Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2025-12-24 @ 4:46 PM
Study NCT ID:
NCT04416750
Status:
UNKNOWN
Last Update Posted:
2023-10-10
First Post:
2020-05-28
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Positioning Imatinib for Pulmonary Arterial Hypertension
Sponsor:
Imperial College London
Organization:
Study Overview
Official Title:
Positioning Imatinib for Pulmonary Arterial Hypertension
Status:
UNKNOWN
Status Verified Date:
2023-10
Last Known Status:
ACTIVE_NOT_RECRUITING
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 investigator's 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 drug's 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, he/she 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 and/or 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 indicated/tolerated) 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 drug's 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, he/she 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 and/or 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 indicated/tolerated) to exclude bleeding in the brain
Study Oversight
Has Oversight DMC:
True
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?: