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Phase IIb Safety and Efficacy Study 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 Moderate Chronic Kidney Disease Alone (ARTS-HF Japan)

Primary Purpose

Heart Failure

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
BAY94-8862
Eplerenone
Placebo
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring BAY94-8862, MR antagonist, Heart failure, Japanese patients

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects with worsening chronic heart failure requiring emergency presentation to hospital and treatment with intravenous (IV) diuretics at hospital
  • Subjects with either type 2 DM or moderate CKD

Exclusion Criteria:

  • Acute de-novo heart failure or acute inflammatory heart disease, e.g. acute myocarditis
  • Acute coronary syndrome (ACS) (elevated cardiac troponins which are not caused by an ACS are not an exclusion criterion) in the last 30 days prior to the screening visit
  • Cardiogenic shock
  • Valvular heart disease requiring surgical intervention during the course of the study
  • Subjects with left ventricular assistance device or waiting for heart transplantation
  • Stroke or transient ischemic cerebral attack in the last 3 months prior to the screening visit
  • Addison's disease

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Active Comparator

Experimental

Experimental

Experimental

Arm Label

BAY94-8862 (2.5 mg)

BAY94-8862 (5 mg)

Eplerenone

BAY94-8862 (7.5 mg)

BAY94-8862 (10 mg)

BAY94-8862 (15 mg)

Arm Description

2.5 mg BAY94-8862 tablet and placebo capsule once daily in the morning, with possible up-titration to 5 mg once daily at Visit 6 (Day 30), and sham up-titration at Visit 8 (Day 60), based on the value of blood potassium

5 mg BAY94-8862 tablet and placebo capsule once daily in the morning, with possible up-titration to 10 mg once daily at Visit 6 (Day 30), and sham up-titration at Visit 8 (Day 60), based on the value of blood potassium

25 mg eplerenone every other day, i.e. one 25 mg eplerenone capsule on Day 1, Day 3, Day 5, etc. in the morning, 1 placebo capsule on Day 2, Day 4, Day 6, etc. in the morning, and 1 placebo tablet once daily in the morning, with possible up-titration to 25 mg eplerenone once daily at Visit 6 (Day 30), i.e. one 25 mg eplerenone capsule once daily in the morning and 1 placebo tablet once daily in the morning, and a possible up-titration to 25 mg once daily [if not performed at Visit 6 (Day 30)] or to 50 mg once daily [if up-titrated to 25 mg once daily at Visit 6 (Day 30)] at Visit 8 (Day 60), based on the value of blood potassium

7.5 mg BAY94-8862 tablet and placebo capsule once daily in the morning, with possible up-titration to 15 mg once daily at Visit 6 (Day 30), and sham up-titration at Visit 8 (Day 60), based on the value of blood potassium Note: This treatment group may be introduced into the study or not after safety and tolerability of these doses has been assessed by an independent Data Monitoring Committee (DMC) (1st dose recommendation DMC meeting).

10 mg BAY94-8862 tablet and placebo capsule once daily in the morning, with possible up-titration to 20 mg once daily at Visit 6 (Day 30), and sham up-titration at Visit 8 (Day 60), based on the value of blood potassium Note: Only in case the above mentioned additional treatment arm (BAY94-8862, 7.5 mg) has been added, a second dose decision meeting of the DMC will take place, Again safety and tolerability of all doses will be assessed by an independent DMC (2nd dose recommendation DMC meeting). Based on this data, none or up to two treatment groups (BAY94-8862, 10 mg and BAY94-8862,15 mg) may be introduced into the study.

15 mg BAY94-8862 tablet and placebo capsule once daily in the morning, with possible up-titration to 20 mg once daily at Visit 6 (Day 30), and sham up-titration at Visit 8 (Day 60), based on the value of blood potassium Note: Only in case the above mentioned additional treatment arm (BAY94-8862, 7.5 mg) has been added, a second dose decision meeting of the DMC will take place, Again safety and tolerability of all doses will be assessed by an independent DMC (2nd dose recommendation DMC meeting). Based on this data, none or up to two treatment groups (BAY94-8862, 10 mg and BAY94-8862,15 mg) may be introduced into the study.

Outcomes

Primary Outcome Measures

The percentage of subjects with a relative decrease in N-terminal prohormone B-type natriuretic peptide of more than 30% from baseline to Visit 10

Secondary Outcome Measures

Change in serum potassium

Full Information

First Posted
September 30, 2013
Last Updated
July 15, 2021
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT01955694
Brief Title
Phase IIb Safety and Efficacy Study 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 Moderate Chronic Kidney Disease Alone
Acronym
ARTS-HF Japan
Official Title
A Randomized, Double-blind, Double-dummy, Multi-center Study to Assess Safety and Efficacy of BAY94-8862 in Japanese 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 Moderate Chronic Kidney Disease Alone Versus Eplerenone
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
November 11, 2013 (Actual)
Primary Completion Date
January 23, 2015 (Actual)
Study Completion Date
February 20, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will be conducted in subjects with clinical diagnosis of worsening chronic heart failure and either type 2 diabetes mellitus (DM) with or without chronic kidney disease (CKD) or moderate CKD alone treated with evidence-based therapy for heart failure (HF) for at least 3 months prior to emergency presentation to hospital using a multi-center, randomized, adaptive, double-blind, double-dummy, comparator-controlled, parallel-group design. Primary objective of the study is to investigate efficacy [percentage of subjects with a relative decrease in N-terminal prohormone B-type natriuretic peptide (NT-proBNP) of more than 30% from baseline to Visit 10 (Day 90)] and safety of different oral doses of BAY94-8862 given once daily.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
BAY94-8862, MR antagonist, Heart failure, Japanese patients

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BAY94-8862 (2.5 mg)
Arm Type
Experimental
Arm Description
2.5 mg BAY94-8862 tablet and placebo capsule once daily in the morning, with possible up-titration to 5 mg once daily at Visit 6 (Day 30), and sham up-titration at Visit 8 (Day 60), based on the value of blood potassium
Arm Title
BAY94-8862 (5 mg)
Arm Type
Experimental
Arm Description
5 mg BAY94-8862 tablet and placebo capsule once daily in the morning, with possible up-titration to 10 mg once daily at Visit 6 (Day 30), and sham up-titration at Visit 8 (Day 60), based on the value of blood potassium
Arm Title
Eplerenone
Arm Type
Active Comparator
Arm Description
25 mg eplerenone every other day, i.e. one 25 mg eplerenone capsule on Day 1, Day 3, Day 5, etc. in the morning, 1 placebo capsule on Day 2, Day 4, Day 6, etc. in the morning, and 1 placebo tablet once daily in the morning, with possible up-titration to 25 mg eplerenone once daily at Visit 6 (Day 30), i.e. one 25 mg eplerenone capsule once daily in the morning and 1 placebo tablet once daily in the morning, and a possible up-titration to 25 mg once daily [if not performed at Visit 6 (Day 30)] or to 50 mg once daily [if up-titrated to 25 mg once daily at Visit 6 (Day 30)] at Visit 8 (Day 60), based on the value of blood potassium
Arm Title
BAY94-8862 (7.5 mg)
Arm Type
Experimental
Arm Description
7.5 mg BAY94-8862 tablet and placebo capsule once daily in the morning, with possible up-titration to 15 mg once daily at Visit 6 (Day 30), and sham up-titration at Visit 8 (Day 60), based on the value of blood potassium Note: This treatment group may be introduced into the study or not after safety and tolerability of these doses has been assessed by an independent Data Monitoring Committee (DMC) (1st dose recommendation DMC meeting).
Arm Title
BAY94-8862 (10 mg)
Arm Type
Experimental
Arm Description
10 mg BAY94-8862 tablet and placebo capsule once daily in the morning, with possible up-titration to 20 mg once daily at Visit 6 (Day 30), and sham up-titration at Visit 8 (Day 60), based on the value of blood potassium Note: Only in case the above mentioned additional treatment arm (BAY94-8862, 7.5 mg) has been added, a second dose decision meeting of the DMC will take place, Again safety and tolerability of all doses will be assessed by an independent DMC (2nd dose recommendation DMC meeting). Based on this data, none or up to two treatment groups (BAY94-8862, 10 mg and BAY94-8862,15 mg) may be introduced into the study.
Arm Title
BAY94-8862 (15 mg)
Arm Type
Experimental
Arm Description
15 mg BAY94-8862 tablet and placebo capsule once daily in the morning, with possible up-titration to 20 mg once daily at Visit 6 (Day 30), and sham up-titration at Visit 8 (Day 60), based on the value of blood potassium Note: Only in case the above mentioned additional treatment arm (BAY94-8862, 7.5 mg) has been added, a second dose decision meeting of the DMC will take place, Again safety and tolerability of all doses will be assessed by an independent DMC (2nd dose recommendation DMC meeting). Based on this data, none or up to two treatment groups (BAY94-8862, 10 mg and BAY94-8862,15 mg) may be introduced into the study.
Intervention Type
Drug
Intervention Name(s)
BAY94-8862
Intervention Description
2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, and 20 mg of BAY94-8862 tablets
Intervention Type
Drug
Intervention Name(s)
Eplerenone
Intervention Description
INSPRA 25 and 50 mg tablets (MAH: Pfizer) will be used for eplerenone 25 and 50 mg tablets
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
matching placebo
Primary Outcome Measure Information:
Title
The percentage of subjects with a relative decrease in N-terminal prohormone B-type natriuretic peptide of more than 30% from baseline to Visit 10
Time Frame
From baseline to 90 days
Secondary Outcome Measure Information:
Title
Change in serum potassium
Time Frame
From baseline to 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects with worsening chronic heart failure requiring emergency presentation to hospital and treatment with intravenous (IV) diuretics at hospital Subjects with either type 2 DM or moderate CKD Exclusion Criteria: Acute de-novo heart failure or acute inflammatory heart disease, e.g. acute myocarditis Acute coronary syndrome (ACS) (elevated cardiac troponins which are not caused by an ACS are not an exclusion criterion) in the last 30 days prior to the screening visit Cardiogenic shock Valvular heart disease requiring surgical intervention during the course of the study Subjects with left ventricular assistance device or waiting for heart transplantation Stroke or transient ischemic cerebral attack in the last 3 months prior to the screening visit Addison's disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Seto
State/Province
Aichi
ZIP/Postal Code
489-8642
Country
Japan
City
Toyota
State/Province
Aichi
ZIP/Postal Code
471-8513
Country
Japan
City
Funabashi
State/Province
Chiba
ZIP/Postal Code
273-8588
Country
Japan
City
Kamogawa
State/Province
Chiba
ZIP/Postal Code
296-8602
Country
Japan
City
Matsuyama
State/Province
Ehime
ZIP/Postal Code
790-0067
Country
Japan
City
Chikushino
State/Province
Fukuoka
ZIP/Postal Code
818-8516
Country
Japan
City
Amagasaki
State/Province
Hyogo
ZIP/Postal Code
660-8550
Country
Japan
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
650-0047
Country
Japan
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
654-0155
Country
Japan
City
Higashiibaraki
State/Province
Ibaraki
ZIP/Postal Code
311-3193
Country
Japan
City
Hiratsuka
State/Province
Kanagawa
ZIP/Postal Code
254-8502
Country
Japan
City
Kawasaki
State/Province
Kanagawa
ZIP/Postal Code
211-8533
Country
Japan
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
245-8575
Country
Japan
City
Uji
State/Province
Kyoto
ZIP/Postal Code
611-0041
Country
Japan
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
983-8520
Country
Japan
City
Naha
State/Province
Okinawa
ZIP/Postal Code
900-0005
Country
Japan
City
Naha
State/Province
Okinawa
ZIP/Postal Code
902-8511
Country
Japan
City
Urasoe
State/Province
Okinawa
ZIP/Postal Code
901-2132
Country
Japan
City
Sayama
State/Province
Saitama
ZIP/Postal Code
350-1305
Country
Japan
City
Kusatsu
State/Province
Shiga
ZIP/Postal Code
525-8585
Country
Japan
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
162-8655
Country
Japan
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
162-8666
Country
Japan
City
Kofu
State/Province
Yamanashi
ZIP/Postal Code
400-8506
Country
Japan
City
Fukuoka
ZIP/Postal Code
810-0001
Country
Japan
City
Kagoshima
ZIP/Postal Code
892-0853
Country
Japan
City
Kyoto
ZIP/Postal Code
607-8062
Country
Japan
City
Okayama
ZIP/Postal Code
700-8607
Country
Japan
City
Osaka
ZIP/Postal Code
558-8558
Country
Japan
City
Shizuoka
ZIP/Postal Code
420-8630
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
27074824
Citation
Sato N, Ajioka M, Yamada T, Kato M, Myoishi M, Yamada T, Kim SY, Nowack C, Kolkhof P, Shiga T; ARTS-HF Japan study group. A Randomized Controlled Study of Finerenone vs. Eplerenone in Japanese Patients With Worsening Chronic Heart Failure and Diabetes and/or Chronic Kidney Disease. Circ J. 2016 Apr 25;80(5):1113-22. doi: 10.1253/circj.CJ-16-0122. Epub 2016 Apr 14.
Results Reference
result
Links:
URL
http://clinicaltrials.bayer.com/
Description
Click here to find results for studies related to Bayer Healthcare products.

Learn more about this trial

Phase IIb Safety and Efficacy Study 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 Moderate Chronic Kidney Disease Alone

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