Ignite Creation Date:
2024-05-06 @ 2:44 PM
Last Modification Date:
2024-10-26 @ 1:36 PM
Study NCT ID:
NCT04416750
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-10-10
First Post:
2020-05-28
Brief Title:
Positioning Imatinib for Pulmonary Arterial Hypertension
Sponsor:
Imperial College London
Organization:
Imperial College London
Study Overview
Official Title:
Positioning Imatinib for Pulmonary Arterial Hypertension
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PIPAH
Brief Summary:
Pulmonary Arterial Hypertension PAH is a rare condition in which a narrowing of blood vessels carrying blood through the lungs puts an increased work load on the heart it has to work harder to pump blood through the lungs While current treatments relieve some of the symptoms they do not stop or reverse the disease in the affected blood vessels Imatinib is a medicine licensed for some types of cancers A published study has shown that imatinib can have beneficial effects on blood flow through the lungs and exercise capacity in patients with PAH even when added to existing treatments However there have been concerns about its safety and tolerability Imatinib continues to be prescribed occasionally on compassionate grounds usually when other treatment options have been exhausted and some patients feel better on the drug To improve the investigators understanding the investigators of this study re-visits the use of Imatinib as a potential treatment for patients with PAH
Detailed Description:
What does the study involve
The study involves treatment of PAH patients with imatinib study drug for up to 24 weeks and clinical assessments and tests to assess the drugs safety and tolerability
PAH patients will be seen at their local hospital by the PAH clinical research team Before someone can start study the study doctor or clinical study team will describe the clinical trial in detail If a potential subject decides to participate heshe will be asked to sign the informed consent form before any study procedures are done
Participants will be asked to come to their local hospital for clinical appointments This includes a screening visit a baseline visit three clinical assessments and an end-of-study visit In between and at the very end of these there will be six tele-visits assessments over the phone Each clinical appointment will be on a weekday morning or afternoon No major lifestyle restrictions are required for these appointments
Participants will undergo clinical examinations and tests to monitor the severity of PAH and the response to the study drug Clinical procedures include
Questions about demographics medical and medication history
Physical examination and record of vital signs blood pressure temperature heart and respiratory rate
Questionnaire about quality of life
Assessments of PAH severity WHO Functional Class six-minute walk test and Borg dyspnoea index
Right heart catheterisation to assess response to the drug
Haematology and clinical chemistry blood tests to ensure safety
Serum pregnancy test and urine pregnancy tests if applicable to exclude pregnancy
Blood samples to measure the levels of the study drug in the circulation
Additional blood samples for future research on PAH andor the mechanism of action of the drug
Electrocardiogram ECG and echocardiogram to assess the size shape pumping action and the extent of any damage to the heart
Brain MRI scan or CT scan if MR is not indicatedtolerated to exclude bleeding in the brain
The study involves treatment of PAH patients with imatinib study drug for up to 24 weeks and clinical assessments and tests to assess the drugs safety and tolerability
PAH patients will be seen at their local hospital by the PAH clinical research team Before someone can start study the study doctor or clinical study team will describe the clinical trial in detail If a potential subject decides to participate heshe will be asked to sign the informed consent form before any study procedures are done
Participants will be asked to come to their local hospital for clinical appointments This includes a screening visit a baseline visit three clinical assessments and an end-of-study visit In between and at the very end of these there will be six tele-visits assessments over the phone Each clinical appointment will be on a weekday morning or afternoon No major lifestyle restrictions are required for these appointments
Participants will undergo clinical examinations and tests to monitor the severity of PAH and the response to the study drug Clinical procedures include
Questions about demographics medical and medication history
Physical examination and record of vital signs blood pressure temperature heart and respiratory rate
Questionnaire about quality of life
Assessments of PAH severity WHO Functional Class six-minute walk test and Borg dyspnoea index
Right heart catheterisation to assess response to the drug
Haematology and clinical chemistry blood tests to ensure safety
Serum pregnancy test and urine pregnancy tests if applicable to exclude pregnancy
Blood samples to measure the levels of the study drug in the circulation
Additional blood samples for future research on PAH andor the mechanism of action of the drug
Electrocardiogram ECG and echocardiogram to assess the size shape pumping action and the extent of any damage to the heart
Brain MRI scan or CT scan if MR is not indicatedtolerated to exclude bleeding in the brain
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 20SC0240 | OTHER | Health Research Authority UK | None |
| 2020-001157-48 | EUDRACT_NUMBER | None | None |
| 20HH5896 | OTHER | None | None |