check_circleStudy Completed

Heart Failure

Bayer Identifier:

14564

ClinicalTrials.gov Identifier:

NCT01807221

EudraCT Number:

2012-002627-15

EU CT Number:

Not Available
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

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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 - Left ventricular ejection fraction (LVEF) - Blood potassium - Systolic blood pressure >/= 90 mmHg without signs and symptoms of hypotension at the screening visit
  • - 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

Trial summary

Enrollment Goal
1066
Trial Dates
June 2013 - December 2014
Phase
Phase 2
Could I Receive a placebo
Yes
Products
Finerenone (BAY94-8862)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Espoo, 02740, Finland
Completed
Helsinki, 00099, Finland
Completed
Turku, 20520, Finland
Withdrawn
Jyväskylä, 40620, Finland
Completed
Rovaniemi, 96101, Finland
Completed
Rouen, 76031, France
Completed
TOULOUSE, 31403, France
Completed
Paris cedex 13, 75013, France
Completed
Bron, 69677, France
Withdrawn
CRETEIL, 94000, France
Completed
PARIS cedex 10, 75475, France
Completed
Vandoeuvre les Nancy, 54500, France
Completed
Hannover, 30625, Germany
Completed
Berlin, 13353, Germany
Completed
Homburg, 66421, Germany
Completed
Mönchengladbach, 41063, Germany
Completed
Erfurt, 99089, Germany
Completed
Vilnius, LT-08661, Lithuania
Completed
Kaunas, LT-50161, Lithuania
Completed
Kaunas, LT-44320, Lithuania
Completed
Kaunas, LT-47144, Lithuania
Completed
Klaipeda, LT-92288, Lithuania
Completed
Klaipeda, 92288, Lithuania
Completed
Chaidari, 12462, Greece
Completed
Athens, 11526, Greece
Completed
Athens, 11527, Greece
Completed
Göttingen, 37099, Germany
Withdrawn
Bochum, 44789, Germany
Completed
Copenhagen Ø, 2100, Denmark
Completed
Hellerup, 2900, Denmark
Completed
København NV, 2400, Denmark
Completed
Hvidovre, 2650, Denmark
Completed
Herlev, 2730, Denmark
Completed
Svendborg, 5700, Denmark
Withdrawn
Odense, 5000, Denmark
Completed
Køge, 4600, Denmark
Completed
Viborg, 8800, Denmark
Completed
Bergamo, 24127, Italy
Completed
Monza Brianza, 20900, Italy
Completed
Milano, 20149, Italy
Completed
Foggia, 71100, Italy
Completed
Roma, 00163, Italy
Completed
Arezzo, 52044, Italy
Completed
Würzburg, 97078, Germany
Completed
Bad Oeynhausen, 32545, Germany
Completed
Stavanger, 4011, Norway
Withdrawn
Haugesund, 5504, Norway
Withdrawn
Tønsberg, 3116, Norway
Completed
Wien, 1100, Austria
Withdrawn
Wien, 1160, Austria
Completed
Salzburg, 5020, Austria
Completed
Krems an der Donau, 3500, Austria
Completed
Linz, 4010, Austria
Completed
El Palmar, 30120, Spain
Completed
Göteborg, 416 85, Sweden
Completed
Stockholm, 118 83, Sweden
Completed
Stockholm, 141 86, Sweden
Completed
Stockholm, 182 88, Sweden
Completed
Örebro, 701 85, Sweden
Completed
Falun, 791 82, Sweden
Completed
Umeå, 901 85, Sweden
Completed
Pisa, 56124, Italy
Completed
Graz, 8020, Austria
Completed
Graz, 8036, Austria
Withdrawn
Bodø, 8092, Norway
Withdrawn
Tromsø, 9038, Norway
Completed
Perugia, 06129, Italy
Completed
Detroit, 48201, United States
Completed
Detroit, 48202, United States
Completed
Innsbruck, 6020, Austria
Completed
Valencia, 46010, Spain
Completed
Valencia, 46026, Spain
Completed
Madrid, 28041, Spain
Completed
Barcelona, 08035, Spain
Completed
Toronto, M5B 1W8, Canada
Withdrawn
Victoria, V8R 4R2, Canada
Withdrawn
Vancouver, V5Z 1M9, Canada
Completed
Sherbrooke, J1H 5N4, Canada
Completed
Ottawa, K1Y 4W7, Canada
Withdrawn
St-Charles-Borromee, J6E 6J2, Canada
Completed
Montreal, H3T 1E2, Canada
Completed
Montreal, H1T 1C8, Canada
Withdrawn
Cambridge, N1R 6V6, Canada
Completed
Saint-Jean-sur-Richelieu, J3A 1C3, Canada
Withdrawn
Hamilton, L8L 2X2, Canada
Completed
Calgary, T2N 4Z6, Canada
Completed
Esbjerg, 6700, Denmark
Completed
Barcelona, 08003, Spain
Completed
Seoul, 05505, Korea, Republic Of
Completed
Seoul, 03080, Korea, Republic Of
Completed
Wonju, 26426, Korea, Republic Of
Completed
Petoria, South Africa
Completed
Tongaat, 4400, South Africa
Completed
Merebank, 4052, South Africa
Completed
Somerset West, 7130, South Africa
Completed
Worcester, 6850, South Africa
Completed
Pinelands, 7405, South Africa
Completed
Isipingo Rail, 4110, South Africa
Completed
Kuils River, 7580, South Africa
Completed
Cape Town, 7500, South Africa
Completed
Somerset West, 7130, South Africa
Completed
Zefat, 1311001, Israel
Completed
Ashkelon, 7830604, Israel
Completed
Petach Tikva, 4941492, Israel
Completed
Rehovot, 7610001, Israel
Completed
Hadera, 3810101, Israel
Completed
Tel Aviv, 64239, Israel
Completed
Afula, 1834111, Israel
Completed
Jerusalem, 9103102, Israel
Completed
Haifa, 3436212, Israel
Completed
Nahariya, 2210001, Israel
Completed
Kfar Saba, 4428164, Israel
Completed
Zerifin, 7030000, Israel
Withdrawn
Atlanta, 30308, United States
Withdrawn
San Francisco, 94143, United States
Completed
Macon, 31201, United States
Completed
Olot, 17800, Spain
Withdrawn
Liberec, 46063, Czechia
Withdrawn
Plzen - Bory, 305 99, Czechia
Completed
Praha 5, 150 30, Czechia
Withdrawn
New Orleans, 70112, United States
Completed
Majadahonda, 28222, Spain
Completed
Szekesfehervar, 8000, Hungary
Completed
Budapest, 1027, Hungary
Completed
Budapest, 1097, Hungary
Completed
Budapest, 1085, Hungary
Completed
Nagykanizsa, 8800, Hungary
Completed
Stade, 21682, Germany
Withdrawn
Philadelphia, 19107, United States
Withdrawn
Petoskey, 49770-2297, United States
Withdrawn
Valasske Mezirici, 757 42, Czechia
Completed
Ostrava, 728 80, Czechia
Completed
Jindrichuv Hradec, 377 01, Czechia
Completed
Baltimore, 21201, United States
Completed
Wroclaw, 50-981, Poland
Completed
Krakow, 31-121, Poland
Completed
Bydgoszcz, 85-681, Poland
Completed
Szczecin, 70-965, Poland
Completed
Gdansk, 80-952, Poland
Completed
Newark, 07103, United States
Completed
La Jolla, 92037, United States
Completed
GRONINGEN, 9700 RB, Netherlands
Completed
NIJMEGEN, 6525 GA, Netherlands
Completed
GRONINGEN, 9728 NT, Netherlands
Completed
VELDHOVEN, 5504 DB, Netherlands
Completed
AMSTERDAM, 1061 AE, Netherlands
Completed
ROTTERDAM, 3045 PM, Netherlands
Completed
DELFT, 2625 AD, Netherlands
Completed
HOOGEVEEN, 7909 AA, Netherlands
Completed
Prahran, 3004, Australia
Withdrawn
Herston, 4029, Australia
Completed
Adelaide, 5042, Australia
Completed
Concord, 2139, Australia
Withdrawn
Geelong, 3220, Australia
Completed
Porto, P-4200, Portugal
Completed
Lisboa, 1500-650, Portugal
Completed
Almada, 2801-951, Portugal
Completed
Lisboa, 1449-005, Portugal
Completed
Lisboa, 1649-035, Portugal
Completed
Faro, 8000-386, Portugal
Completed
Taipei, 11217, Taiwan
Completed
Taipei, 100, Taiwan
Completed
Taipei, Taiwan
Completed
Taizung, 402, Taiwan
Completed
Jacksonville, 32209, United States
Withdrawn
New Orleans, 70121, United States
Completed
Los Angeles, 90033, United States
Withdrawn
Hickory, 28601, United States
Completed
Warszawa, 04-628, Poland
Completed
Katowice, 40-635, Poland
Withdrawn
Warszawa, 02-005, Poland
Completed
Kielce, 25-736, Poland
Completed
Bialystok, 15-276, Poland
Completed
ZUTPHEN, 7207 AE, Netherlands
Completed
Ruse, 7002, Bulgaria
Completed
Varna, 9010, Bulgaria
Completed
Pazardzhik, 4400, Bulgaria
Completed
Sofia, 1309, Bulgaria
Completed
Sofia, 1431, Bulgaria
Completed
Sofia, 1233, Bulgaria
Completed
Quebec, G1V 4G5, Canada
Completed
DARLINGHURST, 2010, Australia
Completed
Burgas, 8018, Bulgaria
Completed
Nea Ionia / Athens, 14233, Greece
Completed
Larissa, 41100, Greece
Completed
Birmingham, 35294-2041, United States
Completed
Slany, 274 01, Czechia
Withdrawn
Brno, 63600, Czechia
Completed
NICE, 06200, France
Completed
Frankfurt, 60389, Germany
Withdrawn
Seoul, 06591, Korea, Republic Of
Completed
Seoul, 03722, Korea, Republic Of
Completed
New Taipei City, 220, Taiwan
Completed
Ankara, 06100, Turkey
Withdrawn
Mainz, 55131, Germany
Completed
Ankara, 06500, Turkey
Withdrawn
Izmir, 35100, Turkey
Completed
Izmir, 35100, Turkey
Completed
Ankara, Turkey
Completed
Antalya, 07003, Turkey
Completed
Fairfield, 45014, United States
Completed
Glostrup, 2600, Denmark
Completed
Montreal, H2W 1T8, Canada
Withdrawn
Ft. Lauderdale, 33308, United States
Completed
Limburg, 65549, Germany

Primary Outcome

  • 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.
    date_rangeTime Frame:
    Baseline and Day 90

Secondary Outcome

  • 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.
    date_rangeTime 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.
    date_rangeTime 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.
    date_rangeTime 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.
    date_rangeTime 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.
    date_rangeTime 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.
    date_rangeTime 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.
    date_rangeTime 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)

Trial design

A randomized, double-blind, double-dummy, multi-center study to assess safety and efficacy of different oral doses of BAY94-8862 in subjects with emergency presentation at the hospital because of worsening chronic heart failure with left ventricular systolic dysfunction and either type 2 diabetes mellitus with or without chronic kidney disease or chronic kidney disease alone versus eplerenone
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
6

Additional Information

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