Trial · NCT05093933
A Study of Vericiguat (MK-1242) in Participants With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF) (MK-1242-035)
NCT05093933, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2025-12-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Vericiguat (MK-1242) in Participants With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF) (MK-1242-035). Trials, record NCT05093933. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05093933
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Vericiguat (MK-1242) in Participants With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF) (MK-1242-035)
- NCT number
- NCT05093933
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 6,106 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Chronic Heart Failure With Reduced Ejection Fraction
- Interventions
- Vericiguat, Placebo
- First posted
- 2021-10-26
- Last updated
- 2025-12-19
- Other registries' IDs
- eudract:2020-005941-18
- Results first posted
- 2025-12-19
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to First Occurrence of Composite Endpoint of Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization: Participants With an Event Per 100 Patient-Years | 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 | Time to CV Death: Participants With an Event Per 100 Patient-Years | 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. |
| Secondary | Time to First Occurrence of HF Hospitalization: Participants With an Event Per 100 Patient-Years | 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. |
| Secondary | Time to Total HF Hospitalizations (Including First and Recurrent Events): Total Events Per 100 Patient-Years | 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. |
| Secondary | Time to First Occurrence of Composite Endpoint of All-Cause Mortality or HF Hospitalization: Participants With an Event Per 100 Patient-Years | 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. |
| Secondary | Time to All-Cause Mortality: Participants With an Event Per 100 Patient-Years | 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. |
| Secondary | Percentage of Participants Who Experienced One or More Selected Nonserious Adverse Events (NSAEs) | 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. |
| Secondary | Percentage of Participants Who Experienced One or More Serious Adverse Events (SAEs) | 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. |
| Secondary | Percentage of Participants Who Experienced One or More Events of Clinical Interest (ECIs) | 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. |
| Secondary | Percentage of Participants Who Experienced One or More Potential DILI ECIs | 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. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to First Occurrence of Composite Endpoint of Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization: Participants With an Event Per 100 Patient-Years | Up to approximately 36 months (from randomization to the primary completion data cutoff) | All randomized participants who had GCP-compliant data collected. | Pts. with event/100 patient-yrs at risk | NUMBER |
| SECONDARY | Time to CV Death: Participants With an Event Per 100 Patient-Years | Up to approximately 36 months (from randomization to the primary completion data cutoff) | All randomized participants who had GCP-compliant data collected. | Pts. with event/100 patient-yrs at risk | NUMBER |
| SECONDARY | Time to First Occurrence of HF Hospitalization: Participants With an Event Per 100 Patient-Years | Up to approximately 36 months (from randomization to the primary completion data cutoff) | All randomized participants who had GCP-compliant data collected. | Pts. with event/100 patient-yrs at risk | NUMBER |
| SECONDARY | Time to Total HF Hospitalizations (Including First and Recurrent Events): Total Events Per 100 Patient-Years | Up to approximately 36 months (from randomization to the primary completion data cutoff) | All randomized participants who had GCP-compliant data collected. | Total events/100 patient-yrs at risk | NUMBER |
| SECONDARY | Time to First Occurrence of Composite Endpoint of All-Cause Mortality or HF Hospitalization: Participants With an Event Per 100 Patient-Years | Up to approximately 36 months (from randomization to the primary completion data cutoff) | All randomized participants who had GCP-compliant data collected. | Pts. with event/100 patient-yrs at risk | NUMBER |
| SECONDARY | Time to All-Cause Mortality: Participants With an Event Per 100 Patient-Years | Up to approximately 36 months (from randomization to the primary completion data cutoff) | All randomized participants who had GCP-compliant data collected. | Pts. with event/100 patient-yrs at risk | NUMBER |
| SECONDARY | Percentage of Participants Who Experienced One or More Selected Nonserious Adverse Events (NSAEs) | Up to approximately 36 months (from randomization to the primary completion data cutoff) | All randomized participants who received at least 1 dose of study intervention and who had GCP-compliant data collected. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Experienced One or More Serious Adverse Events (SAEs) | Up to approximately 36 months (from randomization to the primary completion data cutoff) | All randomized participants who received at least 1 dose of study intervention and who had GCP-compliant data collected. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Experienced One or More Events of Clinical Interest (ECIs) | Up to approximately 36 months (from randomization to the primary completion data cutoff) | All randomized participants who received at least 1 dose of study intervention and who had GCP-compliant data collected. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Experienced One or More Potential DILI ECIs | Up to approximately 36 months (from randomization to the primary completion data cutoff) | All randomized participants who received at least 1 dose of study intervention and who had GCP-compliant data collected. | Percentage of Participants | NUMBER |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to First Occurrence of Composite Endpoint of Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization: Participants With an Event Per 100 Patient-Years | Vericiguat | 11.3 | Pts. with event/100 patient-yrs at risk | ||
| Time to First Occurrence of Composite Endpoint of Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization: Participants With an Event Per 100 Patient-Years | Placebo | 12.2 | Pts. with event/100 patient-yrs at risk | ||
| Time to CV Death: Participants With an Event Per 100 Patient-Years | Vericiguat | 5.7 | Pts. with event/100 patient-yrs at risk | ||
| Time to CV Death: Participants With an Event Per 100 Patient-Years | Placebo | 6.8 | Pts. with event/100 patient-yrs at risk | ||
| Time to First Occurrence of HF Hospitalization: Participants With an Event Per 100 Patient-Years | Vericiguat | 7.2 | Pts. with event/100 patient-yrs at risk | ||
| Time to First Occurrence of HF Hospitalization: Participants With an Event Per 100 Patient-Years | Placebo | 7.6 | Pts. with event/100 patient-yrs at risk | ||
| Time to Total HF Hospitalizations (Including First and Recurrent Events): Total Events Per 100 Patient-Years | Vericiguat | 10.7 | Total events/100 patient-yrs at risk | ||
| Time to Total HF Hospitalizations (Including First and Recurrent Events): Total Events Per 100 Patient-Years | Placebo | 11.8 | Total events/100 patient-yrs at risk | ||
| Time to First Occurrence of Composite Endpoint of All-Cause Mortality or HF Hospitalization: Participants With an Event Per 100 Patient-Years | Vericiguat | 12.7 | Pts. with event/100 patient-yrs at risk | ||
| Time to First Occurrence of Composite Endpoint of All-Cause Mortality or HF Hospitalization: Participants With an Event Per 100 Patient-Years | Placebo | 13.9 | Pts. with event/100 patient-yrs at risk |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vericiguat | 3,053 | |
| Overall Study | STARTED | Placebo | 3,052 | |
| Overall Study | Treated | Vericiguat | 3,049 | |
| Overall Study | Treated | Placebo | 3,049 | |
| Overall Study | COMPLETED | Vericiguat | 2,648 | |
| Overall Study | COMPLETED | Placebo | 2,571 | |
| Overall Study | NOT COMPLETED | Vericiguat | 405 | |
| Overall Study | NOT COMPLETED | Placebo | 481 |
Source ClinicalTrials.gov
Adverse events1,218
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Vericiguat | 171 | 3,049 | 190 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 143 | 3,049 | 154 |
| other | Hypotension | Vascular disorders | Vericiguat | 401 | 3,049 | 502 |
| other | Hypotension | Vascular disorders | Placebo | 312 | 3,049 | 380 |
| serious | Anaemia | Blood and lymphatic system disorders | Vericiguat | 26 | 3,049 | 28 |
| serious | Anaemia | Blood and lymphatic system disorders | Placebo | 34 | 3,049 | 35 |
| serious | Anaemia macrocytic | Blood and lymphatic system disorders | Vericiguat | 2 | 3,049 | 2 |
| serious | Anaemia macrocytic | Blood and lymphatic system disorders | Placebo | 0 | 3,049 | 0 |
| serious | Aplastic anaemia | Blood and lymphatic system disorders | Vericiguat | 0 | 3,049 | 0 |
| serious | Aplastic anaemia | Blood and lymphatic system disorders | Placebo | 1 | 3,049 | 1 |
1 to 10 of 1,218Source ClinicalTrials.gov
See all 1,218 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vericiguat | 392 | 3,053 |
| Total, all-cause mortality | Placebo | 455 | 3,052 |
| Total, other adverse events | Vericiguat | 530 | 3,049 |
| Total, other adverse events | Placebo | 423 | 3,049 |
| Total, serious adverse events | Vericiguat | 732 | 3,049 |
| Total, serious adverse events | Placebo | 766 | 3,049 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Vericiguat vs Placebo: deaths from any cause | Trial comparisons |
| Vericiguat vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05093933
GET https://conductscience.org/api/trials/v1/NCT05093933/results?page=2