Overview

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 Diseas

Status:
Completed
Trial end date:
2015-02-20
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bayer
Treatments:
Eplerenone
Spironolactone
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