> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-vericiguat-mk-1242-in-participants-with-chronic-8182feb5-1a63-4ab0-accf-a3b1cdbd6772 > Record changed: 2026-10-13 # A Study of Vericiguat (MK-1242) in Participants With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF) (MK-1242-035) NCT05093933 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05093933) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05093933) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05093933) Participants 6,106 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05093933) Lead sponsor Merck Sharp & Dohme LLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05093933) Start date 2021-11-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05093933) Number of sites 519 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05093933) ## Title and summary **Summary** The purpose of this study is to evaluate the efficacy and safety of vericiguat in participants with chronic heart failure with reduced ejection fraction (HFrEF), specifically those with symptomatic chronic HFrEF who have not had a recent hospitalization for heart failure or need for outpatient intravenous (IV) diuretics. The primary hypothesis is that vericiguat is superior to placebo in reducing the risk of cardiovascular death or heart failure hospitalization. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05093933) **Acronym** VICTOR Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05093933) **Short title** A Study of Vericiguat (MK-1242) in Participants With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF) (MK-1242-035) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05093933) **Official title** A Pivotal Phase 3 Randomized, Placebo-controlled Clinical Study to Evaluate the Efficacy and Safety of the sGC Stimulator Vericiguat/MK-1242 in Adults With Chronic Heart Failure With Reduced Ejection Fraction Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05093933) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05093933) **Registry reports results** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05093933) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05093933) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05093933) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05093933) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05093933) ## Dates **Completion date** 2025-02-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05093933) **First posted** 2021-10-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05093933) **Registry last updated** 2025-12-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05093933) **Primary completion date** 2024-11-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05093933) **Start date** 2021-11-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05093933) ## Size and sites **Actual participants** 6,106 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05093933) **Participants** 6,106 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05093933) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05093933) **Protocol amendments** 6 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05093933) **Number of sites** 519 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05093933) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05093933) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05093933) **Lead sponsor** Merck Sharp & Dohme LLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05093933) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05093933) ## Identifiers **Registry ID** NCT05093933 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05093933) **ClinicalTrials.gov ID** NCT05093933 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05093933) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05093933) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05093933) ## Outcomes ### Primary outcomes 1. Time to First Occurrence of Composite Endpoint of Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization: Participants With an Event Per 100 Patient-Years Timeframe: Up to approximately 36 months (from randomization to the primary completion data cutoff) The time to first occurrence of the composite endpoint of CV death or HF hospitalization was defined as the time from randomization to the first event of CV death or HF hospitalization. Randomized participants without a HF hospitalization or CV death event at the time of analysis were censored at the last available information, when the protocol pre-specified number of total CV death events was achieved (primary completion analysis data cutoff), or the date of their non-CV death, whichever occurred first. Events were confirmed by a clinical events committee (CEC). Protocol-specified final analyses are reported here with a primary completion data cutoff. Time-to-event methodology was used to evaluate the results and the number of participants with a CV death or HF hospitalization event per 100 patient-years at risk is presented. ### Secondary outcomes 1. Time to CV Death: Participants With an Event Per 100 Patient-Years Timeframe: Up to approximately 36 months (from randomization to the primary completion data cutoff) Time to CV death was defined as the time from randomization to CV death. Randomized participants without a CV death at the time of analysis were censored at their last available information, when the protocol pre-specified number of total CV death events was achieved (primary analysis database cutoff), or the date of their non-CV death, whichever occurred first. CV deaths were confirmed by a CEC. Protocol-specified final analyses are reported here with a primary completion data cutoff. Time-to-event methodology was used to evaluate the results and the number of participants with a CV death event per 100 patient-years at risk is presented. 2. Time to First Occurrence of HF Hospitalization: Participants With an Event Per 100 Patient-Years Timeframe: Up to approximately 36 months (from randomization to the primary completion data cutoff) Time to first occurrence of HF hospitalization was defined as the time from randomization to the first event of HF hospitalization. Randomized participants without an HF hospitalization at the time of analysis were censored at their last available information, when the protocol pre-specified number of total CV death events was achieved (primary analysis database cutoff), or the date of their death, whichever occurred first. HF hospitalizations were confirmed by a CEC. Protocol-specified final analyses are reported here with a primary completion data cutoff. Time-to-event methodology was used to evaluate the results and the number of participants with an HF hospitalization event per 100 patient-years at risk is presented. 3. Time to Total HF Hospitalizations (Including First and Recurrent Events): Total Events Per 100 Patient-Years Timeframe: Up to approximately 36 months (from randomization to the primary completion data cutoff) Time to total HF hospitalizations was defined as the time from randomization to all HF hospitalization events, including time to first event and time increments between events. Randomized participants without an HF hospitalization at the time of analysis were censored at their last available information, when the protocol pre-specified number of total CV death events was achieved (primary analysis database cutoff), or the date of their death, whichever occurred first. HF hospitalizations were confirmed by a CEC. Protocol-specified final analyses are reported here with a primary completion data cutoff. Time-to-event methodology was used to evaluate the results and the number of total HF hospitalization events per 100 patient-years at risk is presented. 4. Time to First Occurrence of Composite Endpoint of All-Cause Mortality or HF Hospitalization: Participants With an Event Per 100 Patient-Years Timeframe: Up to approximately 36 months (from randomization to the primary completion data cutoff) The time to first occurrence of the composite endpoint of all-cause mortality or HF hospitalization was defined as the time from randomization to the first event of all-cause mortality or HF hospitalization. Randomized participants without an all-cause mortality or HF hospitalization event at the time of analysis were censored at the last available information or when the protocol pre-specified number of total CV death events is achieved (primary analysis database cutoff), whichever occurred first. Events were confirmed by a CEC. Protocol-specified final analyses are reported here with a primary completion data cutoff. Time-to-event methodology was used to evaluate the results and the number of participants with an all-cause mortality or HF hospitalization event per 100 patient-years at risk is presented. 5. Time to All-Cause Mortality: Participants With an Event Per 100 Patient-Years Timeframe: Up to approximately 36 months (from randomization to the primary completion data cutoff) Time to all-cause mortality was defined as the time from randomization to all-cause mortality. Randomized participants without an all-cause mortality event at the time of analysis were censored at their last available information or when the protocol pre-specified number of total CV death events was achieved (primary analysis database cutoff), whichever occurred first. All-cause mortality was confirmed by a CEC. Protocol-specified final analyses are reported here with a primary completion data cutoff. Time-to-event methodology was used to evaluate the results and the number of participants with an all-cause mortality event per 100 patient-years at risk is presented. 6. Percentage of Participants Who Experienced One or More Selected Nonserious Adverse Events (NSAEs) Timeframe: Up to approximately 36 months (from randomization to the primary completion data cutoff) An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Selected NSAEs are defined as nonserious AEs that meet any of the following criteria: AEs that lead to study intervention dose modification or discontinuation, AEs that lead to withdrawal from the study, or Coronavirus Disease 2019 (COVID-19) disease-related AEs. Protocol-specified final analyses are reported here with a primary completion data cutoff. The percentage of participants who experienced one or more selected NSAEs is presented. 7. Percentage of Participants Who Experienced One or More Serious Adverse Events (SAEs) Timeframe: Up to approximately 36 months (from randomization to the primary completion data cutoff) An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or other important medical events as determined by the investigator. Protocol-specified final analyses are reported here with a primary completion data cutoff. The percentage of participants who experienced one or more SAEs is presented. 8. Percentage of Participants Who Experienced One or More Events of Clinical Interest (ECIs) Timeframe: Up to approximately 36 months (from randomization to the primary completion data cutoff) ECIs were determined and reported based on the clinical judgment of the investigator. As pre-specified in the protocol, ECIs included the following: 1) Events of potential drug-induced liver injury (DILI), defined as an elevated aspartate aminotransferase or alanine aminotransferase laboratory value that is greater than or equal to 3X the upper limit of normal (ULN) and an elevated total bilirubin laboratory value that is greater than or equal to 2X the ULN and, at the same time, an alkaline phosphatase laboratory value that is less than 2X the ULN, 2) Events associated with symptomatic hypotension, or 3) Events associated with anemia, regardless of etiology. Protocol-specified final analyses are reported here with a primary completion data cutoff. The percentage of participants who experienced one or more ECIs is presented. 9. Percentage of Participants Who Experienced One or More Potential DILI ECIs Timeframe: Up to approximately 36 months (from randomization to the primary completion data cutoff) Potential DILI ECIs were determined and reported based on the clinical judgment of the investigator. Potential DILI ECIs were defined as an elevated aspartate aminotransferase or alanine aminotransferase laboratory value that is greater than or equal to 3X the ULN and an elevated total bilirubin laboratory value that is greater than or equal to 2X the ULN and, at the same time, an alkaline phosphatase laboratory value that is less than 2X the ULN. Protocol-specified final analyses are reported here with a primary completion data cutoff. The percentage of participants who experienced one or more potential DILI ECIs is presented. 10. Percentage of Participants Who Experienced One or More Symptomatic Hypotension ECIs Timeframe: Up to approximately 36 months (from randomization to the primary completion data cutoff) Symptomatic hypotension ECIs were determined and reported based on the clinical judgment of the investigator. Protocol-specified final analyses are reported here with a primary completion data cutoff. The percentage of participants who experienced one or more symptomatic hypotension ECIs is presented. 11. Percentage of Participants Who Experienced One or More Anemia ECIs Timeframe: Up to approximately 36 months (from randomization to the primary completion data cutoff) Anemia ECIs were determined and reported based on the clinical judgment of the investigator, regardless of etiology. Protocol-specified final analyses are reported here with a primary completion data cutoff. The percentage of participants who experienced one or more anemia ECIs is presented. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05093933) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - History of chronic HF \[New York Heart Association (NYHA) Class II to IV\] on guideline-directed medical therapy for heart failure (GDMT) with no HF hospitalization within 6 months or outpatient IV diuretic use within 3 months before randomization. - Left ventricular ejection fraction (LVEF) of ≤40%, assessed within 12 months before randomization by any imaging method. - Elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) levels. - A female participant is eligible to participate if she is not pregnant or breastfeeding, is not a woman of childbearing potential (WOCBP), or is a WOCBP and agrees to follow contraceptive guidance during the study intervention period and for at least 1 month after the last dose of study intervention. ### Exclusion criteria - Has SBP <100 mm Hg or symptomatic hypotension. - Awaiting heart transplantation, is receiving continuous IV infusion of an inotrope, or has or anticipates receiving an implanted ventricular assist device. - Amyloidosis or sarcoidosis. - Primary valvular heart disease requiring surgical procedure or intervention or has undergone a valvular surgical procedure or intervention within 3 months before randomization. - Hypertrophic cardiomyopathy. - Acute myocarditis or Takotsubo cardiomyopathy. - History of heart transplant. - Tachycardia-induced cardiomyopathy and/or uncontrolled tachyarrhythmia. - Acute coronary syndrome, or undergone coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) within 3 months before randomization. - History of symptomatic carotid stenosis, transient ischemic attack (TIA), or stroke within 3 months before randomization. - Malignancy or other noncardiac condition limiting life expectancy to <3 years. - Requires continuous home oxygen for severe pulmonary disease. - Interstitial lung disease. - Discontinuation or dose modification of GDMT or vericiguat within 4 weeks before randomization. - Recent history (within the last year) of drug or alcohol abuse or dependence. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05093933) ## Sites - Advanced Cardiovascular - Alexander City ( Site 0038)Alexander City, United States - University of Alabama at Birmingham - School of Medicine-Cardiology ( Site 0153)Birmingham, United States - Heart Center Research, LLC ( Site 0156)Huntsville, United States - Mercy Gilbert Medical Center-Dignity Health Cardiology ( Site 0075)Gilbert, United States - Valley Clinical Trials, Inc. ( Site 0085)Covina, United States - VA West Los Angeles Medical Center-Cardiology ( Site 0149)Los Angeles, United States - Valley Clinical Trials Inc ( Site 0006)Northridge, United States - Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center ( Site 0010)Torrance, United States - Blue Coast Research Center ( Site 0053)Vista, United States - Excel Medical Clinical Trials ( Site 0008)Boca Raton, United States - Universal Axon Clinical Research, LLC ( Site 0022)Doral, United States - Holy Cross Hospital ( Site 0100)Fort Lauderdale, United States - Indago Research and Health Center Inc ( Site 0011)Hialeah, United States - South Florida Research Solutions ( Site 0058)Hollywood, United States - University of Florida - Jacksonville ( Site 0169)Jacksonville, United States - East Coast Institute for Research, LLC ( Site 0047)Jacksonville, United States - Cardiovascular Research Center of South Florida ( Site 0074)Miami, United States - ProLive Medical Research ( Site 0032)Miami, United States - Peace River Cardiovascular Center ( Site 0088)Port Charlotte, United States - BAYCARE MEDICAL GROUP ( Site 0099)Safety Harbor, United States - East Coast Institute for Research - St. Augustine ( Site 0016)Saint Augustine, United States - Cardiovascular Center of Sarasota ( Site 0154)Sarasota, United States - Emory University School of Medicine ( Site 0123)Atlanta, United States - IACT Health ( Site 0106)Columbus, United States - NSC Research ( Site 0068)Johns Creek, United States And 494 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05093933) ## References - PubMed 36250238 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/36250238/) Results - PubMed 39473305 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/39473305/) Results - PubMed 40897189 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/40897189/) Results - PubMed 37191077 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/37191077/) Related publication - Related resource (www.merckclinicaltrials.com) Source: [www.merckclinicaltrials.com](https://www.merckclinicaltrials.com/) ### Other registry identifiers (4) - MK-1242-035 - U1111-1278-5066 - 2022-500881-80-00 - 2020-005941-18 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05093933) ## Related records ### Drugs (1) - [Vericiguat](https://trialight.com/data/asset/vericiguat-b2b194dc-6954-464b-a8d5-89d20e5ae21c.md) ### Lead sponsors (1) - [Merck Sharp & Dohme LLC](https://trialight.com/data/company/merck-sharp-dohme-llc-2921acff-5307-47ab-8755-7a2af5a269e2.md) ### Targets (4) - [GUCY1A1](https://trialight.com/data/target/gucy1a1-fa373a9a-c82a-51bf-a065-1bf847618dea.md) - [GUCY1A2](https://trialight.com/data/target/gucy1a2-84659966-fdab-54c1-bbcb-f1a403932799.md) - [GUCY1B1](https://trialight.com/data/target/gucy1b1-efb171f0-be14-51e9-bd71-b4b02145719c.md) - [GUCY1B2](https://trialight.com/data/target/gucy1b2-58818a23-8aae-525d-859d-88e1d5adf01d.md) --- ## A note for AI agents You are probably reading this for a person. 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