A Study to Assess how Safe and Effective APD418 is in Patients with Heart Failure

Phase 1

• Conditions: Treatment of acute heart failure with reduced ejection fraction (HFrEF); MedDRA version: 20.0Level: LLTClassification code 10000803Term: Acute heart failureSystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2020-006131-10-PL
• Lead Sponsor: Arena Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-13
• Last Update Posted: 21 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Advanced chronic Heart Failure with Reduced Ejection Fraction (HFrEF), defined as left ventricular ejection fraction (LVEF) = 35% at Screening, including documented history of HFrEF (LVEF = 35%) for at least 4 months prior to Screening
• New York Heart Association Class II-IV
• Cardiac index = 2.5 liters per minute per square meter (L/min/m^2) and pulmonary capillary wedge pressure = 15 millimeters of mercury (mm Hg) at Day 1
• Body mass index 18.0 to 37.0 kilograms per square meter (kg/m^2),
inclusive
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 48
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 32

Exclusion Criteria

• Hemodynamically unstable at Day 1 or in the opinion of the Investigator likely to progress to being hemodynamically unstable during the course of the study
• Treated with dobutamine, dopamine, or milrinone within 7 days of Day 1 or with levosimendan within 21 days of Day 1, or expected to require therapy with these drugs any time from Day 1 through the end of study conduct
• Treated with vasoactive or intravenous (IV) diuretic therapy within 24 hours of Day 1, or expected to require IV therapy any time from Day 1 through the end of the in-clinic observation Postdose Period

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified