NCT05353166CompletedPhase 2
REGN5381 in Heart Failure Adult Participants With Elevated Pulmonary Capillary Wedge Pressure
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of REGN5381, an NPR1 Agonist, in Heart Failure Patients With Elevated Pulmonary Capillary Wedge Pressure
Source: ClinicalTrials.gov · Last updated 29 Sept 2026
Brief summary (registry, in English)
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)
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 59 (actual)
- First submitted
- 25 Apr 2022
- Start date
- 30 Jun 2022
- Primary completion date
- 2 Jun 2025
- Lead sponsor
- Regeneron Pharmaceuticals
- Diseases
- Heart failure
- NCT number
- NCT05353166
- EU CT number
- 2023-506674-13-00
- EudraCT number
- 2021-006337-19
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 59
- From 30 Jun 2022 to the primary completion date, 2 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently taking IV vasodilators and/or inotropes
- 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
- Acute coronary syndrome within prior 6 months of randomization
- Pacemaker or defibrillator placement within prior 30 days of randomization
Other illness
- History of cardiac arrest
- Cardiac surgery within 3 months 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
Other
- Taking sacubitril/valsartan (only for HFrEF and HFpEF participants not taking sacubitril/valsartan \[Group A and Group C, respectively\])
- Known infiltrative or hypertrophic cardiomyopathy
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| ARENSIA Exploratory Medicine at the Republican Clinical Hospital Coordinator of this site? Confirm its status | Chisinau | Moldova | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.