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 - Full Text View

Purpose

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	Intervention	Phase
Heart Failure	Drug: Finerenone (BAY94-8862) Drug: Placebo Drug: Inspra (eplerenone)	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (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

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure Kidney Diseases

Drug Information available for: Eplerenone

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]


Enrollment:	1058
Study Start Date:	June 2013
Study Completion Date:	December 2014
Primary Completion Date:	November 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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)

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01807221

Show 203 Study Locations

Sponsors and Collaborators

Bayer

Investigators


Study Director:	Bayer Study Director	Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA. This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product. This link exits the ClinicalTrials.gov site

Publications:

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 )
Study First Received:	March 7, 2013
Last Updated:	October 14, 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

ClinicalTrials.gov processed this record on August 16, 2017

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)