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Phosphodiesterase Type-5 Inhibitor Therapy in Sickle Cell People With Pulmonary Hypertension

NCT03572036 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 38

Last updated 2021-04-19

No results posted yet for this 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.

Conditions

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    lead NIH

Principal Investigators

  • Swee Lay Thein, M.D. · National Heart, Lung, and Blood Institute (NHLBI)

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-20
Primary Completion
2021-04-16
Completion
2021-04-16

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03572036 on ClinicalTrials.gov