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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
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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
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Secondary ID [1]
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2012-002627-15
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Secondary ID [2]
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14564
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Universal Trial Number (UTN)
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Trial acronym
ARTS-HF
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Heart Failure
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Condition category
Condition code
Renal and Urogenital
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0
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Kidney disease
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Renal and Urogenital
0
0
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0
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Other renal and urogenital disorders
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Cardiovascular
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0
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0
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Coronary heart disease
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Cardiovascular
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0
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Other cardiovascular diseases
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Metabolic and Endocrine
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0
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Diabetes
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Intervention/exposure
Study type
Interventional
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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.
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With a Relative Decrease in NT-proBNP of More Than 30% From Baseline to Day 90
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline and Day 90
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Secondary outcome [1]
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Number of Participants With Death Due to Any Cause
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Assessment method [1]
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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.
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Timepoint [1]
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Day 30, Day 60, Day 90 and Follow-up (30 days post-last dose, assessed up to Day 120)
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Secondary outcome [2]
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Number of Participants With Cardiovascular Hospitalization
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Assessment method [2]
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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.
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Timepoint [2]
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Day 30, Day 60, Day 90 and Follow-up (30 days post-last dose, assessed up to Day 120)
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Secondary outcome [3]
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Number of Participants With Emergency Presentations for Worsening Chronic Heart Failure (WCHF)
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Assessment method [3]
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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.
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Timepoint [3]
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Day 30, Day 60, Day 90 and Follow-up (30 days post-last dose, assessed up to Day 120)
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Secondary outcome [4]
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Ratio of BNP at Specified Visits to BNP at Baseline
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Assessment method [4]
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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.
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Timepoint [4]
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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)
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Secondary outcome [5]
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Ratio of NT-proBNP at Specified Visits to NT-proBNP at Baseline
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Assessment method [5]
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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.
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Timepoint [5]
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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)
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Secondary outcome [6]
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Change From Baseline in KCCQ Questionnaire Scores at Specified Visits
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Assessment method [6]
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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.
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Timepoint [6]
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Baseline, Day 30 and Day 90
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Secondary outcome [7]
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Change From Baseline in EQ-5D-3L Questionnaire Scores at Specified Visits
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Assessment method [7]
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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.
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Timepoint [7]
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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)
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
17/06/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
9/12/2014
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Sample size
Target
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Accrual to date
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Final
1066
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Recruitment in Australia
Recruitment state(s)
NSW,SA
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Recruitment hospital [1]
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- Darlinghurst
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- Adelaide
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- Concord
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Recruitment hospital [4]
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- Prahran
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Recruitment postcode(s) [1]
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2010 - Darlinghurst
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Recruitment postcode(s) [2]
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5042 - Adelaide
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Recruitment postcode(s) [3]
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2139 - Concord
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Recruitment postcode(s) [4]
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3004 - Prahran
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Recruitment outside Australia
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United States of America
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Poland
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Wroclaw
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Portugal
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Almada
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Portugal
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Faro
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Portugal
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Lisboa
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Portugal
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Porto
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South Africa
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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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Spain
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Madrid
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Spain
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Murcia
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Spain
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Barcelona
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Spain
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Valencia
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Sweden
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State/province [114]
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Falun
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Country [115]
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Sweden
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Göteborg
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Sweden
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Stockholm
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Sweden
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Umeå
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Sweden
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Örebro
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Taiwan
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New Taipei City
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Taiwan
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Taipei
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Taiwan
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Taizung
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Turkey
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Ankara
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Turkey
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Antalya
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Turkey
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Izmir
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Bayer
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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.
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Trial website
https://clinicaltrials.gov/study/NCT01807221
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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.
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Public notes
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Contacts
Principal investigator
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Bayer Study Director
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Bayer
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Filippatos G, Anker SD, Bohm M, Gheorghiade M, Kob...
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Journal
Chung EY, Ruospo M, Natale P, Bolignano D, Navanee...
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Journal
Pitt B, Anker SD, Bohm M, Gheorghiade M, Kober L, ...
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Results are available at
https://clinicaltrials.gov/study/NCT01807221
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