Trial · NCT04435626
Study to Evaluate the Efficacy (Effect on Disease) and Safety of Finerenone in Participants With Heart Failure and Left Ventricular Ejection Fraction (Proportion of Blood Expelled Per Heart Stroke) Greater or Equal to 40%
NCT04435626, Phase 3, Completed, Bayer; results first posted 2025-08-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Evaluate the Efficacy (Effect on Disease) and Safety of Finerenone in Participants With Heart Failure and Left Ventricular Ejection Fraction (Proportion of Blood Expelled Per Heart Stroke) Greater or Equal to 40%. Trials, record NCT04435626. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04435626
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Study to Evaluate the Efficacy (Effect on Disease) and Safety of Finerenone in Participants With Heart Failure and Left Ventricular Ejection Fraction (Proportion of Blood Expelled Per Heart Stroke) Greater or Equal to 40%
- NCT number
- NCT04435626
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 6,016 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Heart Failure
- Interventions
- Finerenone (BAY94-8862), Placebo
- First posted
- 2020-06-17
- Last updated
- 2025-08-26
- Other registries' IDs
- eudract:2020-000306-29
- Results first posted
- 2025-08-26
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Occurrence of the Composite Endpoint of Cardiovascular Death and Total (First and Recurrent) Heart Failure Events | From randomization up until the end of study, with an average study duration of 32 months | Number of composite endpoint events of cardiovascular death and total (first and recurrent) heart failure (HF) events (hospitalization for heart failure or urgent HF visit) in HF patients. |
| Primary | Occurrence of the Composite Endpoint of Cardiovascular Death and Total (First and Recurrent) Heart Failure Events | From randomization up until the end of study, with an average study duration of 32 months | Number of participants with composite endpoint events of cardiovascular death and total (first and recurrent) heart failure (HF) events (hospitalization for heart failure or urgent HF visit) in HF patients. |
| Secondary | Occurrence of Total (First and Recurrent) Heart Failure Events | From randomization up until the end of study, with an average study duration of 32 months | Number of total (first and recurrent) heart failure events. |
| Secondary | Occurrence of Total (First and Recurrent) Heart Failure Events | From randomization up until the end of study, with an average study duration of 32 months | Number of participants with total (first and recurrent) heart failure events. |
| Secondary | Change From Baseline in Total Symptom Score (TSS) of the Kansas City Cardiomyopathy Questionnaire (KCCQ) | From baseline to Month 6, 9 and 12 | The Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS) is ranged from 0 to 100. A higher score (closer to 100) reflects fewer symptoms, indicating better heart failure symptom status. For the change from baseline the combined and averaged result across the entire time frame is reported. |
| Secondary | Proportion of Participants Who Showed Improvement in NHYA Class | from baseline to Month 12 | The New York Heart Association (NYHA) Functional Classification is a simple scale that classifies patients with heart failure based on the severity of their symptoms and how those symptoms affect their physical activity, which ranges from Class I to Class IV, a lower class number is indicative of a better condition. A patient was considered as having improved in NYHA class, if the NYHA class at Month 12 is at least one category improved compared to the baseline visit. |
| Secondary | First Occurrence of Renal Composite Events | From randomization up to end of study visit, with an average study duration of 32 months | Number of participants with renal composite events encompassing the components sustained decrease in eGFR ≥50% relative to baseline over at least 4 weeks, sustained eGFR decline to \<15 mL/min/1.73 m2 over at least 4 weeks, initiation of chronic dialysis and renal transplantation. |
| Secondary | Occurence of All-cause Mortality (Full Analysis Set) | From randomization until end of study, with an average of 32 months | Number of participants with death due to any cause were reported as descriptive result. Number of participants with outcome death reported here includes deaths occurred after randomization until the end of the study visit. Deaths after end of study visit are not included in this table. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Occurrence of the Composite Endpoint of Cardiovascular Death and Total (First and Recurrent) Heart Failure Events | From randomization up until the end of study, with an average study duration of 32 months | Full analysis set | events | NUMBER |
| PRIMARY | Occurrence of the Composite Endpoint of Cardiovascular Death and Total (First and Recurrent) Heart Failure Events | From randomization up until the end of study, with an average study duration of 32 months | Full analysis set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Occurrence of Total (First and Recurrent) Heart Failure Events | From randomization up until the end of study, with an average study duration of 32 months | Full analysis set | events | NUMBER |
| SECONDARY | Occurrence of Total (First and Recurrent) Heart Failure Events | From randomization up until the end of study, with an average study duration of 32 months | Full analysis set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Total Symptom Score (TSS) of the Kansas City Cardiomyopathy Questionnaire (KCCQ) | From baseline to Month 6, 9 and 12 | Full analysis set with available KCCQ measurements | score on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Proportion of Participants Who Showed Improvement in NHYA Class | from baseline to Month 12 | Full analysis set with available NYHA measurement at baseline | Estimated proportion | NUMBER |
| SECONDARY | First Occurrence of Renal Composite Events | From randomization up to end of study visit, with an average study duration of 32 months | Full analysis set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Occurence of All-cause Mortality (Full Analysis Set) | From randomization until end of study, with an average of 32 months | Full analysis set (FAS) | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Occurrence of the Composite Endpoint of Cardiovascular Death and Total (First and Recurrent) Heart Failure Events | Finerenone (BAY94-8862) | 1083 | events | ||
| Occurrence of the Composite Endpoint of Cardiovascular Death and Total (First and Recurrent) Heart Failure Events | Placebo | 1283 | events | ||
| Occurrence of the Composite Endpoint of Cardiovascular Death and Total (First and Recurrent) Heart Failure Events | Finerenone (BAY94-8862) | 624 | Participants | ||
| Occurrence of the Composite Endpoint of Cardiovascular Death and Total (First and Recurrent) Heart Failure Events | Placebo | 719 | Participants | ||
| Occurrence of Total (First and Recurrent) Heart Failure Events | Finerenone (BAY94-8862) | 842 | events | ||
| Occurrence of Total (First and Recurrent) Heart Failure Events | Placebo | 1024 | events | ||
| Occurrence of Total (First and Recurrent) Heart Failure Events | Finerenone (BAY94-8862) | 479 | Participants | ||
| Occurrence of Total (First and Recurrent) Heart Failure Events | Placebo | 573 | Participants | ||
| Change From Baseline in Total Symptom Score (TSS) of the Kansas City Cardiomyopathy Questionnaire (KCCQ) | Finerenone (BAY94-8862) | 7.99 | 95% Confidence Interval 7.37 to 8.62 | score on scale | |
| Change From Baseline in Total Symptom Score (TSS) of the Kansas City Cardiomyopathy Questionnaire (KCCQ) | Placebo | 6.43 | 95% Confidence Interval 5.79 to 7.07 | score on scale |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Finerenone (BAY94-8862) | 3,011 | |
| Overall Study | STARTED | Placebo | 3,005 | |
| Overall Study | Valid for FAS | Finerenone (BAY94-8862) | 3,003 | |
| Overall Study | Valid for FAS | Placebo | 2,998 | |
| Overall Study | COMPLETED | Finerenone (BAY94-8862) | 2,996 | |
| Overall Study | COMPLETED | Placebo | 2,986 | |
| Overall Study | NOT COMPLETED | Finerenone (BAY94-8862) | 15 | |
| Overall Study | NOT COMPLETED | Placebo | 19 |
Source ClinicalTrials.gov
Adverse events2,811
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 | Finerenone (BAY94-8862) | 169 | 2,993 | 193 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 162 | 2,993 | 178 |
| other | Anaemia | Blood and lymphatic system disorders | Never Received Treatment | 0 | 15 | 0 |
| other | Cardiac failure | Cardiac disorders | Finerenone (BAY94-8862) | 116 | 2,993 | 143 |
| other | Cardiac failure | Cardiac disorders | Placebo | 168 | 2,993 | 218 |
| other | Cardiac failure | Cardiac disorders | Never Received Treatment | 0 | 15 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | Finerenone (BAY94-8862) | 167 | 2,993 | 208 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 129 | 2,993 | 157 |
| other | Diarrhoea | Gastrointestinal disorders | Never Received Treatment | 0 | 15 | 0 |
| other | Urinary tract infection | Infections and infestations | Finerenone (BAY94-8862) | 150 | 2,993 | 184 |
1 to 10 of 2,811Source ClinicalTrials.gov
See all 2,811 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Finerenone (BAY94-8862) | 494 | 2,993 |
| Total, all-cause mortality | Placebo | 528 | 2,993 |
| Total, all-cause mortality | Never Received Treatment | 3 | 15 |
| Total, other adverse events | Finerenone (BAY94-8862) | 1,317 | 2,993 |
| Total, other adverse events | Placebo | 1,228 | 2,993 |
| Total, other adverse events | Never Received Treatment | 0 | 15 |
| Total, serious adverse events | Finerenone (BAY94-8862) | 1,157 | 2,993 |
| Total, serious adverse events | Placebo | 1,213 | 2,993 |
| Total, serious adverse events | Never Received Treatment | 0 | 15 |
Source ClinicalTrials.gov
Papers46
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Finerenone (BAY94-8862) vs Placebo: First Occurrence of Renal Composite Events | Trial comparisons |
| Finerenone (BAY94-8862) vs Placebo: Occurence of All-cause Mortality (Full Analysis Set) | Trial comparisons |
| Finerenone (BAY94-8862) vs Placebo: Occurrence of Total (First and Recurrent) Heart Failure Events | Trial comparisons |
| Finerenone (BAY94-8862) vs Placebo: Occurrence of the Composite Endpoint of Cardiovascular Death and Total (First and Recurrent) Heart Failure 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/NCT04435626
GET https://conductscience.org/api/trials/v1/NCT04435626/events?page=2