Clinical Trials List
Protocol NumberBAY 94-8862/ 20103
NCT Number(ClinicalTrials.gov Identfier)NCT04435626
2020-03-17 - 2024-05-02
Phase III
Not yet recruiting2
Recruiting6
ICD-10I50.9
Heart failure, unspecified
A multicenter, randomized, double-blind, parallelgroup, placebo-controlled study to evaluate the efficacy and safety of finerenone on morbidity and mortality in participants with heart failure (NYHA II-IV) and left ventricular ejection fraction >= 40%. (LVEF >= 40%)
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Trial Applicant
BAYER TAIWAN COMPANY LTD.
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Sponsor
Bayer
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- WEI-WEN LIN 無
- 王奇彥 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 吳韋璁 無
- Chun-Yuan Chu 無
- Po-Chao Hsu 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- LIAN-YU LIN 無
- 張博淵 無
- 黃惠君 無
- JEN-KUANG LEE 無
- 洪啟盛 無
- 賀立婷 無
- 林柏志 無
- WEN-JONE CHEN 無
- 黃慶昌 無
- CHO-KAI WU 無
- HUNG-JU LIN 無
- 陳盈憲 無
- 江君揚 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chun-Ming Shih 無
- Chien-Yi Hsu 無
- 蕭卜源 無
- Tsung-Lin Yang 無
- 陳志維 無
- Yung-Ta Kao 無
- Wei-Fung Bi 無
- Kuang-Hsing Chiang 無
- 蕭成儀 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Taipei Veterans General Hospital
Taiwan National PI
江晨恩
Co-Principal Investigator
- Tse-Min Lu 無
- Wen-Chung Yu 無
- 黃少嵩 無
- Shih-Hsien Sung 無
- Kang-Ling Wang 無
- Hao-min Cheng 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
heart failure
Objectives
Primary
-To demonstrate the superiority of finerenone to placebo in reducing the rate of the composite CV endpoint
Secondary
-To determine superiority of finerenone to placebo for each secondary endpoint
-To assess the safety and tolerability of finerenone
Test Drug
Finerenone/ BAY 94-8862
Active Ingredient
C21H22N4O3
Dosage Form
tablet
Dosage
10mg/ 20mg/ 40mg
Endpoints
Composite primary endpoint:
Cardiovascular (CV) death and total (first and recurrent) HF events (HHF or urgent HF visit) in HF patients (New York Heart Association [NYHA] class II–IV) and LVEF ≥40%.
Secondary endpoints:
Change from baseline to Month 6, 9 and 12 in Total Symptom Score (TSS) of the KCCQ
Time to first occurrence of composite renal endpoint:
sustained decrease in estimated glomerular filtration rate (eGFR) ≥40% relative to baseline over at least 4 weeks, or
sustained eGFR decline <15ml/min/1.73m2 or initiation of dialysis or renal transplantation.
Time to all-cause mortality
Cardiovascular (CV) death and total (first and recurrent) HF events (HHF or urgent HF visit) in HF patients (New York Heart Association [NYHA] class II–IV) and LVEF ≥40%.
Secondary endpoints:
Change from baseline to Month 6, 9 and 12 in Total Symptom Score (TSS) of the KCCQ
Time to first occurrence of composite renal endpoint:
sustained decrease in estimated glomerular filtration rate (eGFR) ≥40% relative to baseline over at least 4 weeks, or
sustained eGFR decline <15ml/min/1.73m2 or initiation of dialysis or renal transplantation.
Time to all-cause mortality
Inclution Criteria
Participants are eligible to be included in the study only if all of the following criteria apply:
Age
1. Participant must be aged 40 years and older, at the time of signing the informed
consent.
Type of Participant and Disease Characteristics:
2. Diagnosis of heart failure with NYHA class II–IV, ambulatory or hospitalized
primarily for heart failure (if a hospitalized patient cannot be randomized as an
in-patient, randomization as soon as possible after discharge is encouraged)
3. Treated with diuretics within 30 days prior to randomization
4. Documented LVEF of ≥40% measured by any modality within the last 12 months, at
the latest at screening; if several values are available, the most recent one shall be
reported. If LVEF was not measured in the past 12 months, a new measurement may
be done at screening
5. Structural heart abnormalities based on any local imaging measurement within the last
12 months, latest at screening, defined by at least 1 of the following findings:
o LAD ≥3.8cm, LAA ≥20cm2, LAVI >30 mL/m2, LVMI ≥115 g/m2 (♂) /
95 g/m2 (♀), septal thickness or posterior wall thickness ≥1.1 cm
6. NT-proBNP ≥300 pg/mL (BNP ≥100 pg/mL) in sinus rhythm or
NT-proBNP ≥900pg/mL (BNP ≥300 pg/mL) in atrial fibrillation (or if atrial fibrillation
status is unknown; see Section 4.1) for participants 1 obtained at the following time:
o Within 90 days prior to randomization if patient had been hospitalized for HF
requiring initiation or change in HF therapy or if patient had an urgent visit for HF
requiring intravenous (IV) diuretic therapy, both within 90 days prior to randomization
OR
o Within 30 days prior to randomization if patient has not been hospitalized for HF
nor had an urgent HF visit within the past 90 days.
Sex
7. Male or female.
Women of childbearing potential can only be included in the study if a pregnancy
test is negative at screening and baseline and if they agree to use adequate
contraception which is consistent with local regulations regarding the methods for
contraception for those participating in clinical trials.
Informed Consent
8. Capable of giving signed informed consent as described in Section 10.1.3 which
includes compliance with the requirements and restrictions listed in the informed
consent form (ICF) and in this protocol.
Age
1. Participant must be aged 40 years and older, at the time of signing the informed
consent.
Type of Participant and Disease Characteristics:
2. Diagnosis of heart failure with NYHA class II–IV, ambulatory or hospitalized
primarily for heart failure (if a hospitalized patient cannot be randomized as an
in-patient, randomization as soon as possible after discharge is encouraged)
3. Treated with diuretics within 30 days prior to randomization
4. Documented LVEF of ≥40% measured by any modality within the last 12 months, at
the latest at screening; if several values are available, the most recent one shall be
reported. If LVEF was not measured in the past 12 months, a new measurement may
be done at screening
5. Structural heart abnormalities based on any local imaging measurement within the last
12 months, latest at screening, defined by at least 1 of the following findings:
o LAD ≥3.8cm, LAA ≥20cm2, LAVI >30 mL/m2, LVMI ≥115 g/m2 (♂) /
95 g/m2 (♀), septal thickness or posterior wall thickness ≥1.1 cm
6. NT-proBNP ≥300 pg/mL (BNP ≥100 pg/mL) in sinus rhythm or
NT-proBNP ≥900pg/mL (BNP ≥300 pg/mL) in atrial fibrillation (or if atrial fibrillation
status is unknown; see Section 4.1) for participants 1 obtained at the following time:
o Within 90 days prior to randomization if patient had been hospitalized for HF
requiring initiation or change in HF therapy or if patient had an urgent visit for HF
requiring intravenous (IV) diuretic therapy, both within 90 days prior to randomization
OR
o Within 30 days prior to randomization if patient has not been hospitalized for HF
nor had an urgent HF visit within the past 90 days.
Sex
7. Male or female.
Women of childbearing potential can only be included in the study if a pregnancy
test is negative at screening and baseline and if they agree to use adequate
contraception which is consistent with local regulations regarding the methods for
contraception for those participating in clinical trials.
Informed Consent
8. Capable of giving signed informed consent as described in Section 10.1.3 which
includes compliance with the requirements and restrictions listed in the informed
consent form (ICF) and in this protocol.
Exclusion Criteria
Exclusion Criteria
Participants are excluded from the study if any of the following criteria apply:
Medical Conditions
1. eGFR <25 mL/min/1.73 m² at either screening or randomization visit.
NOTE: one reassessment of eGFR is allowed at the screening and randomization visit,
respectively
2. Serum/plasma potassium >5.0 mmol/L at either screening or randomization visit.
NOTE: one reassessment of potassium is allowed at the screening and randomization visit,
respectively
3. Acute inflammatory heart disease, e.g. acute myocarditis, within 90 days prior to
randomization
4. Myocardial infarction or any event which could have reduced the ejection fraction
within 90 days prior to randomization
5. Coronary artery bypass graft surgery in the 90 days prior to randomization
6. Percutaneous coronary intervention in the 30 days prior to randomization
7. Stroke or transient ischemic cerebral attack within 90 days prior to randomization
8. Probable alternative cause of participants’ HF symptoms that in the opinion of the
investigator primarily accounts for patient’s dyspnea such as significant pulmonary
disease, anemia or obesity. Specifically, patients with the below are excluded:
Severe pulmonary disease requiring home oxygen, or chronic oral steroid therapy
History of primary pulmonary arterial hypertension
Hemoglobin <10 g/dl
Valvular heart disease considered by the investigator to be clinically significant
Body mass index (BMI) >50 kg/m2 at screening
9. Systolic blood pressure (SBP) ≥160 mmHg if not on treatment with ≥3 blood pressure
lowering medications or ≥180 mmHg irrespective of treatments, on 2 consecutive
measurements at least 2-minute apart, at screening or at randomization
10. Life-threatening or uncontrolled arrhythmias at screening and/or randomization
including but not limited to sustained ventricular tachycardia and atrial fibrillation,
or atrial flutter with resting ventricular rate >110 bpm
11. Symptomatic hypotension with mean systolic blood pressure <90 mmHg at screening
or at randomization
12. Any primary cause of HF scheduled for surgery, e.g. valve disease such as severe
aortic stenosis or severe mitral regurgitation by the time of screening or randomization
13. History of peripartum cardiomyopathy, chemotherapy induced cardiomyopathy,
viral myocarditis, right heart failure in absence of left-sided structural disease,
pericardial constriction, genetic hypertrophic cardiomyopathy, or infiltrative
cardiomyopathy including amyloidosis
14. Presence of left ventricular assist device by the time of screening or randomization
15. History of hyperkalemia or acute renal failure during MRA treatment for
>7 consecutive days, leading to permanent discontinuation of the MRA treatment
16. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a
female after conception and until the termination of gestation, confirmed by a positive
human chorionic gonadotrophin urine or serum test
17. Known hypersensitivity to the study intervention (active substance or excipients)
18. Hepatic insufficiency classified as Child-Pugh C at screening or randomization
19. Addison’s disease.
Prior/Concomitant Therapy
20. Requirement of any IV vasodilating drug (e.g. nitrates, nitroprusside), any IV
natriuretic peptide (e.g. nesiritide, carperitide), any IV positive inotropic agents, or
mechanical support (intra-aortic balloon pump, endotracheal intubation, mechanical
ventilation, or any ventricular assist device) within 24 hours prior to randomization
21. Participants who require treatment with more than one ACEI, ARB or
angiotensin-receptor neprilysin inhibitor (ARNI), or two simultaneously at
randomization
22. Continuous (at least 90 days) treatment with an MRA (e.g. spironolactone, eplerenone,
canrenone, esaxerenone) within 12 months prior to screening. Last intake at least
30 days before randomization. Treatment with MRA should not be interrupted with
the purpose of enrollment into the study
23. Concomitant treatment with any renin inhibitor or potassium-sparing diuretic that
cannot be stopped prior to randomization and for the duration of the treatment period
24. Concomitant systemic therapy with potent cytochrome P450 isoenzyme 3A4 (CYP3A4)
inhibitors or inducers that cannot be discontinued 7 days prior to randomization and
for the duration of the treatment period (e.g. itraconazole, ritonavir, indinavir,
cobicistat, clarithromycin).
Other Exclusions
25. Any other condition or therapy, which would make the participant unsuitable for this
study and will not allow participation for the full planned study period (e.g. active
malignancy or other condition limiting life expectancy to less than 12 months)
26. Previous assignment to treatment during this study
27. Participation in another interventional clinical study (e.g. Phase 1 to 3 clinical studies)
or treatment with another investigational medicinal product within 30 days prior to
randomization
28. Close affiliation with the investigational site; e.g. a close relative of the investigator,
dependent person (e.g. employee or student of the investigational site)
29. Known current alcohol and/or illicit drug abuse that may interfere with the
participant’s safety and/or compliance at the discretion of the investigator
30. Participant is in custody by order of an authority or a court of law.
Participants are excluded from the study if any of the following criteria apply:
Medical Conditions
1. eGFR <25 mL/min/1.73 m² at either screening or randomization visit.
NOTE: one reassessment of eGFR is allowed at the screening and randomization visit,
respectively
2. Serum/plasma potassium >5.0 mmol/L at either screening or randomization visit.
NOTE: one reassessment of potassium is allowed at the screening and randomization visit,
respectively
3. Acute inflammatory heart disease, e.g. acute myocarditis, within 90 days prior to
randomization
4. Myocardial infarction or any event which could have reduced the ejection fraction
within 90 days prior to randomization
5. Coronary artery bypass graft surgery in the 90 days prior to randomization
6. Percutaneous coronary intervention in the 30 days prior to randomization
7. Stroke or transient ischemic cerebral attack within 90 days prior to randomization
8. Probable alternative cause of participants’ HF symptoms that in the opinion of the
investigator primarily accounts for patient’s dyspnea such as significant pulmonary
disease, anemia or obesity. Specifically, patients with the below are excluded:
Severe pulmonary disease requiring home oxygen, or chronic oral steroid therapy
History of primary pulmonary arterial hypertension
Hemoglobin <10 g/dl
Valvular heart disease considered by the investigator to be clinically significant
Body mass index (BMI) >50 kg/m2 at screening
9. Systolic blood pressure (SBP) ≥160 mmHg if not on treatment with ≥3 blood pressure
lowering medications or ≥180 mmHg irrespective of treatments, on 2 consecutive
measurements at least 2-minute apart, at screening or at randomization
10. Life-threatening or uncontrolled arrhythmias at screening and/or randomization
including but not limited to sustained ventricular tachycardia and atrial fibrillation,
or atrial flutter with resting ventricular rate >110 bpm
11. Symptomatic hypotension with mean systolic blood pressure <90 mmHg at screening
or at randomization
12. Any primary cause of HF scheduled for surgery, e.g. valve disease such as severe
aortic stenosis or severe mitral regurgitation by the time of screening or randomization
13. History of peripartum cardiomyopathy, chemotherapy induced cardiomyopathy,
viral myocarditis, right heart failure in absence of left-sided structural disease,
pericardial constriction, genetic hypertrophic cardiomyopathy, or infiltrative
cardiomyopathy including amyloidosis
14. Presence of left ventricular assist device by the time of screening or randomization
15. History of hyperkalemia or acute renal failure during MRA treatment for
>7 consecutive days, leading to permanent discontinuation of the MRA treatment
16. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a
female after conception and until the termination of gestation, confirmed by a positive
human chorionic gonadotrophin urine or serum test
17. Known hypersensitivity to the study intervention (active substance or excipients)
18. Hepatic insufficiency classified as Child-Pugh C at screening or randomization
19. Addison’s disease.
Prior/Concomitant Therapy
20. Requirement of any IV vasodilating drug (e.g. nitrates, nitroprusside), any IV
natriuretic peptide (e.g. nesiritide, carperitide), any IV positive inotropic agents, or
mechanical support (intra-aortic balloon pump, endotracheal intubation, mechanical
ventilation, or any ventricular assist device) within 24 hours prior to randomization
21. Participants who require treatment with more than one ACEI, ARB or
angiotensin-receptor neprilysin inhibitor (ARNI), or two simultaneously at
randomization
22. Continuous (at least 90 days) treatment with an MRA (e.g. spironolactone, eplerenone,
canrenone, esaxerenone) within 12 months prior to screening. Last intake at least
30 days before randomization. Treatment with MRA should not be interrupted with
the purpose of enrollment into the study
23. Concomitant treatment with any renin inhibitor or potassium-sparing diuretic that
cannot be stopped prior to randomization and for the duration of the treatment period
24. Concomitant systemic therapy with potent cytochrome P450 isoenzyme 3A4 (CYP3A4)
inhibitors or inducers that cannot be discontinued 7 days prior to randomization and
for the duration of the treatment period (e.g. itraconazole, ritonavir, indinavir,
cobicistat, clarithromycin).
Other Exclusions
25. Any other condition or therapy, which would make the participant unsuitable for this
study and will not allow participation for the full planned study period (e.g. active
malignancy or other condition limiting life expectancy to less than 12 months)
26. Previous assignment to treatment during this study
27. Participation in another interventional clinical study (e.g. Phase 1 to 3 clinical studies)
or treatment with another investigational medicinal product within 30 days prior to
randomization
28. Close affiliation with the investigational site; e.g. a close relative of the investigator,
dependent person (e.g. employee or student of the investigational site)
29. Known current alcohol and/or illicit drug abuse that may interfere with the
participant’s safety and/or compliance at the discretion of the investigator
30. Participant is in custody by order of an authority or a court of law.
The Estimated Number of Participants
-
Taiwan
116 participants
-
Global
6900 participants
