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)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Bayer
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01807221
First received: March 7, 2013
Last updated: June 20, 2014
Last verified: June 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:


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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in serum potassium [ Time Frame: From baseline to 90 days ] [ Designated as safety issue: Yes ]
  • Change in blood pressure [ Time Frame: From baseline to 90 days ] [ Designated as safety issue: Yes ]
  • Change in heart rate [ Time Frame: From baseline to 90 days ] [ Designated as safety issue: Yes ]
  • Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: Up to 120 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1060
Study Start Date: June 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: December 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
Genders Eligible for Study:   Both
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

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com
Contact: For trial location information (Phone Menu Options '3' or '4') (+)1-888-84 22937

  Show 202 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01807221     History of Changes
Other Study ID Numbers: 14564, 2012-002627-15
Study First Received: March 7, 2013
Last Updated: June 20, 2014
Health Authority: Austria: Austrian Medicines and Medical Devices Agency
Australia: Department of Health and Ageing Therapeutic Goods Administration
Canada: Health Canada
Czech Republic: State Institute for Drug Control
Denmark: Danish Health and Medicines Authority
Finland: Finnish Medicines Agency
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Germany: Federal Institute for Drugs and Medical Devices
Greece: National Organization of Medicines
Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines
Israel: Ministry of Health
Italy: The Italian Medicines Agency
Lithuania: State Medicine Control Agency - Ministry of Health
Netherlands: Medicines Evaluation Board (MEB)
Norway: Norwegian Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Portugal: INFARMED - National Authority of Medicines and Health Products
South Africa: Medicines Control Council
South Korea: Korea Food and Drug Administration (KFDA)
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Sweden: Medical Products Agency
United States: Food and Drug Administration
Taiwan : Food and Drug Administration

Keywords provided by Bayer:
Heart Decompensation

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Heart Failure
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Ventricular Dysfunction, Left
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases
Urologic Diseases
Renal Insufficiency
Ventricular Dysfunction
Eplerenone
Aldosterone Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014