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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Treatment: Drugs - Finerenone (BAY94-8862)
Treatment: Drugs - Placebo
Treatment: Drugs - Inspra (eplerenone)

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.


Treatment: Drugs: Finerenone (BAY94-8862)


Treatment: Drugs: Placebo


Treatment: Drugs: Inspra (eplerenone)
Intervention code [1] 0 0
Treatment: Drugs
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
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United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
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United States of America
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Georgia
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United States of America
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Maryland
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United States of America
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Michigan
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United States of America
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New Jersey
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United States of America
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Ohio
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Austria
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Niederösterreich
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Austria
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Oberösterreich
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Austria
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Steiermark
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Austria
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Tirol
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Austria
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Salzburg
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Austria
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Wien
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Bulgaria
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Burgas
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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
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Bulgaria
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Varna
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Canada
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Alberta
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Ontario
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Jindrichuv Hradec
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Esbjerg
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Glostrup
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Hellerup
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Hvidovre
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København NV
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Svendborg
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Viborg
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Finland
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Espoo
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Finland
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Helsinki
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Rovaniemi
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Bron
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Paris cedex 13
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Toulouse
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Vandoeuvre les Nancy
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Bayern
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Porto
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Gauteng
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South Africa
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Kwazulu-Natal
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South Africa
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Western Cape
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Spain
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Girona
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Madrid
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Murcia
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Barcelona
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Valencia
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Falun
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Göteborg
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Stockholm
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Umeå
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Örebro
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New Taipei City
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Taizung
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Ankara
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Antalya
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Turkey
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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/ct2/show/NCT01807221
Trial related presentations / publications
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/ct2/show/NCT01807221