Clinical trial NCT01955694: 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
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Heart Failure
Keywords: BAY94-8862
MR antagonist
Heart failure
Japanese patients
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2013-10-07
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
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
timeFrame: From baseline to 90 days
Secondary outcomes:
measure: Change in serum potassium
timeFrame: From baseline to 90 days
Other outcomes:
Locations:
city: Seto
country: Japan
state: Aichi
city: Toyota
country: Japan
state: Aichi
city: Funabashi
country: Japan
state: Chiba
city: Kamogawa
country: Japan
state: Chiba
city: Matsuyama
country: Japan
state: Ehime
city: Chikushino
country: Japan
state: Fukuoka
city: Amagasaki
country: Japan
state: Hyogo
city: Kobe
country: Japan
state: Hyogo
city: Kobe
country: Japan
state: Hyogo
city: Higashiibaraki
country: Japan
state: Ibaraki
city: Hiratsuka
country: Japan
state: Kanagawa
city: Kawasaki
country: Japan
state: Kanagawa
city: Yokohama
country: Japan
state: Kanagawa
city: Uji
country: Japan
state: Kyoto
city: Sendai
country: Japan
state: Miyagi
city: Naha
country: Japan
state: Okinawa
city: Naha
country: Japan
state: Okinawa
city: Urasoe
country: Japan
state: Okinawa
city: Sayama
country: Japan
state: Saitama
city: Kusatsu
country: Japan
state: Shiga
city: Shinjuku-ku
country: Japan
state: Tokyo
city: Shinjuku-ku
country: Japan
state: Tokyo
city: Kofu
country: Japan
state: Yamanashi
city: Fukuoka
country: Japan
city: Kagoshima
country: Japan
city: Kyoto
country: Japan
city: Okayama
country: Japan
city: Osaka
country: Japan
city: Shizuoka
country: Japan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
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.