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 (ARTS-HF)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Bayer
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01807221
First received: March 7, 2013
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

To assess a new drug, BAY94-8862, given orally at different doses, to evaluate whether it is 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 will be compared to eplerenone, another marketed drug approved to treat heart failure.


Condition Intervention Phase
Heart Failure
Drug: Finerenone (BAY94-8862)
Drug: Placebo
Drug: Inspra (eplerenone)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Relative decrease in N-terminal prohormone B-type natriuretic peptide (NT-proBNP) [ Time Frame: From baseline to 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in serum potassium [ Time Frame: From baseline to 90 days ] [ Designated as safety issue: Yes ]
  • Change in blood pressure [ Time Frame: From baseline to 90 days ] [ Designated as safety issue: Yes ]
  • Change in heart rate [ Time Frame: From baseline to 90 days ] [ Designated as safety issue: Yes ]
  • Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: Up to 120 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1060
Study Start Date: June 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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/1.73m2 </= eGFR </= 60 mL/min/1.73m2 (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:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01807221

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com
Contact: For trial location information (Phone Menu Options '3' or '4') (+)1-888-84 22937

  Hide Study Locations
Locations
United States, Alabama
Recruiting
Birmingham, Alabama, United States, 35294-2041
United States, California
Recruiting
La Jolla, California, United States, 92037
Recruiting
Los Angeles, California, United States, 90033
Not yet recruiting
San Francisco, California, United States, 94143
United States, Florida
Not yet recruiting
Ft. Lauderdale, Florida, United States, 33308
Recruiting
Jacksonville, Florida, United States, 32209
United States, Georgia
Not yet recruiting
Atlanta, Georgia, United States, 30308
Recruiting
Macon, Georgia, United States, 31201
United States, Louisiana
Not yet recruiting
New Orleans, Louisiana, United States, 70112
Not yet recruiting
New Orleans, Louisiana, United States, 70121
United States, Maryland
Recruiting
Baltimore, Maryland, United States, 21201
United States, Michigan
Recruiting
Detroit, Michigan, United States, 48201
Recruiting
Detroit, Michigan, United States, 48202
Terminated
Petoskey, Michigan, United States, 49770-2297
United States, New Jersey
Recruiting
Newark, New Jersey, United States, 07103
United States, North Carolina
Terminated
Hickory, North Carolina, United States, 28601
United States, Ohio
Recruiting
Fairfield, Ohio, United States, 45014
United States, Pennsylvania
Not yet recruiting
Philadelphia, Pennsylvania, United States, 19107
Australia, New South Wales
Recruiting
Darlinghurst, New South Wales, Australia, 2010
Australia, South Australia
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Adelaide, South Australia, Australia, 5043
Australia
Recruiting
Concord, Australia, 2139
Not yet recruiting
Geelong, Australia, 3220
Not yet recruiting
Herston, Australia, 4029
Recruiting
Prahran, Australia, 3004
Austria
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Krems an der Donau, Niederösterreich, Austria, 3500
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Linz, Oberösterreich, Austria, 4010
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Graz, Steiermark, Austria, 8020
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Graz, Steiermark, Austria, 8036
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Innsbruck, Tirol, Austria, 6020
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Salzburg, Austria, 5020
Terminated
Wien, Austria, 1160
Recruiting
Wien, Austria, 1100
Bulgaria
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Burgas, Bulgaria, 8018
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Pazardjik, Bulgaria, 4400
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Ruse, Bulgaria, 7002
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Sofia, Bulgaria, 1309
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Sofia, Bulgaria, 1431
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Sofia, Bulgaria, 1233
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Varna, Bulgaria, 9010
Canada, Alberta
Recruiting
Calgary, Alberta, Canada, T2N 4Z6
Canada, British Columbia
Not yet recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Terminated
Victoria, British Columbia, Canada, V8R 4R2
Canada, Ontario
Terminated
Cambridge, Ontario, Canada, N1R 6V6
Not yet recruiting
Hamilton, Ontario, Canada, L8L 2X2
Recruiting
Ottawa, Ontario, Canada, K1Y 4W7
Recruiting
Toronto, Ontario, Canada, M5B 1W8
Canada, Quebec
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Montreal, Quebec, Canada, H1T 1C8
Recruiting
Montreal, Quebec, Canada, H3T 1E2
Not yet recruiting
Montreal, Quebec, Canada, H2W 1T8
Recruiting
Saint-Jean-sur-Richelieu, Quebec, Canada, J3A 1C3
Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Terminated
St-Charles-Borromee, Quebec, Canada, J6E 6J2
Canada
Recruiting
Quebec, Canada, G1V 4G5
Czech Republic
Not yet recruiting
Brno, Czech Republic, 63600
Recruiting
Jindrichuv Hradec, Czech Republic, 377 01
Terminated
Liberec, Czech Republic, 46063
Recruiting
Ostrava, Czech Republic, 728 80
Terminated
Plzen - Bory, Czech Republic, 305 99
Recruiting
Praha 5, Czech Republic, 150 30
Recruiting
Slany, Czech Republic, 274 01
Not yet recruiting
Valasske Mezirici, Czech Republic, 757 42
Denmark
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Copenhagen Ø, Denmark, 2100
Recruiting
Esbjerg, Denmark, 6700
Not yet recruiting
Glostrup, Denmark, 2600
Recruiting
Hellerup, Denmark, 2900
Recruiting
Herlev, Denmark, 2730
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Hvidovre, Denmark, 2650
Recruiting
København NV, Denmark, 2400
Recruiting
Køge, Denmark, 4600
Terminated
Odense, Denmark, 5000
Recruiting
Svendborg, Denmark, 5700
Recruiting
Viborg, Denmark, 8800
Finland
Recruiting
Espoo, Finland, 02740
Recruiting
Helsinki, Finland, 00099
Not yet recruiting
Jyväskylä, Finland, 40620
Recruiting
Rovaniemi, Finland, 96101
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Turku, Finland, 20520
France
Recruiting
Bron, France, 69677
Terminated
Creteil, France, 94000
Recruiting
Nice, France, 06200
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PARIS cedex 10, France, 75475
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Paris cedex 13, France, 75013
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Rouen, France, 76031
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Toulouse, France, 31403
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Vandoeuvre les Nancy, France, 54500
Germany
Recruiting
Würzburg, Bayern, Germany, 97078
Recruiting
Frankfurt, Hessen, Germany, 60389
Not yet recruiting
Limburg, Hessen, Germany, 65549
Recruiting
Göttingen, Niedersachsen, Germany, 37075
Recruiting
Hannover, Niedersachsen, Germany, 30625
Recruiting
Stade, Niedersachsen, Germany, 21682
Recruiting
Bad Oeynhausen, Nordrhein-Westfalen, Germany, 32545
Not yet recruiting
Bochum, Nordrhein-Westfalen, Germany, 44789
Recruiting
Mönchengladbach, Nordrhein-Westfalen, Germany, 41063
Not yet recruiting
Mainz, Rheinland-Pfalz, Germany, 55131
Recruiting
Homburg, Saarland, Germany, 66421
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Erfurt, Thüringen, Germany, 99089
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Berlin, Germany, 13353
Greece
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Athens, Attica, Greece, 11527
Recruiting
Haidari, Attica, Greece, 12462
Recruiting
Larissa, Greece, 41111
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Nea Ionia / Athens, Greece, 14233
Hungary
Recruiting
Budapest, Hungary, 1027
Recruiting
Budapest, Hungary, H-1096
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Budapest, Hungary, 1089
Recruiting
Nagykanizsa, Hungary, 8800
Recruiting
Szekesfehervar, Hungary, 8000
Israel
Recruiting
Afula, Israel, 1834111
Recruiting
Ashkelon, Israel, 7830604
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Hadera, Israel, 3810101
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Haifa, Israel, 34362
Recruiting
Jerusalem, Israel, 9372212
Recruiting
Kfar Saba, Israel, 4428164
Recruiting
Nahariya, Israel, 22100
Recruiting
Petach Tikva, Israel, 4941492
Recruiting
Rehovot, Israel, 7610001
Completed
Safed, Israel, 1311001
Recruiting
Tel Aviv, Israel, 64239
Recruiting
Zerifin, Israel, 6093000
Italy
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Cortona, Arezzo, Italy, 52040
Recruiting
Bergamo, Italy, 24127
Recruiting
Foggia, Italy, 71100
Recruiting
Milano, Italy, 20149
Recruiting
Monza, Italy, 20090
Recruiting
Perugia, Italy, 06156
Recruiting
Pisa, Italy, 56124
Recruiting
Roma, Italy, 00163
Korea, Republic of
Recruiting
Wonju-si, Gang''weondo, Korea, Republic of, 220-701
Recruiting
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 110-744
Recruiting
Seoul, Korea, Republic of, 138-736
Not yet recruiting
Seoul, Korea, Republic of, 137-701
Recruiting
Seoul, Korea, Republic of, 120-752
Lithuania
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Kaunas, Lithuania, LT-50009
Recruiting
Kaunas, Lithuania, LT-47144
Recruiting
Kaunas, Lithuania, LT-44320
Recruiting
Klaipeda, Lithuania, 92288
Recruiting
Klaipeda, Lithuania, LT-92288
Recruiting
Vilnius, Lithuania, LT-08661
Netherlands
Recruiting
Amsterdam, Netherlands, 1061 AE
Recruiting
Delft, Netherlands, 2625 AD
Recruiting
Groningen, Netherlands, 9728 NT
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Groningen, Netherlands, 9700 RB
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Hoogeveen, Netherlands, 7909 AA
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Nijmegen, Netherlands, 6525 GA
Recruiting
Rotterdam, Netherlands, 3045 PM
Recruiting
Veldhoven, Netherlands, 5504 DB
Recruiting
Zutphen, Netherlands, 7207 AE
Norway
Not yet recruiting
Bodø, Norway, 8092
Terminated
Haugesund, Norway, 5504
Recruiting
Stavanger, Norway, 4011
Terminated
Tromsø, Norway, 9038
Terminated
Tønsberg, Norway, 3116
Poland
Recruiting
Bialystok, Poland, 15-276
Recruiting
Bydgoszcz, Poland, 85-681
Recruiting
Gdansk, Poland, 80-952
Recruiting
Katowice, Poland, 40-635
Recruiting
Kielce, Poland, 25-736
Recruiting
Krakow, Poland, 31-121
Recruiting
Szczecin, Poland, 70-965
Terminated
Warszawa, Poland, 02-005
Recruiting
Warszawa, Poland, 04-628
Recruiting
Wroclaw, Poland, 50-981
Portugal
Recruiting
Almada, Portugal, 2801-951
Recruiting
Faro, Portugal, 8000-386
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Lisboa, Portugal, 1449-005
Recruiting
Lisboa, Portugal, 1500-650
Recruiting
Lisboa, Portugal, 1649-035
Recruiting
Porto, Portugal, P-4200
South Africa
Recruiting
Petoria, Gauteng, South Africa
Recruiting
Isipingo Rail, Kwazulu-Natal, South Africa, 4110
Recruiting
Merebank, Kwazulu-Natal, South Africa, 4052
Recruiting
Tongaat, Kwazulu-Natal, South Africa, 4400
Recruiting
Cape Town, Western Cape, South Africa, 7500
Recruiting
Kuils River, Western Cape, South Africa, 7580
Recruiting
Pinelands, Western Cape, South Africa, 7405
Recruiting
Somerset West, Western Cape, South Africa, 7130
Recruiting
Worcester, Western Cape, South Africa, 6850
Spain
Recruiting
Olot, Girona, Spain, 17800
Recruiting
Majadahonda, Madrid, Spain, 28222
Recruiting
El Palmar, Murcia, Spain, 30120
Recruiting
Barcelona, Spain, 08003
Recruiting
Barcelona, Spain, 08035
Recruiting
Madrid, Spain, 28041
Recruiting
Valencia, Spain, 46010
Recruiting
Valencia, Spain, 46026
Sweden
Recruiting
Falun, Sweden, 791 82
Recruiting
Göteborg, Sweden, 416 85
Recruiting
Stockholm, Sweden, 141 86
Recruiting
Stockholm, Sweden, 118 83
Recruiting
Stockholm, Sweden, 182 88
Recruiting
Umeå, Sweden, 901 85
Recruiting
Örebro, Sweden, 701 85
Taiwan
Recruiting
New Taipei City, Taiwan, 220
Recruiting
Taipei, Taiwan
Recruiting
Taipei, Taiwan, 100
Recruiting
Taipei, Taiwan, 11217
Recruiting
Taizung, Taiwan, 402
Turkey
Recruiting
Ankara, Turkey, 06100
Recruiting
Ankara, Turkey, 06500
Not yet recruiting
Ankara, Turkey
Recruiting
Antalya, Turkey, 07003
Recruiting
Izmir, Turkey, 35100
Not yet recruiting
Izmir, Turkey, 35100
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01807221     History of Changes
Other Study ID Numbers: 14564, 2012-002627-15
Study First Received: March 7, 2013
Last Updated: July 21, 2014
Health Authority: Austria: Austrian Medicines and Medical Devices Agency
Australia: Department of Health and Ageing Therapeutic Goods Administration
Canada: Health Canada
Czech Republic: State Institute for Drug Control
Denmark: Danish Health and Medicines Authority
Finland: Finnish Medicines Agency
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Germany: Federal Institute for Drugs and Medical Devices
Greece: National Organization of Medicines
Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines
Israel: Ministry of Health
Italy: The Italian Medicines Agency
Lithuania: State Medicine Control Agency - Ministry of Health
Netherlands: Medicines Evaluation Board (MEB)
Norway: Norwegian Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Portugal: INFARMED - National Authority of Medicines and Health Products
South Africa: Medicines Control Council
South Korea: Korea Food and Drug Administration (KFDA)
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Sweden: Medical Products Agency
United States: Food and Drug Administration
Taiwan : Food and Drug Administration

Keywords provided by Bayer:
Heart Decompensation

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Heart Failure
Kidney Diseases
Renal Insufficiency, Chronic
Ventricular Dysfunction, Left
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases
Urologic Diseases
Renal Insufficiency
Ventricular Dysfunction
Eplerenone
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 31, 2014