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)

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
Heart Failure	Drug: Finerenone (BAY94-8862); Drug: Placebo; Drug: Inspra (eplerenone)	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	1058 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, 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
Study Start Date :	June 2013
Actual Primary Completion Date :	November 2014
Actual Study Completion Date :	December 2014

Arms and Interventions

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Arm	Intervention/treatment
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)

Outcome Measures

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Primary Outcome Measures :

1. Relative decrease in N-terminal prohormone B-type natriuretic peptide (NT-proBNP) [ Time Frame: From baseline to 90 days ]

Secondary Outcome Measures :

1. Change in serum potassium [ Time Frame: From baseline to 90 days ]
2. Change in blood pressure [ Time Frame: From baseline to 90 days ]
3. Change in heart rate [ Time Frame: From baseline to 90 days ]
4. Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: Up to 120 days ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
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

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  Show 203 Study Locations

Sponsors and Collaborators

Bayer

Investigators

Study Director:	Bayer Study Director	Bayer

More Information

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Additional Information:

Click here and search for drug information provided by the FDA. 

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Publications of Results:

Filippatos G, Anker SD, Böhm M, Gheorghiade M, Køber 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.

Responsible Party:	Bayer
ClinicalTrials.gov Identifier:	NCT01807221 History of Changes
Other Study ID Numbers:	14564; 2012-002627-15 ( EudraCT Number )
First Posted:	March 8, 2013
Last Update Posted:	October 17, 2016
Last Verified:	October 2016

Keywords provided by Bayer:

Heart Decompensation

Additional relevant MeSH terms:

Diabetes Mellitus; Heart Failure; Diabetes Mellitus, Type 2; 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; Spironolactone; Mineralocorticoid Receptor Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Diuretics, Potassium Sparing; Diuretics; Natriuretic Agents