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)
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ClinicalTrials.gov Identifier: NCT01807221 |
Recruitment Status
:
Completed
First Posted
: March 8, 2013
Last Update Posted
: October 17, 2016
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Heart Failure | Drug: Finerenone (BAY94-8862) Drug: Placebo Drug: Inspra (eplerenone) | Phase 2 |
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 |

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) |
- Relative decrease in N-terminal prohormone B-type natriuretic peptide (NT-proBNP) [ Time Frame: From baseline to 90 days ]
- Change in serum potassium [ Time Frame: From baseline to 90 days ]
- Change in blood pressure [ Time Frame: From baseline to 90 days ]
- Change in heart rate [ Time Frame: From baseline to 90 days ]
- Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: Up to 120 days ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01807221

Study Director: | Bayer Study Director | Bayer |
Additional Information:
Publications of Results:
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 Key Record Dates |
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 |