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 ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01807221
First received: March 7, 2013
Last updated: September 26, 2014
Last verified: September 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 ]

Enrollment: 1058
Study Start Date: June 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: November 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

  Hide Study Locations
Locations
United States, Alabama
Birmingham, Alabama, United States, 35294-2041
United States, California
La Jolla, California, United States, 92037
Los Angeles, California, United States, 90033
San Francisco, California, United States, 94143
United States, Florida
Ft. Lauderdale, Florida, United States, 33308
Jacksonville, Florida, United States, 32209
United States, Georgia
Atlanta, Georgia, United States, 30308
Macon, Georgia, United States, 31201
United States, Louisiana
New Orleans, Louisiana, United States, 70112
New Orleans, Louisiana, United States, 70121
United States, Maryland
Baltimore, Maryland, United States, 21201
United States, Michigan
Detroit, Michigan, United States, 48202
Detroit, Michigan, United States, 48201
Petoskey, Michigan, United States, 49770-2297
United States, New Jersey
Newark, New Jersey, United States, 07103
United States, North Carolina
Hickory, North Carolina, United States, 28601
United States, Ohio
Fairfield, Ohio, United States, 45014
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19107
Australia, New South Wales
Darlinghurst, New South Wales, Australia, 2010
Australia, South Australia
Adelaide, South Australia, Australia, 5043
Australia
Concord, Australia, 2139
Geelong, Australia, 3220
Herston, Australia, 4029
Prahran, Australia, 3004
Austria
Krems an der Donau, Niederösterreich, Austria, 3500
Linz, Oberösterreich, Austria, 4010
Graz, Steiermark, Austria, 8020
Graz, Steiermark, Austria, 8036
Innsbruck, Tirol, Austria, 6020
Salzburg, Austria, 5020
Wien, Austria, 1100
Wien, Austria, 1160
Bulgaria
Burgas, Bulgaria, 8018
Pazardjik, Bulgaria, 4400
Ruse, Bulgaria, 7002
Sofia, Bulgaria, 1309
Sofia, Bulgaria, 1431
Sofia, Bulgaria, 1233
Varna, Bulgaria, 9010
Canada, Alberta
Calgary, Alberta, Canada, T2N 4Z6
Canada, British Columbia
Vancouver, British Columbia, Canada, V5Z 1M9
Victoria, British Columbia, Canada, V8R 4R2
Canada, Ontario
Cambridge, Ontario, Canada, N1R 6V6
Hamilton, Ontario, Canada, L8L 2X2
Ottawa, Ontario, Canada, K1Y 4W7
Toronto, Ontario, Canada, M5B 1W8
Canada, Quebec
Montreal, Quebec, Canada, H2W 1T8
Montreal, Quebec, Canada, H1T 1C8
Montreal, Quebec, Canada, H3T 1E2
Saint-Jean-sur-Richelieu, Quebec, Canada, J3A 1C3
Sherbrooke, Quebec, Canada, J1H 5N4
St-Charles-Borromee, Quebec, Canada, J6E 6J2
Canada
Quebec, Canada, G1V 4G5
Czech Republic
Brno, Czech Republic, 63600
Jindrichuv Hradec, Czech Republic, 377 01
Liberec, Czech Republic, 46063
Ostrava, Czech Republic, 728 80
Plzen - Bory, Czech Republic, 305 99
Praha 5, Czech Republic, 150 30
Slany, Czech Republic, 274 01
Valasske Mezirici, Czech Republic, 757 42
Denmark
Copenhagen Ø, Denmark, 2100
Esbjerg, Denmark, 6700
Glostrup, Denmark, 2600
Hellerup, Denmark, 2900
Herlev, Denmark, 2730
Hvidovre, Denmark, 2650
København NV, Denmark, 2400
Køge, Denmark, 4600
Odense, Denmark, 5000
Svendborg, Denmark, 5700
Viborg, Denmark, 8800
Finland
Espoo, Finland, 02740
Helsinki, Finland, 00099
Jyväskylä, Finland, 40620
Rovaniemi, Finland, 96101
Turku, Finland, 20520
France
Bron, France, 69677
Creteil, France, 94000
Nice, France, 06200
PARIS cedex 10, France, 75475
Paris cedex 13, France, 75013
Rouen, France, 76031
Toulouse, France, 31403
Vandoeuvre les Nancy, France, 54500
Germany
Würzburg, Bayern, Germany, 97078
Frankfurt, Hessen, Germany, 60389
Limburg, Hessen, Germany, 65549
Göttingen, Niedersachsen, Germany, 37099
Hannover, Niedersachsen, Germany, 30625
Stade, Niedersachsen, Germany, 21682
Bad Oeynhausen, Nordrhein-Westfalen, Germany, 32545
Bochum, Nordrhein-Westfalen, Germany, 44789
Mönchengladbach, Nordrhein-Westfalen, Germany, 41063
Mainz, Rheinland-Pfalz, Germany, 55131
Homburg, Saarland, Germany, 66421
Erfurt, Thüringen, Germany, 99089
Berlin, Germany, 13353
Greece
Athens, Attica, Greece, 11527
Haidari, Attica, Greece, 12462
Larissa, Greece, 41111
Nea Ionia / Athens, Greece, 14233
Hungary
Budapest, Hungary, 1027
Budapest, Hungary, H-1096
Budapest, Hungary, 1089
Nagykanizsa, Hungary, 8800
Szekesfehervar, Hungary, 8000
Israel
Afula, Israel, 1834111
Ashkelon, Israel, 7830604
Hadera, Israel, 3810101
Haifa, Israel, 34362
Jerusalem, Israel, 9372212
Kfar Saba, Israel, 4428164
Nahariya, Israel, 22100
Petach Tikva, Israel, 4941492
Rehovot, Israel, 7610001
Safed, Israel, 1311001
Tel Aviv, Israel, 64239
Zerifin, Israel, 6093000
Italy
Cortona, Arezzo, Italy, 52040
Bergamo, Italy, 24127
Foggia, Italy, 71100
Milano, Italy, 20149
Monza, Italy, 20090
Perugia, Italy, 06156
Pisa, Italy, 56124
Roma, Italy, 00163
Korea, Republic of
Wonju-si, Gang''weondo, Korea, Republic of, 220-701
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 110-744
Seoul, Korea, Republic of, 120-752
Seoul, Korea, Republic of, 138-736
Seoul, Korea, Republic of, 137-701
Lithuania
Kaunas, Lithuania, LT-44320
Kaunas, Lithuania, LT-50009
Kaunas, Lithuania, LT-47144
Klaipeda, Lithuania, 92288
Klaipeda, Lithuania, LT-92288
Vilnius, Lithuania, LT-08661
Netherlands
Amsterdam, Netherlands, 1061 AE
Delft, Netherlands, 2625 AD
Groningen, Netherlands, 9728 NT
Groningen, Netherlands, 9700 RB
Hoogeveen, Netherlands, 7909 AA
Nijmegen, Netherlands, 6525 GA
Rotterdam, Netherlands, 3045 PM
Veldhoven, Netherlands, 5504 DB
Zutphen, Netherlands, 7207 AE
Norway
Bodø, Norway, 8092
Haugesund, Norway, 5504
Stavanger, Norway, 4011
Tromsø, Norway, 9038
Tønsberg, Norway, 3116
Poland
Bialystok, Poland, 15-276
Bydgoszcz, Poland, 85-681
Gdansk, Poland, 80-952
Katowice, Poland, 40-635
Kielce, Poland, 25-736
Krakow, Poland, 31-121
Szczecin, Poland, 70-965
Warszawa, Poland, 04-628
Warszawa, Poland, 02-005
Wroclaw, Poland, 50-981
Portugal
Almada, Portugal, 2801-951
Faro, Portugal, 8000-386
Lisboa, Portugal, 1500-650
Lisboa, Portugal, 1449-005
Lisboa, Portugal, 1649-035
Porto, Portugal, P-4200
South Africa
Petoria, Gauteng, South Africa
Isipingo Rail, Kwazulu-Natal, South Africa, 4110
Merebank, Kwazulu-Natal, South Africa, 4052
Tongaat, Kwazulu-Natal, South Africa, 4400
Cape Town, Western Cape, South Africa, 7500
Kuils River, Western Cape, South Africa, 7580
Pinelands, Western Cape, South Africa, 7405
Somerset West, Western Cape, South Africa, 7130
Worcester, Western Cape, South Africa, 6850
Spain
Olot, Girona, Spain, 17800
Majadahonda, Madrid, Spain, 28222
El Palmar, Murcia, Spain, 30120
Barcelona, Spain, 08035
Barcelona, Spain, 08003
Madrid, Spain, 28041
Valencia, Spain, 46010
Valencia, Spain, 46026
Sweden
Falun, Sweden, 791 82
Göteborg, Sweden, 416 85
Stockholm, Sweden, 141 86
Stockholm, Sweden, 118 83
Stockholm, Sweden, 182 88
Umeå, Sweden, 901 85
Örebro, Sweden, 701 85
Taiwan
New Taipei City, Taiwan, 220
Taipei, Taiwan, 100
Taipei, Taiwan
Taipei, Taiwan, 11217
Taizung, Taiwan, 402
Turkey
Ankara, Turkey, 06100
Ankara, Turkey, 06500
Ankara, Turkey
Antalya, Turkey, 07003
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: September 26, 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
Cardiovascular Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Heart Diseases
Metabolic Diseases
Renal Insufficiency
Urologic Diseases
Ventricular Dysfunction
Eplerenone
Cardiovascular Agents
Diuretics
Diuretics, Potassium Sparing
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Mineralocorticoid Receptor Antagonists
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014