CompletedNCT01807221ARTS-HFUpdated Jul 6, 2021Results posted

Phase IIb Safety and Efficacy Study of Different Oral Doses of BAY94-8862 in Subjects With Worsening Chronic Heart Failure and Left Ventricular Systolic Dysfunction and Either Type 2 Diabetes Mellitus With or Without Chronic Kidney Disease or Chronic Kidney Disease Alone

A Phase 2 interventional study of Finerenone (BAY94-8862) and Placebo in Heart Failure, sponsored by Bayer. Completed at 172 sites in 25 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-06.

Sponsored by Bayer · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 1,066
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

To assess a new drug, BAY94-8862, given orally at different doses, to evaluate whether it was safe and can help the well-being of patients with worsening chronic heart failure and either type II diabetes with or without chronic kidney disease or kidney disease alone. These treatment doses were compared to eplerenone, another marketed drug approved to treat heart failure.

Conditions studied

Heart Failure

Browse trials for

Heart Failure 5,803

Keywords

Heart Decompensation

In context

Heart Failure

5,803 studies on the registry are indexed under Heart Failure; 1,222 are open to participants now.

This study's enrollment of 1,066 is above the median of 72 across 3,790 interventional studies indexed under Heart Failure.

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Lead sponsor

Bayer is the lead sponsor of 1,674 studies on the registry; 54 are open to participants now.

Of its 213 completed or terminated interventional studies of FDA-regulated products, 130 (61%) have results posted.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Men and women aged 18 years and older. The lower age limit may be higher if legally required in the participating country
Women of childbearing potential can only be included in the study if a pregnancy test is negative and if they agree to use adequate contraception when sexually active
Subjects with worsening chronic heart failure requiring emergency presentation to hospital and treatment with intravenous diuretics at hospital
Subjects with clinical diagnosis of chronic heart failure (CHF) either ischemic or non ischemic, New York Heart Association (NYHA) functional class II-IV
Subjects with type 2 diabetes mellitus and / or
Subjects with 30 mL/min/1.73m\^2 \</= eGFR \</= 60 mL/min/1.73m\^2 (MDRD, Modification of Diet in Renal Disease Study Group) at screening
Left ventricular ejection fraction (LVEF) \</= 40%
Blood potassium \</= 5.0 mmol/L at screening
Systolic blood pressure >/= 90 mmHg without signs and symptoms of hypotension at the screening visit

Exclusion criteria

Exclusion Criteria:

Acute de-novo heart failure or acute inflammatory heart disease, e.g. acute myocarditis
Acute coronary syndrome (ACS) in last 30 days prior to screening
Cardiogenic shock
Valvular heart disease requiring surgical intervention during the course of the study
Stroke or transient ischemic cerebral attack in the last 3 months prior to the screening visit
Concomitant treatment with any mineralocorticoid receptor antagonist (MRA), renin inhibitor, or potassium-sparing diuretic

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 1,066 participants (actual)

Study arms

Experimental
Finerenone(BAY94-8862)[2.5mg] + Placebo
Oral - 2.5mg once daily (OD) for 30 days. Potential up-titration to 5mg OD after 30 days or 60 days. Treatment duration 90 days. Placebo OD for 90 days.
Drug: Finerenone (BAY94-8862) · Drug: Placebo
Experimental
Finerenone (BAY94-8862)[5mg] + Placebo
Oral - 5mg OD for 30 days. Potential up-titration to 10 mg OD after 30 days or 60 days. Treatment duration 90 days. Placebo OD for 90 days.
Drug: Finerenone (BAY94-8862) · Drug: Placebo
Experimental
Finerenone (BAY94-8862)[7.5mg] + Placebo
Oral - 7.5mg OD for 30 days. Potential up-titration to 15 mg OD after 30 days or 60 days. Treatment duration 90 days. Placebo OD for 90 days.
Drug: Finerenone (BAY94-8862) · Drug: Placebo
Experimental
Finerenone (BAY94-8862)[10mg] + Placebo
Oral - 10mg OD for 30 days. Potential up-titration to 20 mg OD after 30 days or 60 days. Treatment duration 90 days. Placebo OD for 90 days.
Drug: Finerenone (BAY94-8862) · Drug: Placebo
Experimental
Finerenone (BAY94-8862)[15mg] + Placebo
Oral - 15mg OD for 30 days. Potential up-titration to 20 mg OD after 30 days or 60 days. Treatment duration 90 days. Placebo OD for 90 days.
Drug: Finerenone (BAY94-8862) · Drug: Placebo
Active comparator
Eplerenone [25 mg] + Placebo
Oral - 25mg every other day (EOD). Potential up-titration to 25mg OD after 30 days and 50mg OD after 60 days.Placebo OD for 90 days.
Drug: Placebo · Drug: Inspra (eplerenone)

Interventions

What researchers measure

Primary outcomes

Percentage of Participants With a Relative Decrease in NT-proBNP of More Than 30% From Baseline to Day 90
N-terminal pro-B type natriuretic peptide (NT-proBNP) levels in the blood are used for screening, diagnosis of acute and chronic heart failure (CHF) and may be useful to establish prognosis in heart failure.
Time frame: Baseline and Day 90

Secondary outcomes

Number of Participants With Death Due to Any Cause
Death due to any cause include cardiovascular (CV) death and Non-CV death. Non-CV death was classified by 2 subcategories: non-malignant causes and malignant causes.
Time frame: Day 30, Day 60, Day 90 and Follow-up (30 days post-last dose, assessed up to Day 120)
Number of Participants With Cardiovascular Hospitalization
Hospitalizations were defined as any unplanned admission to hospital, i.e. completion of hospital admission procedures and one overnight \[i.e. date change\] stay or until the death of subject occurred. Hospitalizations and deaths were classified by 2 primary categories: CV and non-CV. The pre-specified subcategories for CV hospitalizations were as follows: 1. Worsening heart failure, 2.Acute myocardial infarction, 3. Arrhythmia, 4.Transient ischemic attack and stroke, 5. Other CV hospitalizations.
Time frame: Day 30, Day 60, Day 90 and Follow-up (30 days post-last dose, assessed up to Day 120)
Number of Participants With Emergency Presentations for Worsening Chronic Heart Failure (WCHF)
Emergency presentations for WCHF were defined as newly developing signs and symptoms of WCHF after start of treatment with study drug, requiring an additional emergency presentation to hospital and IV treatment with diuretics and/or positive inotropic agents.
Time frame: Day 30, Day 60, Day 90 and Follow-up (30 days post-last dose, assessed up to Day 120)
Ratio of BNP at Specified Visits to BNP at Baseline
B-type natriuretic peptide (BNP) levels in the blood are used for screening, diagnosis of acute chronic heart failure (CHF) and may be useful to establish prognosis in heart failure.
Time frame: Day 30, Day 60, Day 90, Premature discontinuation (only for participants who have discontinued the study prematurely, to be performed as soon as possible after withdrawal of study drug) and Follow-up (30 days post-last dose, assessed up to Day 120)
Ratio of NT-proBNP at Specified Visits to NT-proBNP at Baseline
N-terminal pro-B type natriuretic peptide (NT-proBNP) levels in the blood are used for screening, diagnosis of acute chronic heart failure (CHF) and may be useful to establish prognosis in heart failure.
Time frame: Day 30, Day 60, Day 90, Premature discontinuation (only for participants who have discontinued the study prematurely, to be performed as soon as possible after withdrawal of study drug) and Follow-up (30 days post-last dose, assessed up to Day 120)
Change From Baseline in KCCQ Questionnaire Scores at Specified Visits
The Kansas City Cardiomyopathy Questionnaire (KCCQ) was the leading health related quality of life measure for subjects with CHF. KCCQ was a 23 item questionnaire that independently measures the impact of subjects HF, or its treatment, on 7 distinct domains: self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. KCCQ clinical summary score is a composite assessment of physical limitations and total symptom scores. Results from the total symptom summary score are presented. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. In the below table, categorical data represents change from baseline data at respective time points.
Time frame: Baseline, Day 30 and Day 90
Change From Baseline in EQ-5D-3L Questionnaire Scores at Specified Visits
EuroQol Group 5-Dimension, 3-Level (EQ-5D-3L): participant rated questionnaire to assess health-related quality of life. It consists of EQ-5D descriptive system and EQ-5D Visual Analog Scale (VAS). EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems (1), some problems (2), and extreme problems (3). For this population, the possible EQ-5D-3L index scores ranges from -0.11 (that is, 3 for all 5 dimensions) to 1.0 (that is, 1 for all 5 dimensions), where higher scores indicate a better health state.
Time frame: Baseline, Day 30, Day 90, Premature discontinuation (only for participants who have discontinued the study prematurely, to be performed as soon as possible after withdrawal of study drug) and Follow-up (30 days post-last dose, assessed up to Day 120)

Other outcomes

Change From Baseline in Serum Potassium at Specified Visits
Time frame: Baseline, Day 30, Day 60, Day 90 and Follow-up (30 days post-last dose, assessed up to Day 120)
Change From Baseline in Systolic Blood Pressure at Specified Visits
Time frame: Baseline,Day 7,14,30,60,90,Premature discontinuation (only for participants who have discontinued the study prematurely, to be performed as soon as possible after withdrawal of study drug) and Follow-up (30 days post-last dose, assessed up to Day 120)
Change From Baseline in Diastolic Blood Pressure at Specified Visits
Time frame: Baseline,Day 7,14,30,60,90,Premature discontinuation (only for participants who have discontinued the study prematurely, to be performed as soon as possible after withdrawal of study drug) and Follow-up (30 days post-last dose, assessed up to Day 120)
Change From Baseline in Heart Rate at Specified Visits
Time frame: Baseline,Day 7,14,30,60,90,Premature discontinuation (only for participants who have discontinued the study prematurely, to be performed as soon as possible after withdrawal of study drug) and Follow-up (30 days post-last dose, assessed up to Day 120)

Results

Posted Jun 15, 2021

Participant flow

Study was conducted in 168 study centers in 25 countries worldwide, from 17 June 2013 (first participant first visit) to 09 December 2014 (last participant last visit).

Participant flow — Overall Study
Milestone	Eplerenone (INSPRA®)	Finerenone (BAY94-8862) 2.5-5 mg OD	Finerenone (BAY94-8862) 5-10 mg OD	Finerenone (BAY94-8862) 7.5-15 mg OD	Finerenone (BAY94-8862) 10-20 mg OD	Finerenone (BAY94-8862) 15-20 mg OD
Started	224	173	165	169	170	165
Participants received study treatment and valid for safety analysis set	221	172	163	167	169	163
Completed	144	121	122	123	134	124
Not completed	80	52	43	46	36	41
Withdrew: Progressive disease	1	0	1	0	0	0
Withdrew: Death	7	9	4	2	1	6
Withdrew: Physician decision	2	1	0	0	0	0
Withdrew: Adverse event	33	22	26	25	18	21
Withdrew: Protocol violation	0	2	1	2	0	1
Withdrew: Non-compliance	1	2	0	1	0	0
Withdrew: Logistical difficulties	0	1	0	0	1	0
Withdrew: Withdrawal by subject	33	15	8	14	16	13
Withdrew: Sponsor decision	2	0	1	1	0	0
Withdrew: Lost to follow-up	1	0	2	1	0	0

Outcome measures

PrimaryPercentage of Participants With a Relative Decrease in NT-proBNP of More Than 30% From Baseline to Day 90

N-terminal pro-B type natriuretic peptide (NT-proBNP) levels in the blood are used for screening, diagnosis of acute and chronic heart failure (CHF) and may be useful to establish prognosis in heart failure.

Time frame:: Baseline and Day 90
Reported as:: Number · Percentage of participants

Percentage of Participants With a Relative Decrease in NT-proBNP of More Than 30% From Baseline to Day 90
Percentage of participants	Eplerenone (INSPRA®)	Finerenone (BAY94-8862) 2.5-5 mg OD	Finerenone (BAY94-8862) 5-10 mg OD	Finerenone (BAY94-8862) 7.5-15 mg OD	Finerenone (BAY94-8862) 10-20 mg OD	Finerenone (BAY94-8862) 15-20 mg OD
Percentage of Participants With a Relative Decrease in NT-proBNP of More Than 30% From Baseline to Day 90	37.2 ± 31.6	30.9 ± 24.9	32.5 ± 26.3	37.3 ± 30.9	38.8 ± 32.3	34.2 ± 27.9

Statistical analysis

Eplerenone (INSPRA®) vs Finerenone (BAY94-8862) 2.5-5 mg OD · Chi-squared · p = 0.8771 · Mean difference (final values): -6.3 · 90% CI -14.9 to 2.3
Eplerenone (INSPRA®) vs Finerenone (BAY94-8862) 5-10 mg OD · Chi-squared · p = 0.7945 · Mean difference (final values): -4.7 · 90% CI -13.4 to 4
Eplerenone (INSPRA®) vs Finerenone (BAY94-8862) 7.5-15 mg OD · Chi-squared · p = 0.5 · Mean difference (final values): 0.1 · 90% CI -8.5 to 8.8
Eplerenone (INSPRA®) vs Finerenone (BAY94-8862) 10-20 mg OD · Chi-squared · p = 0.4225 · Mean difference (final values): 1.6 · 90% CI -7.1 to 10.2
Eplerenone (INSPRA®) vs Finerenone (BAY94-8862) 15-20 mg OD · Chi-squared · p = 0.6865 · Mean difference (final values): -3 · 90% CI -11.7 to 5.7

SecondaryNumber of Participants With Death Due to Any Cause

Death due to any cause include cardiovascular (CV) death and Non-CV death. Non-CV death was classified by 2 subcategories: non-malignant causes and malignant causes.

Time frame:: Day 30, Day 60, Day 90 and Follow-up (30 days post-last dose, assessed up to Day 120)
Reported as:: Count of participants · Participants

Number of Participants With Death Due to Any Cause
Participants	Eplerenone (INSPRA®)	Finerenone (BAY94-8862) 2.5-5 mg OD	Finerenone (BAY94-8862) 5-10 mg OD	Finerenone (BAY94-8862) 7.5-15 mg OD	Finerenone (BAY94-8862) 10-20 mg OD	Finerenone (BAY94-8862) 15-20 mg OD
Day 30	6	5	1	1	0	2
Day 60	7	7	3	2	0	4
Day 90	9	10	4	4	1	5
Follow-up	15	16	7	11	2	8

SecondaryNumber of Participants With Cardiovascular Hospitalization

Hospitalizations were defined as any unplanned admission to hospital, i.e. completion of hospital admission procedures and one overnight \[i.e. date change\] stay or until the death of subject occurred. Hospitalizations and deaths were classified by 2 primary categories: CV and non-CV. The pre-specified subcategories for CV hospitalizations were as follows: 1. Worsening heart failure, 2.Acute myocardial infarction, 3. Arrhythmia, 4.Transient ischemic attack and stroke, 5. Other CV hospitalizations.

Time frame:: Day 30, Day 60, Day 90 and Follow-up (30 days post-last dose, assessed up to Day 120)
Reported as:: Count of participants · Participants

Number of Participants With Cardiovascular Hospitalization
Participants	Eplerenone (INSPRA®)	Finerenone (BAY94-8862) 2.5-5 mg OD	Finerenone (BAY94-8862) 5-10 mg OD	Finerenone (BAY94-8862) 7.5-15 mg OD	Finerenone (BAY94-8862) 10-20 mg OD	Finerenone (BAY94-8862) 15-20 mg OD
Day 30	28	23	14	8	7	15
Day 60	43	33	23	21	15	23
Day 90	45	35	26	29	22	28
Follow-up	56	43	38	36	27	34

SecondaryNumber of Participants With Emergency Presentations for Worsening Chronic Heart Failure (WCHF)

Emergency presentations for WCHF were defined as newly developing signs and symptoms of WCHF after start of treatment with study drug, requiring an additional emergency presentation to hospital and IV treatment with diuretics and/or positive inotropic agents.

Time frame:: Day 30, Day 60, Day 90 and Follow-up (30 days post-last dose, assessed up to Day 120)
Reported as:: Count of participants · Participants

Number of Participants With Emergency Presentations for Worsening Chronic Heart Failure (WCHF)
Participants	Eplerenone (INSPRA®)	Finerenone (BAY94-8862) 2.5-5 mg OD	Finerenone (BAY94-8862) 5-10 mg OD	Finerenone (BAY94-8862) 7.5-15 mg OD	Finerenone (BAY94-8862) 10-20 mg OD	Finerenone (BAY94-8862) 15-20 mg OD
Day 30	21	19	12	9	7	15
Day 60	35	30	20	17	14	22
Day 90	37	32	22	24	18	28
Follow-up	47	40	30	30	26	34

SecondaryRatio of BNP at Specified Visits to BNP at Baseline

B-type natriuretic peptide (BNP) levels in the blood are used for screening, diagnosis of acute chronic heart failure (CHF) and may be useful to establish prognosis in heart failure.

Time frame:: Day 30, Day 60, Day 90, Premature discontinuation (only for participants who have discontinued the study prematurely, to be performed as soon as possible after withdrawal of study drug) and Follow-up (30 days post-last dose, assessed up to Day 120)
Reported as:: Geometric mean · Ratio

Ratio of BNP at Specified Visits to BNP at Baseline
Ratio	Eplerenone (INSPRA®)	Finerenone (BAY94-8862) 2.5-5 mg OD	Finerenone (BAY94-8862) 5-10 mg OD	Finerenone (BAY94-8862) 7.5-15 mg OD	Finerenone (BAY94-8862) 10-20 mg OD	Finerenone (BAY94-8862) 15-20 mg OD
Day 30	0.925 ± 2.02	0.944 ± 1.952	0.878 ± 1.713	0.832 ± 1.959	0.852 ± 1.901	0.879 ± 1.968
Day 60	0.783 ± 2.194	0.864 ± 2.139	0.854 ± 1.854	0.79 ± 2.179	0.711 ± 2.116	0.824 ± 2.142
Day 90	0.723 ± 2.202	0.813 ± 2.412	0.839 ± 1.93	0.719 ± 2.204	0.706 ± 2.34	0.771 ± 2.197
Premature discontinuation	0.896 ± 0.896	1.104 ± 2.15	1.006 ± 2.422	0.884 ± 1.973	0.848 ± 2.218	1.044 ± 2.174
Follow-up	0.795 ± 2.232	0.815 ± 2.388	0.886 ± 2.199	0.726 ± 2.397	0.729 ± 2.487	0.852 ± 2.169

SecondaryRatio of NT-proBNP at Specified Visits to NT-proBNP at Baseline

N-terminal pro-B type natriuretic peptide (NT-proBNP) levels in the blood are used for screening, diagnosis of acute chronic heart failure (CHF) and may be useful to establish prognosis in heart failure.

Time frame:: Day 30, Day 60, Day 90, Premature discontinuation (only for participants who have discontinued the study prematurely, to be performed as soon as possible after withdrawal of study drug) and Follow-up (30 days post-last dose, assessed up to Day 120)
Reported as:: Geometric mean · Ratio

Ratio of NT-proBNP at Specified Visits to NT-proBNP at Baseline
Ratio	Eplerenone (INSPRA®)	Finerenone (BAY94-8862) 2.5-5 mg OD	Finerenone (BAY94-8862) 5-10 mg OD	Finerenone (BAY94-8862) 7.5-15 mg OD	Finerenone (BAY94-8862) 10-20 mg OD	Finerenone (BAY94-8862) 15-20 mg OD
Day 30	0.883 ± 2.458	0.98 ± 2.158	0.874 ± 2.14	0.888 ± 2.123	0.822 ± 2.217	0.921 ± 2.136
Day 60	0.749 ± 2.73	0.822 ± 2.423	0.814 ± 2.178	0.81 ± 2.268	0.748 ± 2.496	0.829 ± 2.288
Day 90	0.688 ± 2.59	0.789 ± 2.661	0.765 ± 2.214	0.783 ± 2.454	0.728 ± 2.795	0.771 ± 2.471
Premature discontinuation	0.948 ± 2.684	1.369 ± 2.087	1.267 ± 2.261	0.927 ± 1.864	1.133 ± 2.981	0.965 ± 2.352
Follow-up	0.747 ± 2.616	0.747 ± 2.741	0.887 ± 2.604	0.809 ± 2.647	0.746 ± 2.472	0.849 ± 2.348

SecondaryChange From Baseline in KCCQ Questionnaire Scores at Specified Visits

The Kansas City Cardiomyopathy Questionnaire (KCCQ) was the leading health related quality of life measure for subjects with CHF. KCCQ was a 23 item questionnaire that independently measures the impact of subjects HF, or its treatment, on 7 distinct domains: self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. KCCQ clinical summary score is a composite assessment of physical limitations and total symptom scores. Results from the total symptom summary score are presented. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. In the below table, categorical data represents change from baseline data at respective time points.

Time frame:: Baseline, Day 30 and Day 90
Reported as:: Mean · Scores on a scale

Change From Baseline in KCCQ Questionnaire Scores at Specified Visits
Scores on a scale	Eplerenone (INSPRA®)	Finerenone (BAY94-8862) 2.5-5 mg OD	Finerenone (BAY94-8862) 5-10 mg OD	Finerenone (BAY94-8862) 7.5-15 mg OD	Finerenone (BAY94-8862) 10-20 mg OD	Finerenone (BAY94-8862) 15-20 mg OD
Baseline	43.7 ± 23	42.8 ± 22.6	45.4 ± 24	42.1 ± 23.2	42.3 ± 23.7	43.2 ± 22.5
Day 30	20.5 ± 26.2	18.2 ± 22.7	19.3 ± 26.5	23 ± 24.4	24.9 ± 22.9	20.6 ± 27
Day 90	24.3 ± 27.6	21.3 ± 27.2	24.5 ± 27	29.3 ± 28.6	28.3 ± 23.8	22.2 ± 30.6

SecondaryChange From Baseline in EQ-5D-3L Questionnaire Scores at Specified Visits

EuroQol Group 5-Dimension, 3-Level (EQ-5D-3L): participant rated questionnaire to assess health-related quality of life. It consists of EQ-5D descriptive system and EQ-5D Visual Analog Scale (VAS). EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems (1), some problems (2), and extreme problems (3). For this population, the possible EQ-5D-3L index scores ranges from -0.11 (that is, 3 for all 5 dimensions) to 1.0 (that is, 1 for all 5 dimensions), where higher scores indicate a better health state.

Time frame:: Baseline, Day 30, Day 90, Premature discontinuation (only for participants who have discontinued the study prematurely, to be performed as soon as possible after withdrawal of study drug) and Follow-up (30 days post-last dose, assessed up to Day 120)
Reported as:: Mean · Scores on scale

Change From Baseline in EQ-5D-3L Questionnaire Scores at Specified Visits
Scores on scale	Eplerenone (INSPRA®)	Finerenone (BAY94-8862) 2.5-5 mg OD	Finerenone (BAY94-8862) 5-10 mg OD	Finerenone (BAY94-8862) 7.5-15 mg OD	Finerenone (BAY94-8862) 10-20 mg OD	Finerenone (BAY94-8862) 15-20 mg OD
Baseline	0.58 ± 0.25	0.59 ± 0.25	0.62 ± 0.23	0.58 ± 0.23	0.56 ± 0.25	0.59 ± 0.24
Day 30	0.06 ± 0.23	0.02 ± 0.24	0.02 ± 0.23	0.07 ± 0.22	0.06 ± 0.23	0.02 ± 0.25
Day 90	0.08 ± 0.24	0.03 ± 0.27	0.04 ± 0.25	0.08 ± 0.2	0.1 ± 0.24	0.06 ± 0.28
Premature discontinuation	-0.12 ± 0.25	-0.06 ± 0.29	-0.09 ± 0.24	-0.1 ± 0.24	-0.05 ± 0.25	0 ± 0.29
Follow-up	0.06 ± 0.26	0.01 ± 0.25	0.01 ± 0.27	0.08 ± 0.23	0.07 ± 0.23	0.04 ± 0.28

Other pre-specifiedChange From Baseline in Serum Potassium at Specified Visits

Time frame:: Baseline, Day 30, Day 60, Day 90 and Follow-up (30 days post-last dose, assessed up to Day 120)
Reported as:: Mean · millimoles per liter (mmol/L)

Change From Baseline in Serum Potassium at Specified Visits
millimoles per liter (mmol/L)	Eplerenone (INSPRA®)	Finerenone (BAY94-8862) 2.5-5 mg OD	Finerenone (BAY94-8862) 5-10 mg OD	Finerenone (BAY94-8862) 7.5-15 mg OD	Finerenone (BAY94-8862) 10-20 mg OD	Finerenone (BAY94-8862) 15-20 mg OD
Baseline	4.159 ± 0.495	4.081 ± 0.501	4.211 ± 0.541	4.174 ± 0.443	4.131 ± 0.506	4.117 ± 0.506
Day 30	0.057 ± 0.608	0.135 ± 0.573	0.075 ± 0.523	0.085 ± 0.475	0.21 ± 0.592	0.193 ± 0.556
Day 60	0.179 ± 0.589	0.091 ± 0.568	0.131 ± 0.566	0.171 ± 0.54	0.274 ± 0.522	0.216 ± 0.547
Day 90	0.307 ± 0.609	0.184 ± 0.574	0.153 ± 0.516	0.164 ± 0.579	0.275 ± 0.58	0.245 ± 0.574
Follow-up	0.117 ± 0.621	0.226 ± 0.694	0.054 ± 0.623	0.05 ± 0.572	0.175 ± 0.559	0.036 ± 0.556

Other pre-specifiedChange From Baseline in Systolic Blood Pressure at Specified Visits

Time frame:: Baseline,Day 7,14,30,60,90,Premature discontinuation (only for participants who have discontinued the study prematurely, to be performed as soon as possible after withdrawal of study drug) and Follow-up (30 days post-last dose, assessed up to Day 120)
Reported as:: Mean · millimeter of mercury (mmHg)

Change From Baseline in Systolic Blood Pressure at Specified Visits
millimeter of mercury (mmHg)	Eplerenone (INSPRA®)	Finerenone (BAY94-8862) 2.5-5 mg OD	Finerenone (BAY94-8862) 5-10 mg OD	Finerenone (BAY94-8862) 7.5-15 mg OD	Finerenone (BAY94-8862) 10-20 mg OD	Finerenone (BAY94-8862) 15-20 mg OD
Baseline	120.554 ± 18.706	119.492 ± 16.348	118.498 ± 14.355	119.087 ± 16.677	116.024 ± 16.895	116.941 ± 16.548
Day 7	-0.541 ± 13.894	-3.178 ± 13.72	-2.565 ± 12.278	0.568 ± 12.733	0.162 ± 15.416	-0.546 ± 13.498
Day 14	-3.442 ± 14.258	-4.488 ± 10.31	4.142 ± 15.001	1.241 ± 13.561	-3.099 ± 12.591	-2.906 ± 15.406
Day 30	0.067 ± 15.312	-0.824 ± 15.747	-0.367 ± 14.984	0.374 ± 14.433	1.786 ± 15.039	0.899 ± 14.608
Day 60	0.684 ± 16.315	0.337 ± 14.176	-1.249 ± 13.659	-1.811 ± 14.462	0.981 ± 15.525	0.667 ± 14.83
Day 90	-0.967 ± 16.408	0.922 ± 15.847	0.047 ± 15.643	-0.664 ± 15.018	1.216 ± 17.831	0.956 ± 15.743
Premature discontinuation	-2.991 ± 16.456	-0.41 ± 13.936	-2.167 ± 19.963	9.391 ± 22.378	-2.32 ± 11.963	-0.028 ± 15.42
Follow-up	0.188 ± 16.751	2.869 ± 15.502	1.95 ± 16.148	-0.928 ± 17.953	2.041 ± 16.189	3.037 ± 16.782

Other pre-specifiedChange From Baseline in Diastolic Blood Pressure at Specified Visits

Time frame:: Baseline,Day 7,14,30,60,90,Premature discontinuation (only for participants who have discontinued the study prematurely, to be performed as soon as possible after withdrawal of study drug) and Follow-up (30 days post-last dose, assessed up to Day 120)
Reported as:: Mean · millimeter for mercury (mmHg)

Change From Baseline in Diastolic Blood Pressure at Specified Visits
millimeter for mercury (mmHg)	Eplerenone (INSPRA®)	Finerenone (BAY94-8862) 2.5-5 mg OD	Finerenone (BAY94-8862) 5-10 mg OD	Finerenone (BAY94-8862) 7.5-15 mg OD	Finerenone (BAY94-8862) 10-20 mg OD	Finerenone (BAY94-8862) 15-20 mg OD
Baseline	71.633 ± 11.647	71.044 ± 10.762	71.442 ± 8.508	70.61 ± 9.692	70.343 ± 10.394	71.145 ± 9.809
Day 7	-1.351 ± 10.237	-1.693 ± 9.911	-2.143 ± 9.848	0.013 ± 9.733	-0.738 ± 10.534	-1.166 ± 8.964
Day 14	-3.442 ± 10.089	-0.537 ± 9.59	1.608 ± 9.423	-0.083 ± 7.421	-2.387 ± 10.51	-0.625 ± 9.41
Day 30	-0.503 ± 10.826	0.146 ± 10.667	-0.845 ± 8.91	-0.068 ± 9.633	-0.094 ± 10.086	-1.163 ± 9.622
Day 60	-0.613 ± 11.096	-0.199 ± 11.297	-2.144 ± 9.552	-0.85 ± 10.472	0.17 ± 10.312	-0.575 ± 10.427
Day 90	-0.716 ± 11.035	-0.106 ± 11.148	-1.738 ± 9.015	-1.121 ± 9.96	-0.545 ± 11.212	-0.877 ± 11.327
Premature discontinuation	-3.185 ± 11.853	0.868 ± 9.239	-2.194 ± 15.522	4.101 ± 12.151	-2.96 ± 9.199	-0.083 ± 10.113
Follow-up	-1.218 ± 11.477	0.696 ± 13.172	-0.444 ± 10.197	-1.16 ± 11.114	-0.298 ± 11.521	-0.172 ± 10.211

Other pre-specifiedChange From Baseline in Heart Rate at Specified Visits

Time frame:: Baseline,Day 7,14,30,60,90,Premature discontinuation (only for participants who have discontinued the study prematurely, to be performed as soon as possible after withdrawal of study drug) and Follow-up (30 days post-last dose, assessed up to Day 120)
Reported as:: Mean · Beats per minute (Beats/min)

Change From Baseline in Heart Rate at Specified Visits
Beats per minute (Beats/min)	Eplerenone (INSPRA®)	Finerenone (BAY94-8862) 2.5-5 mg OD	Finerenone (BAY94-8862) 5-10 mg OD	Finerenone (BAY94-8862) 7.5-15 mg OD	Finerenone (BAY94-8862) 10-20 mg OD	Finerenone (BAY94-8862) 15-20 mg OD
Baseline	74.957 ± 13.813	73.369 ± 13.396	72.681 ± 12.623	74.184 ± 12.369	73.852 ± 11.999	74.329 ± 13.187
Day 7	-0.8 ± 10.751	1.073 ± 13.5	-0.63 ± 11.696	-0.719 ± 10.77	-0.548 ± 11.144	-1.176 ± 13.398
Day 14	-3.109 ± 15.101	0.599 ± 16.387	1.842 ± 14.988	-1.324 ± 13.666	0.423 ± 11.247	-3.969 ± 13.715
Day 30	0.294 ± 13.61	1.064 ± 14.128	0.435 ± 13.63	-0.349 ± 12.636	-0.802 ± 11.311	-1.633 ± 12.719
Day 60	0.297 ± 13.033	-0.975 ± 14.953	-1.741 ± 10.86	-2.318 ± 14.225	0.192 ± 13.377	-1.608 ± 13.828
Day 90	-0.189 ± 12.289	-1.647 ± 13.001	-2.89 ± 12.034	-2.212 ± 12.041	-0.71 ± 13.777	-1.145 ± 14.284
Premature discontinuation	-2.278 ± 15.909	-1.424 ± 15.587	-0.222 ± 7.591	1.101 ± 10.22	4.733 ± 13.646	-2.072 ± 19.731
Follow-up	-1.281 ± 13.789	-2.057 ± 13.982	-0.626 ± 14.196	-1.326 ± 15.488	0.834 ± 14.159	-1.317 ± 14.636

Adverse events

Collected over Adverse events: from the start of study treatment until 3 days post-last dose, up to approximately 93 days. All Cause Mortality: assessed until 30 days post-last dose, up to approximately 120 days.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Eplerenone (INSPRA®)	19/221 (8.6%)	77/221 (34.8%)	85/221 (38.5%)
Finerenone(BAY94-8862) 2.5-5 mg OD	17/172 (9.9%)	72/172 (41.9%)	63/172 (36.6%)
Finerenone (BAY94-8862) 5-10 mg OD	9/163 (5.5%)	47/163 (28.8%)	59/163 (36.2%)
Finerenone (BAY94-8862) 7.5-15 mg OD	12/167 (7.2%)	52/167 (31.1%)	50/167 (29.9%)
Finerenone (BAY94-8862) 10-20 mg OD	2/169 (1.2%)	46/169 (27.2%)	50/169 (29.6%)
Finerenone (BAY94-8862) 15-20 mg OD	9/163 (5.5%)	57/163 (35%)	65/163 (39.9%)

Most frequent serious events

Showing 10 of 172

Most frequent serious events
Event	Eplerenone (INSPRA®)	Finerenone(BAY94-8862) 2.5-5 mg OD	Finerenone (BAY94-8862) 5-10 mg OD	Finerenone (BAY94-8862) 7.5-15 mg OD	Finerenone (BAY94-8862) 10-20 mg OD	Finerenone (BAY94-8862) 15-20 mg OD
Cardiac failureCardiac disorders	21/221	16/172	15/163	21/167	11/169	13/163
Cardiac failure chronicCardiac disorders	13/221	9/172	7/163	8/167	6/169	12/163
HyperkalaemiaMetabolism and nutrition disorders	5/221	6/172	4/163	7/167	5/169	6/163
Cardiac failure acuteCardiac disorders	6/221	6/172	3/163	1/167	3/169	5/163
Cardiac failure congestiveCardiac disorders	4/221	5/172	2/163	2/167	0/169	3/163
Renal failure acuteRenal and urinary disorders	0/221	5/172	1/163	4/167	2/169	1/163
Ventricular tachycardiaCardiac disorders	2/221	4/172	0/163	3/167	1/169	1/163
PneumoniaInfections and infestations	1/221	3/172	3/163	1/167	2/169	3/163
Renal failure chronicRenal and urinary disorders	0/221	0/172	1/163	2/167	0/169	3/163
Ventricular fibrillationCardiac disorders	3/221	3/172	0/163	0/167	0/169	0/163

Most frequent other events

Most frequent other events
Event	Eplerenone (INSPRA®)	Finerenone(BAY94-8862) 2.5-5 mg OD	Finerenone (BAY94-8862) 5-10 mg OD	Finerenone (BAY94-8862) 7.5-15 mg OD	Finerenone (BAY94-8862) 10-20 mg OD	Finerenone (BAY94-8862) 15-20 mg OD
HypokalaemiaMetabolism and nutrition disorders	34/221	20/172	21/163	15/167	14/169	17/163
Cardiac failureCardiac disorders	13/221	14/172	10/163	5/167	7/169	10/163
DyspnoeaRespiratory, thoracic and mediastinal disorders	11/221	12/172	7/163	6/167	3/169	10/163
HypotensionVascular disorders	11/221	7/172	11/163	11/167	7/169	8/163
DiarrhoeaGastrointestinal disorders	8/221	6/172	6/163	10/167	6/169	7/163
HyperkalaemiaMetabolism and nutrition disorders	8/221	5/172	7/163	7/167	6/169	9/163
Renal impairmentRenal and urinary disorders	8/221	6/172	7/163	6/167	8/169	9/163
Blood creatinine increasedInvestigations	12/221	5/172	7/163	3/167	4/169	8/163
DizzinessNervous system disorders	12/221	8/172	6/163	6/167	7/169	6/163
NauseaGastrointestinal disorders	7/221	9/172	2/163	5/167	2/169	6/163

Baseline characteristics

Safety analysis set (SAF): all randomized participants who took at least one dose of study drug and with data after beginning of treatment.

Age, Continuous
Age, Continuous(years)	Eplerenone (INSPRA®)	Finerenone (BAY94-8862) 2.5-5 mg OD	Finerenone (BAY94-8862) 5-10 mg OD	Finerenone (BAY94-8862) 7.5-15 mg OD	Finerenone (BAY94-8862) 10-20 mg OD	Finerenone (BAY94-8862) 15-20 mg OD	Total
Mean	72.38 ± 9.92	72.53 ± 9.74	71.81 ± 10.55	69.27 ± 9.83	71.27 ± 10.27	69.2 ± 10.15	71.15 ± 10.14

Sex: Female, Male
Sex: Female, Male(Participants)	Eplerenone (INSPRA®)	Finerenone (BAY94-8862) 2.5-5 mg OD	Finerenone (BAY94-8862) 5-10 mg OD	Finerenone (BAY94-8862) 7.5-15 mg OD	Finerenone (BAY94-8862) 10-20 mg OD	Finerenone (BAY94-8862) 15-20 mg OD	Total
Female	51	37	37	43	41	31	240
Male	170	135	126	124	128	132	815

Baseline BNP
Baseline BNP(pg/ml)	Eplerenone (INSPRA®)	Finerenone (BAY94-8862) 2.5-5 mg OD	Finerenone (BAY94-8862) 5-10 mg OD	Finerenone (BAY94-8862) 7.5-15 mg OD	Finerenone (BAY94-8862) 10-20 mg OD	Finerenone (BAY94-8862) 15-20 mg OD	Total
Geometric mean	594.290 ± 2.601	677.906 ± 2.637	574.245 ± 2.543	570.776 ± 2.741	606.080 ± 2.598	552.032 ± 2.698	594.732 ± 2.634

Baseline NT-proBNP
Baseline NT-proBNP(pg/ml)	Eplerenone (INSPRA®)	Finerenone (BAY94-8862) 2.5-5 mg OD	Finerenone (BAY94-8862) 5-10 mg OD	Finerenone (BAY94-8862) 7.5-15 mg OD	Finerenone (BAY94-8862) 10-20 mg OD	Finerenone (BAY94-8862) 15-20 mg OD	Total
Geometric mean	4730.170 ± 2.938	4793.430 ± 3.084	4184.631 ± 3.093	3776.859 ± 3.395	4163.898 ± 2.734	3791.677 ± 3.013	4246.883 ± 3.040

Study locations

172 sites

Birmingham, Alabama 35294-2041, United States
La Jolla, California 92037, United States
Los Angeles, California 90033, United States
Jacksonville, Florida 32209, United States
Macon, Georgia 31201, United States
Baltimore, Maryland 21201, United States
Detroit, Michigan 48201, United States
Detroit, Michigan 48202, United States
Newark, New Jersey 07103, United States
Fairfield, Ohio 45014, United States
Darlinghurst, New South Wales 2010, Australia
Adelaide, South Australia 5042, Australia
Concord, 2139, Australia
Prahran, 3004, Australia
Krems, Lower Austria 3500, Austria
Graz, Styria 8020, Austria
Graz, Styria 8036, Austria
Innsbruck, Tyrol 6020, Austria
Linz, Upper Austria 4010, Austria
Salzburg, 5020, Austria
Vienna, 1100, Austria
Burgas, 8018, Bulgaria
Pazardzhik, 4400, Bulgaria
Rousse, 7002, Bulgaria
Sofia, 1233, Bulgaria
Sofia, 1309, Bulgaria
Sofia, 1431, Bulgaria
Varna, 9010, Bulgaria
Calgary, Alberta T2N 4Z6, Canada
Ottawa, Ontario K1Y 4W7, Canada
Toronto, Ontario M5B 1W8, Canada
Montreal, Quebec H1T 1C8, Canada
Montreal, Quebec H2W 1T8, Canada
Montreal, Quebec H3T 1E2, Canada
Saint-Jean-sur-Richelieu, Quebec J3A 1C3, Canada
Sherbrooke, Quebec J1H 5N4, Canada
Québec, G1V 4G5, Canada
Jindřichův Hradec, 377 01, Czechia
Ostrava, 728 80, Czechia
Prague, 150 30, Czechia
Slaný, 274 01, Czechia
Copenhagen Ø, 2100, Denmark
Esbjerg, 6700, Denmark
Glostrup Municipality, 2600, Denmark
Hellerup, 2900, Denmark
Herlev, 2730, Denmark
Hvidovre, 2650, Denmark
København NV, 2400, Denmark
Køge, 4600, Denmark
Svendborg, 5700, Denmark
Viborg, 8800, Denmark
Espoo, 02740, Finland
Helsinki, 00099, Finland
Rovaniemi, 96101, Finland
Turku, 20520, Finland
Bron, 69677, France
Nice, 06200, France
Paris, 75013, France
Paris, 75475, France
Rouen, 76031, France
Toulouse, 31403, France
Vandœuvre-lès-Nancy, 54500, France
Würzburg, Bavaria 97078, Germany
Frankfurt am Main, Hesse 60389, Germany
Limburg an der Lahn, Hesse 65549, Germany
Göttingen, Lower Saxony 37099, Germany
Hanover, Lower Saxony 30625, Germany
Stade, Lower Saxony 21682, Germany
Bad Oeynhausen, North Rhine-Westphalia 32545, Germany
Mönchengladbach, North Rhine-Westphalia 41063, Germany
Homburg, Saarland 66421, Germany
Erfurt, Thuringia 99089, Germany
Berlin, 13353, Germany
Athens, 11526, Greece
Athens, 11527, Greece
Chaïdári, 12462, Greece
Larissa, 41100, Greece
Nea Ionia / Athens, 14233, Greece
Budapest, 1027, Hungary
Budapest, 1085, Hungary
Budapest, 1097, Hungary
Nagykanizsa, 8800, Hungary
Székesfehérvár, 8000, Hungary
Afula, 1834111, Israel
Ashkelon, 7830604, Israel
Hadera, 3810101, Israel
Haifa, 3436212, Israel
Jerusalem, 9103102, Israel
Kfar Saba, 4428164, Israel
Nahariya, 2210001, Israel
Petah Tikva, 4941492, Israel
Rehovot, 7610001, Israel
Safed, 1311001, Israel
Tel Aviv, 64239, Israel
Ẕerifin, 7030000, Israel
Foggia, Apulia 71100, Italy
Rome, Lazio 00163, Italy
Bergamo, Lombardy 24127, Italy
Milan, Lombardy 20149, Italy
Monza Brianza, Lombardy 20900, Italy

Showing the first 100 of 172 sites across 25 countries.

References and documents

Publications

Filippatos G, Anker SD, Bohm M, Gheorghiade M, Kober L, Krum H, Maggioni AP, Ponikowski P, Voors AA, Zannad F, Kim SY, Nowack C, Palombo G, Kolkhof P, Kimmeskamp-Kirschbaum N, Pieper A, Pitt B. A randomized controlled study of finerenone vs. eplerenone in patients with worsening chronic heart failure and diabetes mellitus and/or chronic kidney disease. Eur Heart J. 2016 Jul 14;37(27):2105-14. doi: 10.1093/eurheartj/ehw132. Epub 2016 Apr 29. PubMed 27130705 ↗
Chung EY, Ruospo M, Natale P, Bolignano D, Navaneethan SD, Palmer SC, Strippoli GF. Aldosterone antagonists in addition to renin angiotensin system antagonists for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev. 2020 Oct 27;10(10):CD007004. doi: 10.1002/14651858.CD007004.pub4. PubMed 33107592 ↗
Pitt B, Anker SD, Bohm M, Gheorghiade M, Kober L, Krum H, Maggioni AP, Ponikowski P, Voors AA, Zannad F, Nowack C, Kim SY, Pieper A, Kimmeskamp-Kirschbaum N, Filippatos G. Rationale and design of MinerAlocorticoid Receptor antagonist Tolerability Study-Heart Failure (ARTS-HF): a randomized study of finerenone vs. eplerenone in patients who have worsening chronic heart failure with diabetes and/or chronic kidney disease. Eur J Heart Fail. 2015 Feb;17(2):224-32. doi: 10.1002/ejhf.218. PubMed 25678098 ↗
Ostrominski JW, Filippatos G, Claggett BL, Miao ZM, Desai AS, Jhund PS, Henderson A, Rohwedder K, Brinker MD, Scalise A, Schloemer P, Lam CSP, Senni M, Shah SJ, Voors AA, Zannad F, Rossing P, Ruilope LM, Anker SD, Pitt B, Agarwal R, McMurray JJV, Solomon SD, Vaduganathan M. Effect of Finerenone on Morbidity and Mortality in CKD. J Am Soc Nephrol. 2026 Feb 1;37(2):312-325. doi: 10.1681/ASN.0000000823. Epub 2025 Sep 12. PubMed 40938666 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 6, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01807221
Lead sponsor: Bayer
Responsible party: Sponsor
First posted: Mar 8, 2013
Start date: Jun 17, 2013
Primary completion: Nov 11, 2014
Completion: Dec 9, 2014
Results posted: Jun 15, 2021
Last update: Jul 6, 2021

Study contacts

Bayer Study Director

study director · Bayer

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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