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NCT03572036
Phosphodiesterase Type-5 Inhibitor Therapy in Sickle Cell People With Pulmonary Hypertension
trial in Pulmonary Hypertension in 38 participants. Completed in 16 April 2021.
16 April 2021
Quick facts
| Lead sponsor | National Heart, Lung, and Blood Institute (NHLBI) |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 38 |
| Start date | 20 June 2018 |
| Primary completion | 16 April 2021 |
| Estimated completion | 16 April 2021 |
| Sites | 1 location across United States |
Conditions studied
- Pulmonary Hypertension — all drugs for Pulmonary Hypertension →
- Sickle Cell Disease — all drugs for Sickle Cell Disease →
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Who can join
Adults 18 to 99, any sex, with Pulmonary Hypertension or Sickle Cell Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03572036
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Pulmonary Hypertension
Currently open trials in the same condition.
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- NCT07073820 — A Study to Learn About the Study Medicine (Called PF-07868489) in People With Pulmonary Arterial Hypertension Who Have P · Phase 2 · recruiting
- NCT06351345 — 129 Xenon Imaging in Patients Treated With Sotatercept · Phase 2 · recruiting
- NCT07187206 — Safety and Efficacy of FETO in CDH Phase III · Phase 3 · recruiting
- NCT07206173 — Londrina Activities of Daily Living Protocol in Pulmonary Hypertension · recruiting
Other National Heart, Lung, and Blood Institute (NHLBI) trials
Trials by the same sponsor.
- NCT07566494 — Escalating Doses of VAS-101 in Subjects With Stable Sickle Cell Disease · Phase 1 · not yet recruiting
- NCT07137455 — EDEN Intracardiac Electrogram Recording and Classifying System · NA · enrolling by invitation
- NCT05372627 — NHLBI-Emory Advanced Cardiac CT Reconstruction · not yet recruiting
- NCT07516379 — GRAfT 2.0. A Multimodal Prospective Approach to Define the Mechanisms and Clinical Features of Acute and Chronic Rejecti · not yet recruiting
- NCT06948097 — Syk Inhibition in MItigating Lung Allograft Rejection (SIMILAR): A Trial to Evaluate the Safety and Tolerability of Fost · Phase 1 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03572036 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Heart, Lung, and Blood Institute (NHLBI)
- Last refreshed: 19 April 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03572036.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing