Overview

Phase IIb Safety and Efficacy Study of Different Oral Doses 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 Chroni

Status:
Completed
Trial end date:
2014-12-09
Target enrollment:
0
Participant gender:
All
Summary
To assess a new drug, BAY94-8862, given orally at different doses, to evaluate whether it was safe and can help the well-being of patients with worsening chronic heart failure and either type II diabetes with or without chronic kidney disease or kidney disease alone. These treatment doses were compared to eplerenone, another marketed drug approved to treat heart failure.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bayer
Treatments:
Eplerenone
Spironolactone
Criteria
Inclusion Criteria:

- Men and women aged 18 years and older. The lower age limit may be higher if legally
required in the participating country

- Women of childbearing potential can only be included in the study if a pregnancy test
is negative and if they agree to use adequate contraception when sexually active

- Subjects with worsening chronic heart failure requiring emergency presentation to
hospital and treatment with intravenous diuretics at hospital

- Subjects with clinical diagnosis of chronic heart failure (CHF) either ischemic or non
ischemic, New York Heart Association (NYHA) functional class II-IV

- Subjects with type 2 diabetes mellitus and / or

- Subjects with 30 mL/min/1.73m^2 Diet in Renal Disease Study Group) at screening

- Left ventricular ejection fraction (LVEF)
- Blood potassium
- Systolic blood pressure >/= 90 mmHg without signs and symptoms of hypotension at the
screening visit

Exclusion Criteria:

- Acute de-novo heart failure or acute inflammatory heart disease, e.g. acute
myocarditis

- Acute coronary syndrome (ACS) in last 30 days prior to screening

- Cardiogenic shock

- Valvular heart disease requiring surgical intervention during the course of the study

- Stroke or transient ischemic cerebral attack in the last 3 months prior to the
screening visit

- Concomitant treatment with any mineralocorticoid receptor antagonist (MRA), renin
inhibitor, or potassium-sparing diuretic