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

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Hemodynamic Effects, Safety, Tolerability, and Pharmacokinetics of APD418 in Subjects with Heart Failure with Reduced Ejection Fraction - APD418-201

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-006131-10-PL

Enrollment

Registered

2021-05-13

Start date

2021-09-29

Completion date

Unknown

Last updated

2022-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment of acute heart failure with reduced ejection fraction (HFrEF) MedDRA version: 20.0 Level: LLT Classification code 10000803 Term: Acute heart failure System Organ Class: 100000004849

Interventions

Product Name: APD418 Product Code: APD418 Pharmaceutical Form: Solution for infusion INN or Proposed INN: not applicable CAS Number: 2169905-68-2 Current Sponsor code: APD418, APD418 mesylate hemihydr

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: • To assess the effect of intravenous (IV) infusion of APD418 on hemodynamic status based on cardiac index (CI) in subjects with heart failure with reduced ejection fraction (HFrEF) ;Secondary Objective: • To assess the effect of IV infusion of APD418 on additional hemodynamic, vital sign, and systolic function parameters in subjects with HFrEF • To assess the pharmacokinetics (PK) of IV infusion of APD418 in subjects with HFrEF • To assess the safety and tolerability of IV infusion of APD418 in subjects with HFrEF ;Primary end point(s): Change in CI measured by RHC from Baseline to end of IV infusion at 6 hours ;Timepoint(s) of evaluation of this end point: Baseline to end of intravenous (IV) infusion at 6 hours	—

Measure

Time frame

Main Objective: • To assess the effect of intravenous (IV) infusion of APD418 on hemodynamic status based on cardiac index (CI) in subjects with heart failure with reduced ejection fraction (HFrEF) ;Secondary Objective: • To assess the effect of IV infusion of APD418 on additional hemodynamic, vital sign, and systolic function parameters in subjects with HFrEF • To assess the pharmacokinetics (PK) of IV infusion of APD418 in subjects with HFrEF • To assess the safety and tolerability of IV infusion of APD418 in subjects with HFrEF ;Primary end point(s): Change in CI measured by RHC from Baseline to end of IV infusion at 6 hours ;Timepoint(s) of evaluation of this end point: Baseline to end of intravenous (IV) infusion at 6 hours

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Secondary

Measure	Time frame
Secondary end point(s): Secondary endpoints: • Change in the following hemodynamic parameters measured by RHC from Baseline to end of IV infusion at 6 hours: - Cardiac output (CO) - Pulmonary capillary wedge pressure (PCWP) - Right atrial pressure (RAP) - Systolic/diastolic pulmonary arterial pressure (PAS/PAD) - Pulmonary artery pulsatility index (PAPi) - Systemic vascular resistance/systemic vascular resistance index (SVR/SVRI) - Pulmonary vascular resistance (PVR) • Change in the following vital sign parameters from Baseline to end of IV infusion at 6 hours: - Systolic blood pressure (SBP) - Diastolic blood pressure (DBP) - Mean arterial pressure (MAP) - Heart rate (HR) • Change in the following hemodynamic and systolic function parameters measured by echocardiogram (ECHO) from Baseline to end of IV infusion at 6 hours: - Stroke volume (SV) - SV index (SVI) - Left ventricular ejection fraction (LVEF) - Fractional shortening (FS) - Left ventricular end systolic/left ventricular end-diastolic volume (LVESV/LVEDV) and diameter - Left ventricular global longitudinal strain (LVGLS) - Left ventricular circumferential strain (LVGCS) • Change in hemodynamic (measured by RHC) and vital sign parameters listed above at intermediate timepoints during 6-hour IV infusion (during Dosing Period) • Plasma and urine PK parameters assessed for each dose of APD418 baseline, end of infusion at 6-hours, and intermediate timepoints during 6-hour infusion, as well as post-infusion timepoints • Safety and tolerability of APD418 by incidence of all treatment-emergent adverse events (TEAEs) ;Timepoint(s) of evaluation of this end point: Baseline, end of infusion at 6-hours, intermediate timepoints during 6-hour infusion	—

Measure

Time frame

Secondary end point(s): Secondary endpoints: • Change in the following hemodynamic parameters measured by RHC from Baseline to end of IV infusion at 6 hours: - Cardiac output (CO) - Pulmonary capillary wedge pressure (PCWP) - Right atrial pressure (RAP) - Systolic/diastolic pulmonary arterial pressure (PAS/PAD) - Pulmonary artery pulsatility index (PAPi) - Systemic vascular resistance/systemic vascular resistance index (SVR/SVRI) - Pulmonary vascular resistance (PVR) • Change in the following vital sign parameters from Baseline to end of IV infusion at 6 hours: - Systolic blood pressure (SBP) - Diastolic blood pressure (DBP) - Mean arterial pressure (MAP) - Heart rate (HR) • Change in the following hemodynamic and systolic function parameters measured by echocardiogram (ECHO) from Baseline to end of IV infusion at 6 hours: - Stroke volume (SV) - SV index (SVI) - Left ventricular ejection fraction (LVEF) - Fractional shortening (FS) - Left ventricular end systolic/left ventricular end-diastolic volume (LVESV/LVEDV) and diameter - Left ventricular global longitudinal strain (LVGLS) - Left ventricular circumferential strain (LVGCS) • Change in hemodynamic (measured by RHC) and vital sign parameters listed above at intermediate timepoints during 6-hour IV infusion (during Dosing Period) • Plasma and urine PK parameters assessed for each dose of APD418 baseline, end of infusion at 6-hours, and intermediate timepoints during 6-hour infusion, as well as post-infusion timepoints • Safety and tolerability of APD418 by incidence of all treatment-emergent adverse events (TEAEs) ;Timepoint(s) of evaluation of this end point: Baseline, end of infusion at 6-hours, intermediate timepoints during 6-hour infusion

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Countries

Germany, Greece, Poland, Serbia, United States

Contacts

Public ContactMehreen Hai

Arena Pharmaceuticals, Inc.

ct.gov@arenapharm.com+18582103639

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026