A Study to Assess the Hemodynamic Effects, Safety, Tolerability, and Pharmacokinetics of Intravenous APD418 in Adult Participants With Heart Failure With Reduced Ejection Fraction
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Acute Heart Failure With Reduced Ejection Fraction
In brief
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).
Key facts
- Study ID
- NCT05139615
- Run by
- Pfizer
- People needed
- 22
- Starts
- 2021-12-28
- Expected to finish
- 2022-09-19
- Last updated by the study team
- 2023-11-09
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- James A. Haley Veterans' Hospital — Tampa, Florida, United States
- UnityPoint Health - Methodist Hospital — Peoria, Illinois, United States
- UTHealth — Houston, Texas, United States
- Health Science Center Utah — Salt Lake City, Utah, United States
- University of Wisconsin — Madison, Wisconsin, United States
- Immanuel Hospital Bernau Brandenburg Heart Center — Bernau bei Berlin, Brandenburg, Germany
- Kerckhoff-Klinik Forschungsgesellschaft GmbH — Bad Nauheim, Germany
- Universitatsmedizin Greifwald — Greifswald, Germany
- Konstantinopouleio General Hospital of Nea Ionia - Patision ''Agia Olga'' — Nea Ionia, Athens, Greece
- Interbalkan European Medical Center — Pylaia, Thessaloniki, Greece
- General University Hospital of Larissa — Larissa, Greece
- American Heart of Poland S.A. — Gniezno, Poland
- Krakowski Szpital Specjalistyczny im. Jana Pawla II — Krakow, Poland
- Uniwersytecki Szpital Kliniczny im Jana Mikulicza-Radeckiego — Wroclaw, Poland
- Clinical Hospital Centre Zemun — Belgrade, Serbia
- University Clinical Centre of Serbia — Belgrade, Serbia
- Institute for Cardiovascular Diseases Dedinje — Belgrade, Serbia
- Clinical Hospital Center Bezanijska Kosa — Belgrade, Serbia
- Institute for Cardiovascular Diseases of Vojvodina — Kamenitz, Serbia
- Clinical Center of Kragujevac — Kragujevac, Serbia
- Healthcare Center Uzice — Užice, Serbia
Full record on ClinicalTrials.gov
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