Heart Failure Clinical Trial

A Study to Assess the Hemodynamic Effects, Safety, Tolerability, and Pharmacokinetics of Intravenous APD418 in Adult Participants With Heart Failure With Reduced Ejection Fraction

Summary

The purpose of this study is to evaluate the safety, pharmacokinetics, and effect on cardiac function of intravenous APD418 in adult participants with heart failure with reduced ejection fraction (HFrEF).

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Full Description

This study has an adaptive design, in which dose escalation in Part A will inform dose expansion in Part B. Part A is a single-ascending dose, placebo-controlled study planned to consist of 5 cohorts evaluating 5 doses of APD418. Part B is a parallel-treatment group study planned to evaluate 2 doses of APD418 and placebo. Participants in Part A cannot participate in Part B.

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Eligibility Criteria

Inclusion Criteria:

Advanced chronic Heart Failure with Reduced Ejection Fraction (HFrEF), defined as left ventricular ejection fraction (LVEF) less than or equal to (≤) 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, and body weight < 150 kg at Screening and Day 1

Exclusion Criteria:

Hemodynamically unstable at Day 1 or in the opinion of the Investigator likely to progress to becoming hemodynamically unstable during the course of the study
Treated with carvedilol or at a dose higher than a total of 25 milligrams per day any time within 72 hours of Day 1 through the end of the in-clinic observation Post-dose Period.
Receiving any mechanical (respiratory or circulatory) or renal support therapy at Screening or Day 1
Systolic Blood Pressure ≤ 90 millimeter of mercury (mm Hg) or ≥ 160 mm Hg, or Heart Rate < 50 beats per minute (bpm) or > 110 bpm, at Screening or Day 1
Recently treated with inotropic, intravenous (IV) vasoactive or IV diuretic therapy, or expected to require such therapy with these drugs any time from Day 1 through the end of study conduct.

Study is for people with:

Heart Failure

Phase:

Phase 2

Estimated Enrollment:

22

Study ID:

NCT05139615

Recruitment Status:

Terminated

Sponsor:

Pfizer

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There are 21 Locations for this study

See Locations Near You

James A. Haley Veterans' Hospital
Tampa Florida, 33612, United States
UnityPoint Health - Methodist Hospital
Peoria Illinois, 61606, United States
UTHealth
Houston Texas, 77030, United States
Health Science Center Utah
Salt Lake City Utah, 84132, United States
University of Wisconsin
Madison Wisconsin, 53792, United States
Immanuel Hospital Bernau Brandenburg Heart Center
Bernau bei Berlin Brandenburg, 16321, Germany
Kerckhoff-Klinik Forschungsgesellschaft GmbH
Bad Nauheim , 61231, Germany
Universitatsmedizin Greifwald
Greifswald , 17475, Germany
Konstantinopouleio General Hospital of Nea Ionia - Patision ''Agia Olga''
Nea Ionia Athens, 14233, Greece
Interbalkan European Medical Center
Pylaia Thessaloniki, 55535, Greece
General University Hospital of Larissa
Larissa , 41110, Greece
American Heart of Poland S.A.
Gniezno , 62-20, Poland
Krakowski Szpital Specjalistyczny im. Jana Pawla II
Krakow , 31-20, Poland
Uniwersytecki Szpital Kliniczny im Jana Mikulicza-Radeckiego
Wroclaw , 50-55, Poland
Clinical Hospital Centre Zemun
Belgrade , 11 07, Serbia
University Clinical Centre of Serbia
Belgrade , 11000, Serbia
Institute for Cardiovascular Diseases Dedinje
Belgrade , 11040, Serbia
Clinical Hospital Center Bezanijska Kosa
Belgrade , 11080, Serbia
Clinical Center of Kragujevac
Kragujevac , 34000, Serbia
Institute for Cardiovascular Diseases of Vojvodina
Sremska Kamenica , 21204, Serbia
Healthcare Center Uzice
Užice , 31000, Serbia

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Phase:

Phase 2

Estimated Enrollment:

22

Study ID:

NCT05139615

Recruitment Status:

Terminated

Sponsor:


Pfizer

How clear is this clinincal trial information?

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