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Pulmonary Hypertension SOLAR

Study acronym: PH SOLAR
StatusRecruiting
PhasePhase 2
Started2023-11-08
View on ClinicalTrials.gov ↗

Amendment history

2026-02-23
minor
Study Status, Oversight v19
Primary completion date2025-12-30→2027-07-31
Completion date2025-12-30→2028-07-31
2025-10-17
minor
Study Status, Contacts/Locations v18
Study sitescontacts updated at 1 of 1 site
2025-01-17
minor
Study Status, Oversight, Contacts/Locations v17
Primary completion date2024-12-30→2025-12-30
Completion date2024-12-30→2025-12-30
Study sitescontacts updated at 1 of 1 site
2024-07-15
minor
Study Status, Outcome Measures v16
Re-verified, no change to tracked fields
2024-01-16
minor
Study Status v15
Primary completion date2023-12-30→2024-12-30
Completion date2023-12-30→2024-12-30
Show 14 earlier versions
2023-12-15
minor
Study Status v14
Start dateestimated 2023-11-15→confirmed 2023-11-08
2023-10-20
minor
Study Status v13
Start date2023-09-15→2023-11-15
2023-06-23
minor
Study Status v12
Primary completion date2023-08-30→2023-12-30
Completion date2023-08-30→2023-12-30
Start date2023-05-15→2023-09-15
2023-04-10
minor
Study Status v11
Start date2023-02-15→2023-05-15
2023-01-23
minor
Study Status v10
Start date2022-12-15→2023-02-15
2022-10-05
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v9
Trial statusNot Yet Recruiting→Recruiting
Study sitesdetails revised at 1 of 1 site
2022-10-04
minor
Study Status v8
Start date2022-08-15→2022-12-15
2022-05-03
minor
Study Status v7
Primary completion date2023-10-30→2023-08-30
Completion date2023-10-30→2023-08-30
Start date2022-02-15→2022-08-15
2022-01-14
minor
Study Status v6
Start date2021-12-01→2022-02-15
2021-10-27
minor
Study Status v5
Start date2021-10-01→2021-12-01
2021-07-27
minor
Study Status v4
Primary completion date2023-06-30→2023-10-30
Completion date2023-06-30→2023-10-30
Start date2021-07-01→2021-10-01
2021-05-25
minor
Study Status v3
Start date2021-05-01→2021-07-01
2021-03-11
minor
Study Status, Study Description, Arms and Interventions, Eligibility v2
Study description-4 characters
[...] nder phenotypes when treated with PAH-specific therapies. In our preliminary studies of subjects treated with Tyvaso, The st [...]
2021-03-02
minor
Study Status, Study Description, Study Design v1
Study description-234 characters
[...] ial responders vs non-responders to PAH-specific therapies. OurThe central hypothesis is that similar mechanisms and pathways underlie pulmonary vascular remodeling in IPF-PH, COPD-PH, and PAH. However, only a subset of Group 3 PH patients disp [...] In our preliminary studies of subjects treated with Tyvaso, weThe havestudy team has observed distinct 129Xe MRI signatures at baseline and with [...] function. Consistent with this, recent studies using single-cell RNA sequencing (scRNAseq) of the pulmonary vasculature [...] ve demonstrated changes consistent with vascular remodeling. By taking advantage of the act [...]
2021-02-26
minor
Original filing
1,786 trials monitored
See 77 trials at risk
1,057 trials monitored
See 28 trials at risk
The main goal of this study is to develop a noninvasive signature for pulmonary vascular remodeling in Group 3 PH patients, using hyperpolarized 129Xe magnetic resonance imaging (129Xe MRI). Such a signature may identify Group 3 PH responders to PAH-specific therapies. PAH's unique 129Xe MRI signature has been shown in previous studies. Past studies have lacked a pathologic "ground truth" correlate of these signatures, which could be provided by comparing them with the pathology of lung explant tissue from patients who have undergone a lung transplant. This signature could be validated in a cohort of patients with Group 3 PH in future studies.
Trial Details
NCT Number NCT04778046
Lead Sponsor Bastiaan Driehuys
Conditions Interstitial Lung Disease, COPD, Pulmonary Arterial Hypertension
Enrollment 30 participants
Start Date 2023-11-08
Primary Completion 2027-07-31 (estimated)
Study Completion 2028-07-31 (estimated)
Updated on ClinicalTrials.gov 2026-02-24