
EXCLUSION CRITERIA FOR CONTROL SUBJECTS:
* Diagnosis of sickle cell disease (electrophoretic documentation of SS, or SC, or SB thallassemia genotype is required.)
* Decisionally impaired subjects.
* Pregnant or lactating women
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this study was focused on understanding how common pulmonary hypertension is in adults with sickle cell anemia and what the outlook tends to be, has my doctor seen the published findings, and do those results tell us anything meaningful about my own situation or prognosis?
2This trial is completed and was observational in nature — meaning it was studying the condition rather than testing a treatment — so what has my doctor learned from research like this that might actually change how they monitor or manage my care?
3Given that this study looked specifically at adults with sickle cell anemia, does my doctor think I should be screened for pulmonary hypertension, and how would that screening typically work in their practice?
4Since this trial measured prevalence and prognosis rather than testing a new drug or intervention, are there other active clinical trials my doctor knows about that are now testing actual treatments for pulmonary hypertension in people with sickle cell disease?
5Pulmonary hypertension can be a serious complication of sickle cell anemia — based on what research like this has shown about prognosis, what warning signs should I be watching for, and how often should I be evaluated for this condition?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To determine the prevalence and prognosis of secondary pulmonary hypertension in adult patients with sickle cell anemia.
Timeframe: 10 years
Trial details
NCT IDNCT00011648
SponsorNational Heart, Lung, and Blood Institute (NHLBI)