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

Heart Failure Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01955694
• Other study ID #: 16815
• Status: Completed
• Phase: Phase 2
• Start date: November 11, 2013
• Est. completion date: February 20, 2015

Study information

• Verified date: July 2021
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: February 20, 2015
• Est. primary completion date: January 23, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Heart Failure
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• BAY94-8862
2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, and 20 mg of BAY94-8862 tablets
• Eplerenone
INSPRA 25 and 50 mg tablets (MAH: Pfizer) will be used for eplerenone 25 and 50 mg tablets
• Placebo
matching placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Japan, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		From baseline to 90 days
Secondary	Change in serum potassium		From baseline to 90 days

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