Ignite Creation Date:
2024-05-06 @ 4:10 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04890548
Status:
WITHDRAWN
Last Update Posted:
2021-12-17
First Post:
2021-05-13
Brief Title:
Study to Evaluate the Effects of AZD3427 in Patients With Heart Failure
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Mechanistic Study to Evaluate the Vasodilatory Effects of AZD3427 in Patients With Heart Failure With Preserved Ejection Fraction HFpEF and Patients With Heart Failure With Reduced Ejection Fraction HFrEF
Status:
WITHDRAWN
Status Verified Date:
2021-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study start up timelines delayed into late autumn and with COVID cases rising in the UK the feasibility of successfully recruiting the study and ethical concerns about starting a study that AZ may not be able to complete
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary purpose of this mechanistic study is to evaluate the vasodilatory effects of AZD3427 in adult patients with heart failure and will be performed at approximately 2 study sites in the United Kingdom
Detailed Description:
The study will enroll patients in 2 cohorts in parallel 1 cohort of patients with heart failure with preserved ejection fraction HFpEF and 1 cohort of patients with heart failure with reduced ejection fraction HFrEF Each cohort plans to enroll at least 7 evaluable patients
All patients will receive the same sequence of 5 intra-arterial IA infusions into the brachial artery consisting of a baseline saline infusion of approximately 20 minutes followed by 3 sequential infusions of AZD3427 at ascending doses of approximately 10 minutes each and a washout saline infusion of approximately 15 minutes
For each patient the study will last at least 51 days and up to 99 days including
A screening period of 1 to 42 days which will include baseline echocardiography
A single-day treatment period during which patients will stay at study site until at least 4 hours after the end of infusions
A follow-up period of 49 to 56 days after the end of the last infusion including
A follow-up phone call on Day 2 within 24 6 hours post-infusion A follow-up visit on Day 8 3 days A follow-up visit on Day 29 2 days A follow-up visit on Day 50 7 days
All patients will receive the same sequence of 5 intra-arterial IA infusions into the brachial artery consisting of a baseline saline infusion of approximately 20 minutes followed by 3 sequential infusions of AZD3427 at ascending doses of approximately 10 minutes each and a washout saline infusion of approximately 15 minutes
For each patient the study will last at least 51 days and up to 99 days including
A screening period of 1 to 42 days which will include baseline echocardiography
A single-day treatment period during which patients will stay at study site until at least 4 hours after the end of infusions
A follow-up period of 49 to 56 days after the end of the last infusion including
A follow-up phone call on Day 2 within 24 6 hours post-infusion A follow-up visit on Day 8 3 days A follow-up visit on Day 29 2 days A follow-up visit on Day 50 7 days
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