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NCT03572036 · ClinicalTrials.gov registry record
Phosphodiesterase Type-5 Inhibitor Therapy in Sickle Cell People With Pulmonary Hypertension
A clinical trial, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- 38
- Enrollment target
NCT03572036: Completed study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
NCT03572036 is a clinical trial that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 38 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03572036 has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- 38 participants
- Enrollment target
Study Summary
Background: Sickle cell disease (SCD) is a common inherited blood disorder. Many people with SCD are at risk to get pulmonary hypertension (PH). PH means that the blood pressure in the blood vessels to the lungs is high, and is a serious disease and. Very few studies have looked at the success of treatments for PH in people with SCD. Researchers want to learn more about treating PH with a type of drug called phosphodiesterase type 5 inhibitors (PDE5-I). They will look at the records of people who have already joined other studies. Objective: To identify people who already joined NIH SCD protocols whose medical records should be reviewed. The review will look at the description of SCD patients with PH who have already taken PDE5-I and the outcomes for these people. Eligibility: Adults ages 18 and older with SCD and PH. They must have joined certain NIH studies and taken PDE5-I therapy for at least 16 weeks. Design: This study is a review of medical records. Researchers will collect data from databases of existing studies. They will identify people in those studies who have SCD and PH and took the study drug for at least 16 weeks. Researchers will review the full medical records of those people. From that review, researchers will find participants who meet the inclusion criteria. They will extract data from those records. Researchers will analyze the data. This includes results from heart and lung tests, imaging, and walking tests. It will also include results of a procedure called right heart catheterization. Demographic data and lab data will also be collected. Researchers will remove identifying information from the data, then share it in a database.
Primary Outcome
We hypothesize that there are some subjects, for example those with RHC-defined PH, with particular characteristics who may benefit from improved morbidity and mortality with the use of long- term PDE5-I therapy.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2018-06-20 |
| Est. Completion | 2021-04-16 |
What the finished NCT03572036 record still lists
NCT03572036 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 38 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT03572036 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03572036 about?
NCT03572036 is a clinical study titled "Phosphodiesterase Type-5 Inhibitor Therapy in Sickle Cell People With Pulmonary Hypertension". Background: Sickle cell disease (SCD) is a common inherited blood disorder. Many people with SCD are at risk to get pulmonary hypertension (PH). PH means that the blood pressure in the blood vessels to the lungs is high, and is a serious disease and. Very few studies have looked at the success of t...
What is the current status of trial NCT03572036?
This trial is currently completed. The enrollment target is 38 participants. The study started on 2018-06-20. Estimated completion is 2021-04-16.
Who is sponsoring clinical trial NCT03572036?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
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