REGN5381 in Heart Failure Adult Participants With Elevated Pulmonary Capillary Wedge Pressure (NCT05353166) | Clinical Trial Compass
CompletedPhase 2
REGN5381 in Heart Failure Adult Participants With Elevated Pulmonary Capillary Wedge Pressure
Moldova59 participantsStarted 2022-06-30
Plain-language summary
This study is researching an experimental drug called REGN5381, further referred to as study drug. The study is focused on adult participants with heart failure that, in the opinion of the study doctor, have a clinical indication for right heart catheterization (RHC). The aim of the study is to evaluate the safety and tolerability of the study drug.
The study is looking at several other research questions, including:
* What side effects may happen from taking the study drug
* How much study drug is in the blood at different times
* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Body mass index (BMI) between 18 and 35 kg/m\^2, inclusive, rounded to the nearest whole number
✓. Ambulatory participants with New York Heart Association (NYHA) class II/III heart failure and at least 1 sign and/or symptom of congestion (eg, dyspnea on exertion, worsening edema, orthopnea, etc.)
✓. Left ventricular ejection fraction (LVEF) ≥20 % and \<50% on echocardiogram (ie, HFrEF participants) within 90 days prior to randomization (only for HFrEF participants in Group A and Group B).
✓. Participants who, in the opinion of the investigator, require a right heart catheterization (not applicable for HFrEF patients not taking sacubitril/valsartan \[Group A\]).
✓. Left ventricular ejection fraction (LVEF) ≥50% on echocardiogram (ie, HFpEF participants) within 90 days prior to randomization (only for HFpEF participants in Group C)
✓. NT-proBNP \>1000 pg/mL or Brain Natriuretic Peptide (active form) (BNP) \>300 pg/mL as described in the protocol within 30 days prior to randomization measured by the local laboratory (only for HFrEF participants \[Group A and Group B\]).
✓. Pulmonary capillary wedge pressure (PCWP) ≥15 mmHg and right artrial pressure (RAP) \>5 mmHg on right heart catheterization (RHC) the morning of anticipated study drug dose administration (not applicable for HFrEF participants not taking sacubitril/valsartan \[Group A\] as described in the protocol).
What they're measuring
1
Incidence and severity of treatment-emergent adverse events (TEAEs)
Timeframe: Through the end-of-study (EOS) visit up to 126 days post-dose
✓. Systolic blood pressure (SBP) ≥110 mmHg at the screening visit and on day -1
Exclusion criteria
✕. Currently taking IV vasodilators and/or inotropes
✕. Taking sacubitril/valsartan (only for HFrEF and HFpEF participants not taking sacubitril/valsartan \[Group A and Group C, respectively\])
✕. Taking a phosphodiesterase (PDE) inhibitor (eg, sildenafil), or a soluble guanylate cyclase stimulator (SGCS; ie, vericiguat) within 2 weeks of the screening visit or planning on taking valsartan/sacubitril, a PDE inhibitor, or a SGCS at any point during the study
✕. More than moderate valvular regurgitation/stenosis (ie, moderate-to-severe or severe) on echocardiogram within 90 days prior to randomization
✕. Known infiltrative or hypertrophic cardiomyopathy
✕. Acute coronary syndrome within prior 6 months of randomization
✕. History of cardiac arrest
✕. Cardiac surgery within 3 months of randomization