Study to Evaluate the Effects of AZD3427 in Patients With Heart Failure

Heart Failure Clinical Trial

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Status Withdrawn

Clinical Trial 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.

Clinical Trial 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) ;

Related Conditions & MeSH terms

• Heart Failure

• NCT number: NCT04890548
• Study type: Interventional
• Source: AstraZeneca
• Status: Withdrawn
• Phase: Phase 1
• Start date: November 23, 2021
• Completion date: August 2, 2022