Sildenafil Therapy for Pulmonary Hypertension and Sickle Cell Disease
Public ClinicalTrials.gov record NCT00492531. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Treatment of Pulmonary Hypertension and Sickle Cell Disease With Sildenafil Therapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study will examine whether the drug sildenafil can lower blood pressure in the pulmonary artery (the blood vessel that leads from the heart to the lungs) in patients with sickle cell disease and pulmonary hypertension (high blood pressure in the lungs). It will see if this treatment can reduce disease complications, such as shortness of breath, pain crisis, pneumonia, and increase survival. Patients 12 years of age and older with sickle cell disease and pulmonary hypertension may be eligible for this study. Participants are randomly assigned to receive sildenafil or placebo (sugar pill) for 16 weeks. Before starting treatment, patients have baseline studies, including a pregnancy test for females of childbearing age; a chest x-ray; pulmonary function tests to measure how much air the patient can breathe in and out; an echocardiogram (heart ultrasound); a 6-minute walk test to measure exercise capacity; a quality-of-life assessment and a pain inventory. Patients with moderate to severe pulmonary hypertension undergo heart catheterization to evaluate the severity of hypertension before beginning sildenafil therapy. During treatment, patients are monitored with the following: * Blood tests: weeks 6, 10 and 16. * Echocardiogram: weeks 6 and 16. * 6-minute walk test: weeks 6, 10 and 16. * Measurements of weight, blood pressure and heart rate: weeks 6, 10 and 16. * Pregnancy test for women of childbearing age: weeks 6, 10 and 16. * Pain questionnaire once a day for a week: weeks 6 and 1.0 * Quality-of-life questionnaire: week 16. * Heart catheterization: week 16 for patients with moderate to severe hypertension. At the end of the 16-week period, patients may opt to continue to receive sildenafil and monitoring in an open-label phase of the study for up to 1 year.
Study identification
- NCT ID
- NCT00492531
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 74 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 12 Years to 70 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 31, 2007
- Primary completion
- Aug 31, 2009
- Completion
- Sep 30, 2009
- Last update posted
- Jan 5, 2016
2007 – 2009
United States locations
- U.S. sites
- 8
- U.S. states
- 7
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's Hospital, Oakland | Oakland | California | 94609 | — |
| University of Colorado | Denver | Colorado | 80220-3706 | — |
| Howard University Hospital | Washington D.C. | District of Columbia | 20060 | — |
| University of Illinois at Chicago | Chicago | Illinois | 60612 | — |
| Johns Hopkins University | Baltimore | Maryland | 21205 | — |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland | 20892 | — |
| Albert Einstein College of Medicine | The Bronx | New York | 10461 | — |
| Childrens Hospital, Pittsburgh | Pittsburgh | Pennsylvania | 15213-2583 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00492531, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 5, 2016 · Synced Sep 2, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00492531 live on ClinicalTrials.gov.