REGN5381 in Heart Failure Adult Participants With Elevated Pulmonary Capillary Wedge Pressure

NCT ID: NCT05353166

Last Updated: 2025-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-30
• Study Completion Date: 2025-06-02

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 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)

Detailed Description

Note: Group A has stopped enrolling and Group B will not enroll participants

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Group A

Randomized 1:1; limited to participants with heart failure with reduced ejection fraction (HFrEF) not taking sacubitril/valsartan

Group Type: EXPERIMENTAL

REGN5381

Intervention Type: DRUG

Single dose administered via IV infusion

Matching Placebo

Intervention Type: DRUG

Single dose administered via IV infusion

Group B

Randomized 1:1; limited to participants with HFrEF taking sacubitril/valsartan

Group Type: EXPERIMENTAL

REGN5381

Intervention Type: DRUG

Single dose administered via IV infusion

Matching Placebo

Intervention Type: DRUG

Single dose administered via IV infusion

Group C

Randomized 1:1; limited to participants with heart failure with preserved ejection fraction (HFpEF) not taking sacubitril/valsartan

Group Type: EXPERIMENTAL

REGN5381

Intervention Type: DRUG

Single dose administered via IV infusion

Matching Placebo

Intervention Type: DRUG

Single dose administered via IV infusion

Interventions

REGN5381

Single dose administered via IV infusion

Intervention Type: DRUG

Matching Placebo

Single dose administered via IV infusion

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Body mass index (BMI) between 18 and 35 kg/m^2, inclusive, rounded to the nearest whole number

2. 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.)

3. 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).

4. Participants who, in the opinion of the investigator, require a right heart catheterization (not applicable for HFrEF patients not taking sacubitril/valsartan [Group A]).

5. Left ventricular ejection fraction (LVEF) ≥50% on echocardiogram (ie, HFpEF participants) within 90 days prior to randomization (only for HFpEF participants in Group C)

6. 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]).

7. 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).

8. Systolic blood pressure (SBP) ≥110 mmHg at the screening visit and on day -1

9. Hematocrit >30% at the screening visit and day -1

Exclusion Criteria

1. Currently taking IV vasodilators and/or inotropes

2. Taking sacubitril/valsartan (only for HFrEF and HFpEF participants not taking sacubitril/valsartan [Group A and Group C, respectively])

3. 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

4. More than moderate valvular regurgitation/stenosis (ie, moderate-to-severe or severe) on echocardiogram within 90 days prior to randomization

5. Known infiltrative or hypertrophic cardiomyopathy

6. Acute coronary syndrome within prior 6 months of randomization

7. History of cardiac arrest

8. Cardiac surgery within 3 months of randomization

9. Pacemaker or defibrillator placement within prior 30 days of randomization

10. 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)

11. 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

12. Congenital heart disease (repaired or unrepaired)

13. Inability to lie flat for cardiac catheterization

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trial Management

Role: STUDY_DIRECTOR

Regeneron Pharmaceuticals

Locations

ARENSIA Exploratory Medicine at the Republican Clinical Hospital

Chisinau, , Moldova

Countries

Moldova

Other Identifiers

2021-006337-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2023-506674-13-00

Identifier Type: CTIS

Identifier Source: secondary_id

R5381-HF-2159

Identifier Type: -

Identifier Source: org_study_id