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)

July 15, 2021 updated by: Bayer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Fukuoka, Japan, 810-0001
      • Kagoshima, Japan, 892-0853
      • Kyoto, Japan, 607-8062
      • Okayama, Japan, 700-8607
      • Osaka, Japan, 558-8558
      • Shizuoka, Japan, 420-8630
    • Aichi
      • Seto, Aichi, Japan, 489-8642
      • Toyota, Aichi, Japan, 471-8513
    • Chiba
      • Funabashi, Chiba, Japan, 273-8588
      • Kamogawa, Chiba, Japan, 296-8602
    • Ehime
      • Matsuyama, Ehime, Japan, 790-0067
    • Fukuoka
      • Chikushino, Fukuoka, Japan, 818-8516
    • Hyogo
      • Amagasaki, Hyogo, Japan, 660-8550
      • Kobe, Hyogo, Japan, 650-0047
      • Kobe, Hyogo, Japan, 654-0155
    • Ibaraki
      • Higashiibaraki, Ibaraki, Japan, 311-3193
    • Kanagawa
      • Hiratsuka, Kanagawa, Japan, 254-8502
      • Kawasaki, Kanagawa, Japan, 211-8533
      • Yokohama, Kanagawa, Japan, 245-8575
    • Kyoto
      • Uji, Kyoto, Japan, 611-0041
    • Miyagi
      • Sendai, Miyagi, Japan, 983-8520
    • Okinawa
      • Naha, Okinawa, Japan, 902-8511
      • Naha, Okinawa, Japan, 900-0005
      • Urasoe, Okinawa, Japan, 901-2132
    • Saitama
      • Sayama, Saitama, Japan, 350-1305
    • Shiga
      • Kusatsu, Shiga, Japan, 525-8585
    • Tokyo
      • Shinjuku-ku, Tokyo, Japan, 162-8655
      • Shinjuku-ku, Tokyo, Japan, 162-8666
    • Yamanashi
      • Kofu, Yamanashi, Japan, 400-8506

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: BAY94-8862 (2.5 mg)
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
Drug: Placebo
matching placebo
Drug: BAY94-8862
2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, and 20 mg of BAY94-8862 tablets
EXPERIMENTAL: BAY94-8862 (5 mg)
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
Drug: Placebo
matching placebo
Drug: BAY94-8862
2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, and 20 mg of BAY94-8862 tablets
ACTIVE_COMPARATOR: Eplerenone
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
Drug: Placebo
matching placebo
Drug: Eplerenone
INSPRA 25 and 50 mg tablets (MAH: Pfizer) will be used for eplerenone 25 and 50 mg tablets
EXPERIMENTAL: BAY94-8862 (7.5 mg)
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).
Drug: Placebo
matching placebo
Drug: BAY94-8862
2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, and 20 mg of BAY94-8862 tablets
EXPERIMENTAL: BAY94-8862 (10 mg)
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.
Drug: Placebo
matching placebo
Drug: BAY94-8862
2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, and 20 mg of BAY94-8862 tablets
EXPERIMENTAL: BAY94-8862 (15 mg)
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.
Drug: Placebo
matching placebo
Drug: BAY94-8862
2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, and 20 mg of BAY94-8862 tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
From baseline to 90 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in serum potassium
Time Frame: From baseline to 90 days
From baseline to 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 11, 2013

Primary Completion (ACTUAL)

January 23, 2015

Study Completion (ACTUAL)

February 20, 2015

Study Registration Dates

First Submitted

September 30, 2013

First Submitted That Met QC Criteria

September 30, 2013

First Posted (ESTIMATE)

October 7, 2013

Study Record Updates

Last Update Posted (ACTUAL)

July 16, 2021

Last Update Submitted That Met QC Criteria

July 15, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16815

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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