Status:
COMPLETED
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 Chronic Kidney Disease Alone
Lead Sponsor:
Bayer
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 diabe...
Eligibility Criteria
Inclusion
- 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 \</= eGFR \</= 60 mL/min/1.73m\^2 (MDRD, Modification of Diet in Renal Disease Study Group) at screening
- Left ventricular ejection fraction (LVEF) \</= 40%
- Blood potassium \</= 5.0 mmol/L at screening
- Systolic blood pressure \>/= 90 mmHg without signs and symptoms of hypotension at the screening visit
Exclusion
- 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
Key Trial Info
Start Date :
June 17 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 9 2014
Estimated Enrollment :
1066 Patients enrolled
Trial Details
Trial ID
NCT01807221
Start Date
June 17 2013
End Date
December 9 2014
Last Update
July 6 2021
Active Locations (172)
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1
Birmingham, Alabama, United States, 35294-2041
2
La Jolla, California, United States, 92037
3
Los Angeles, California, United States, 90033
4
Jacksonville, Florida, United States, 32209