Status:
COMPLETED
REGN5381 in Heart Failure Adult Participants With Elevated Pulmonary Capillary Wedge Pressure
Lead Sponsor:
Regeneron Pharmaceuticals
Conditions:
Heart Failure
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 docto...
Detailed Description
Note: Group A has stopped enrolling and Group B will not enroll participants
Eligibility Criteria
Inclusion
- Key
- 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).
- Systolic blood pressure (SBP) ≥110 mmHg at the screening visit and on day -1
- Hematocrit \>30% at the screening visit and day -1
- Key
Exclusion
- 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
- Pacemaker or defibrillator placement within prior 30 days of randomization
- Severe chronic obstructive pulmonary disease (COPD) (defined as Forced Expiratory Volume in 1st second \[FEV1\] \<50% of predicted or Global Initiative for Chronic Obstructive Lung Disease \[GOLD\] 3 or 4)
- Pulmonary arterial hypertension (World Health Organization \[WHO\] Group 1) and any medical history at any time of more than moderate pulmonary hypertension (ie, moderate-to-severe, or severe pulmonary hypertension, as described in the protocol
- Congenital heart disease (repaired or unrepaired)
- Inability to lie flat for cardiac catheterization
- Note: Other protocol-defined Inclusion/ Exclusion Criteria apply
Key Trial Info
Start Date :
June 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 2 2025
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT05353166
Start Date
June 30 2022
End Date
June 2 2025
Last Update
June 11 2025
Active Locations (1)
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1
ARENSIA Exploratory Medicine at the Republican Clinical Hospital
Chisinau, Moldova, 2025