Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01807221




Registration number
NCT01807221
Ethics application status
Date submitted
7/03/2013
Date registered
8/03/2013
Date last updated
6/07/2021

Titles & IDs
Public title
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
Scientific 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
Secondary ID [1] 0 0
2012-002627-15
Secondary ID [2] 0 0
14564
Universal Trial Number (UTN)
Trial acronym
ARTS-HF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.

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.

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.

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.

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.

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.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With a Relative Decrease in NT-proBNP of More Than 30% From Baseline to Day 90
Timepoint [1] 0 0
Baseline and Day 90
Secondary outcome [1] 0 0
Number of Participants With Death Due to Any Cause
Timepoint [1] 0 0
Day 30, Day 60, Day 90 and Follow-up (30 days post-last dose, assessed up to Day 120)
Secondary outcome [2] 0 0
Number of Participants With Cardiovascular Hospitalization
Timepoint [2] 0 0
Day 30, Day 60, Day 90 and Follow-up (30 days post-last dose, assessed up to Day 120)
Secondary outcome [3] 0 0
Number of Participants With Emergency Presentations for Worsening Chronic Heart Failure (WCHF)
Timepoint [3] 0 0
Day 30, Day 60, Day 90 and Follow-up (30 days post-last dose, assessed up to Day 120)
Secondary outcome [4] 0 0
Ratio of BNP at Specified Visits to BNP at Baseline
Timepoint [4] 0 0
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)
Secondary outcome [5] 0 0
Ratio of NT-proBNP at Specified Visits to NT-proBNP at Baseline
Timepoint [5] 0 0
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)
Secondary outcome [6] 0 0
Change From Baseline in KCCQ Questionnaire Scores at Specified Visits
Timepoint [6] 0 0
Baseline, Day 30 and Day 90
Secondary outcome [7] 0 0
Change From Baseline in EQ-5D-3L Questionnaire Scores at Specified Visits
Timepoint [7] 0 0
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)

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/06/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
9/12/2014
Sample size
Target
Accrual to date
Final
1066
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 0 0
- Darlinghurst
Recruitment hospital [2] 0 0
- Adelaide
Recruitment hospital [3] 0 0
- Concord
Recruitment hospital [4] 0 0
- Prahran
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
5042 - Adelaide
Recruitment postcode(s) [3] 0 0
2139 - Concord
Recruitment postcode(s) [4] 0 0
3004 - Prahran
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
New Jersey
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
Austria
State/province [9] 0 0
Niederösterreich
Country [10] 0 0
Austria
State/province [10] 0 0
Oberösterreich
Country [11] 0 0
Austria
State/province [11] 0 0
Steiermark
Country [12] 0 0
Austria
State/province [12] 0 0
Tirol
Country [13] 0 0
Austria
State/province [13] 0 0
Salzburg
Country [14] 0 0
Austria
State/province [14] 0 0
Wien
Country [15] 0 0
Bulgaria
State/province [15] 0 0
Burgas
Country [16] 0 0
Bulgaria
State/province [16] 0 0
Pazardzhik
Country [17] 0 0
Bulgaria
State/province [17] 0 0
Ruse
Country [18] 0 0
Bulgaria
State/province [18] 0 0
Sofia
Country [19] 0 0
Bulgaria
State/province [19] 0 0
Varna
Country [20] 0 0
Canada
State/province [20] 0 0
Alberta
Country [21] 0 0
Canada
State/province [21] 0 0
Ontario
Country [22] 0 0
Canada
State/province [22] 0 0
Quebec
Country [23] 0 0
Czechia
State/province [23] 0 0
Jindrichuv Hradec
Country [24] 0 0
Czechia
State/province [24] 0 0
Ostrava
Country [25] 0 0
Czechia
State/province [25] 0 0
Praha 5
Country [26] 0 0
Czechia
State/province [26] 0 0
Slany
Country [27] 0 0
Denmark
State/province [27] 0 0
Copenhagen Ø
Country [28] 0 0
Denmark
State/province [28] 0 0
Esbjerg
Country [29] 0 0
Denmark
State/province [29] 0 0
Glostrup
Country [30] 0 0
Denmark
State/province [30] 0 0
Hellerup
Country [31] 0 0
Denmark
State/province [31] 0 0
Herlev
Country [32] 0 0
Denmark
State/province [32] 0 0
Hvidovre
Country [33] 0 0
Denmark
State/province [33] 0 0
København NV
Country [34] 0 0
Denmark
State/province [34] 0 0
Køge
Country [35] 0 0
Denmark
State/province [35] 0 0
Svendborg
Country [36] 0 0
Denmark
State/province [36] 0 0
Viborg
Country [37] 0 0
Finland
State/province [37] 0 0
Espoo
Country [38] 0 0
Finland
State/province [38] 0 0
Helsinki
Country [39] 0 0
Finland
State/province [39] 0 0
Rovaniemi
Country [40] 0 0
Finland
State/province [40] 0 0
Turku
Country [41] 0 0
France
State/province [41] 0 0
Bron
Country [42] 0 0
France
State/province [42] 0 0
Nice
Country [43] 0 0
France
State/province [43] 0 0
PARIS cedex 10
Country [44] 0 0
France
State/province [44] 0 0
Paris cedex 13
Country [45] 0 0
France
State/province [45] 0 0
Rouen
Country [46] 0 0
France
State/province [46] 0 0
Toulouse
Country [47] 0 0
France
State/province [47] 0 0
Vandoeuvre les Nancy
Country [48] 0 0
Germany
State/province [48] 0 0
Bayern
Country [49] 0 0
Germany
State/province [49] 0 0
Hessen
Country [50] 0 0
Germany
State/province [50] 0 0
Niedersachsen
Country [51] 0 0
Germany
State/province [51] 0 0
Nordrhein-Westfalen
Country [52] 0 0
Germany
State/province [52] 0 0
Saarland
Country [53] 0 0
Germany
State/province [53] 0 0
Thüringen
Country [54] 0 0
Germany
State/province [54] 0 0
Berlin
Country [55] 0 0
Greece
State/province [55] 0 0
Athens
Country [56] 0 0
Greece
State/province [56] 0 0
Chaidari
Country [57] 0 0
Greece
State/province [57] 0 0
Larissa
Country [58] 0 0
Greece
State/province [58] 0 0
Nea Ionia / Athens
Country [59] 0 0
Hungary
State/province [59] 0 0
Budapest
Country [60] 0 0
Hungary
State/province [60] 0 0
Nagykanizsa
Country [61] 0 0
Hungary
State/province [61] 0 0
Szekesfehervar
Country [62] 0 0
Israel
State/province [62] 0 0
Afula
Country [63] 0 0
Israel
State/province [63] 0 0
Ashkelon
Country [64] 0 0
Israel
State/province [64] 0 0
Hadera
Country [65] 0 0
Israel
State/province [65] 0 0
Haifa
Country [66] 0 0
Israel
State/province [66] 0 0
Jerusalem
Country [67] 0 0
Israel
State/province [67] 0 0
Kfar Saba
Country [68] 0 0
Israel
State/province [68] 0 0
Nahariya
Country [69] 0 0
Israel
State/province [69] 0 0
Petach Tikva
Country [70] 0 0
Israel
State/province [70] 0 0
Rehovot
Country [71] 0 0
Israel
State/province [71] 0 0
Tel Aviv
Country [72] 0 0
Israel
State/province [72] 0 0
Zefat
Country [73] 0 0
Israel
State/province [73] 0 0
Zerifin
Country [74] 0 0
Italy
State/province [74] 0 0
Lazio
Country [75] 0 0
Italy
State/province [75] 0 0
Lombardia
Country [76] 0 0
Italy
State/province [76] 0 0
Puglia
Country [77] 0 0
Italy
State/province [77] 0 0
Toscana
Country [78] 0 0
Italy
State/province [78] 0 0
Umbria
Country [79] 0 0
Korea, Republic of
State/province [79] 0 0
Gang''weondo
Country [80] 0 0
Korea, Republic of
State/province [80] 0 0
Seoul
Country [81] 0 0
Lithuania
State/province [81] 0 0
Kaunas
Country [82] 0 0
Lithuania
State/province [82] 0 0
Klaipeda
Country [83] 0 0
Lithuania
State/province [83] 0 0
Vilnius
Country [84] 0 0
Netherlands
State/province [84] 0 0
Amsterdam
Country [85] 0 0
Netherlands
State/province [85] 0 0
Delft
Country [86] 0 0
Netherlands
State/province [86] 0 0
Groningen
Country [87] 0 0
Netherlands
State/province [87] 0 0
Hoogeveen
Country [88] 0 0
Netherlands
State/province [88] 0 0
Nijmegen
Country [89] 0 0
Netherlands
State/province [89] 0 0
Rotterdam
Country [90] 0 0
Netherlands
State/province [90] 0 0
Veldhoven
Country [91] 0 0
Netherlands
State/province [91] 0 0
Zutphen
Country [92] 0 0
Norway
State/province [92] 0 0
Stavanger
Country [93] 0 0
Poland
State/province [93] 0 0
Bialystok
Country [94] 0 0
Poland
State/province [94] 0 0
Bydgoszcz
Country [95] 0 0
Poland
State/province [95] 0 0
Gdansk
Country [96] 0 0
Poland
State/province [96] 0 0
Katowice
Country [97] 0 0
Poland
State/province [97] 0 0
Kielce
Country [98] 0 0
Poland
State/province [98] 0 0
Krakow
Country [99] 0 0
Poland
State/province [99] 0 0
Szczecin
Country [100] 0 0
Poland
State/province [100] 0 0
Warszawa
Country [101] 0 0
Poland
State/province [101] 0 0
Wroclaw
Country [102] 0 0
Portugal
State/province [102] 0 0
Almada
Country [103] 0 0
Portugal
State/province [103] 0 0
Faro
Country [104] 0 0
Portugal
State/province [104] 0 0
Lisboa
Country [105] 0 0
Portugal
State/province [105] 0 0
Porto
Country [106] 0 0
South Africa
State/province [106] 0 0
Gauteng
Country [107] 0 0
South Africa
State/province [107] 0 0
Kwazulu-Natal
Country [108] 0 0
South Africa
State/province [108] 0 0
Western Cape
Country [109] 0 0
Spain
State/province [109] 0 0
Girona
Country [110] 0 0
Spain
State/province [110] 0 0
Madrid
Country [111] 0 0
Spain
State/province [111] 0 0
Murcia
Country [112] 0 0
Spain
State/province [112] 0 0
Barcelona
Country [113] 0 0
Spain
State/province [113] 0 0
Valencia
Country [114] 0 0
Sweden
State/province [114] 0 0
Falun
Country [115] 0 0
Sweden
State/province [115] 0 0
Göteborg
Country [116] 0 0
Sweden
State/province [116] 0 0
Stockholm
Country [117] 0 0
Sweden
State/province [117] 0 0
Umeå
Country [118] 0 0
Sweden
State/province [118] 0 0
Örebro
Country [119] 0 0
Taiwan
State/province [119] 0 0
New Taipei City
Country [120] 0 0
Taiwan
State/province [120] 0 0
Taipei
Country [121] 0 0
Taiwan
State/province [121] 0 0
Taizung
Country [122] 0 0
Turkey
State/province [122] 0 0
Ankara
Country [123] 0 0
Turkey
State/province [123] 0 0
Antalya
Country [124] 0 0
Turkey
State/province [124] 0 0
Izmir

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bayer
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT01807221
Trial related presentations / 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.
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Bayer Study Director
Address 0 0
Bayer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01807221