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Heart FailurePhase 2ARTS-HF JapanNCT01955694

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

A Phase 2 study testing BAY94-8862 and Eplerenone in people with Heart Failure, run by Bayer at 29 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure
What is being tested?
BAY94-8862 and Eplerenone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
72 participants
Where
29 sitesJapan
Study dates
11 Nov 2013to 20 Feb 2015
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

29 sites in 1 country.

29 sites in 1 country

Japan29 sites

  • Study site

    Amagasaki, Hyōgo, 660-8550

  • Study site

    Chikushino-shi, Fukuoka, 818-8516

  • Study site

    Fukuoka, 810-0001

  • Study site

    Funabashi, Chiba, 273-8588

  • Study site

    Higashiibaraki, Ibaraki, 311-3193

  • Study site

    Hiratsuka, Kanagawa, 254-8502

  • Study site

    Kagoshima, 892-0853

  • Study site

    Kamogawa, Chiba, 296-8602

  • Study site

    Kawasaki, Kanagawa, 211-8533

  • Study site

    Kobe, Hyōgo, 650-0047

  • Study site

    Kobe, Hyōgo, 654-0155

  • Study site

    Kofu, Yamanashi, 400-8506

  • Study site

    Kusatsu, Shiga, 525-8585

  • Study site

    Kyoto, 607-8062

  • Study site

    Matsuyama, Ehime, 790-0067

  • Study site

    Naha, Okinawa, 900-0005

  • Study site

    Naha, Okinawa, 902-8511

  • Study site

    Okayama, 700-8607

  • Study site

    Osaka, 558-8558

  • Study site

    Sayama, Saitama, 350-1305

  • Study site

    Sendai, Miyagi, 983-8520

  • Study site

    Seto, Aichi-ken, 489-8642

  • Study site

    Shinjuku-ku, Tokyo, 162-8655

  • Study site

    Shinjuku-ku, Tokyo, 162-8666

  • Study site

    Shizuoka, 420-8630

  • Study site

    Toyota, Aichi-ken, 471-8513

  • Study site

    Uji, Kyoto, 611-0041

  • Study site

    Urasoe, Okinawa, 901-2132

  • Study site

    Yokohama, Kanagawa, 245-8575

Other trials in Japan

About this study

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

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.

Conditions
Heart Failure
Being tested
BAY94-8862, Eplerenone, Placebo
Keywords
BAY94-8862, MR antagonist, Heart failure, Japanese patients
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BAY94-8862Drug

    2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, and 20 mg of BAY94-8862 tablets

  • EplerenoneDrug

    INSPRA 25 and 50 mg tablets (MAH: Pfizer) will be used for eplerenone 25 and 50 mg tablets

  • PlaceboDrug

    matching placebo

Study groups in NCT01955694
Study groupRoleWhat they receive
BAY94-8862 (2.5 mg)Experimental2.5 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
Receives: Drug: BAY94-8862; Drug: Placebo
BAY94-8862 (5 mg)Experimental5 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
Receives: Drug: BAY94-8862; Drug: Placebo
EplerenoneActive comparator25 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
Receives: Drug: Eplerenone; Drug: Placebo
BAY94-8862 (7.5 mg)Experimental7.5 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).
Receives: Drug: BAY94-8862; Drug: Placebo
BAY94-8862 (10 mg)Experimental10 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.
Receives: Drug: BAY94-8862; Drug: Placebo
BAY94-8862 (15 mg)Experimental15 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.
Receives: Drug: BAY94-8862; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: From baseline to 90 days

Secondary outcomes (1)

  1. Change in serum potassium

    Measured: From baseline to 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Oct 2013 (estimated)
  2. Study start11 Nov 2013
  3. Primary completion23 Jan 2015
  4. Study completion20 Feb 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01955694
Sponsor's protocol ID
16815
Acronym
ARTS-HF Japan
Status last verified
Jul 2021
First submitted
30 Sep 2013
Last updated
16 Jul 2021
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 27074824

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BAY94-8862 and Eplerenone in people with Heart Failure, run by Bayer at 29 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01955694, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2021.

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