Study identifier:D8330C00002
ClinicalTrials.gov identifier:NCT04890548
EudraCT identifier:N/A
CTIS identifier:N/A
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)
heart failure
Phase 1
No
AZD3427
All
16
Interventional
18 Years - 75 Years
Allocation: N/A
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Oct 2021 by AstraZeneca
AstraZeneca
PAREXEL
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.
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)
Location
Location
Cambridge, United Kingdom, CB2 0QQ
Location
London, United Kingdom, W1N 8AA
Arms | Assigned Interventions |
---|---|
Experimental: Patients with HFpEF or HFrEF Patients will be enrolled in 2 cohorts in parallel: 1 cohort of patients with HFpEF and 1 cohort of patients with HFrEF. Patients will receive a sequence of 5 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. | Drug: AZD3427 Patients will receive 5 IA infusions of AZD3427 into the brachial artery. The IA infusions of AZD3427 will be administered via a syringe pump, using a polypropylene syringe containing 0.9% (w/v) saline and delivered through an administration set comprising a syringe, extension tubing (PVC), and a 0.2- or 0.22-μm PVDF syringe filter. |
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