Heart Failure
Conditions
Keywords
Chronic Heart Failure
Brief summary
A placebo (Part A) and placebo and active comparator controlled (Part B), double-blind and randomized study to assess safety and tolerability of a new drug (BAY94-8862) given orally
Interventions
DRUGBAY94-8862
Two 1.25 mg BAY94-8862 and 2 placebo tablets for duration of 4 weeks
DRUGPlacebo
Placebo tablets for duration of 4 weeks
DRUGSpironolactone
Part B only: 25 mg spironolactone once daily with up-titration to 50 mg once daily starting at day 15, if serum potassium is less or equal to 4.8 mmol/L, for duration of 4 weeks
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men aged 18 years and older or postmenopausal women aged 55 years and older or women aged 18 years and older without childbearing potential based on surgical treatment such as bilateral tubal ligation, bilateral ovarectomy, or hysterectomy * Clinical diagnosis of CHF (chronic heart failure), either ischemic or non-ischemic, NYHA (New York Heart Association) class II - III, treated with evidenced-based therapy for CHF, e.g. beta-blockers and ACE (angiotensin-converting enzyme) inhibitors or ARB (angiotensin receptor blocker) as well as diuretics, unless contraindicated or not tolerated * Known kidney damage for \>/= 3 months, as defined by structural or functional abnormalities of the kidney, and * Part A: 60 mL/min/1.73 m\*2 \</= eGFR (estimated Glomerular Filtration Rate) \< 90 mL/min/1.73 m\*2 (MDRD, Modification of Diet in Renal Disease) at the screening visit * Part B: 30 mL/min/1.73 m\*2 \</= eGFR \<= 60 mL/min/1.73 m\*2 (MDRD) at the screening visit * Serum potassium \</= 4.8 mmol/L at the screening visit * Systolic blood pressure \>/= 90 mmHg without signs or symptoms of hypotension at the screening visit
Exclusion criteria
* Known hypersensitivity to the study drug (active substance or excipients) or spironolactone and respective excipients (Part B only) * Subjects with anuria, acute renal failure, or Addison's disease * Acute coronary syndrome or unstable coronary artery disease within 30 days prior to randomization * Valvular heart disease requiring surgical intervention during the course of the study * History of hospitalization for hyperkalemia or acute renal failure induced by previous aldosterone antagonist treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of serum potassium | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change in serum magnesium | Day 8, Day 15, Day 22, Day 29 |
| Change in blood pressure | Day 8, Day 15, Day 22, Day 29 |
| Change in heart rate | Day 8, Day 15, Day 22, Day 29 |
Countries
Austria, Belgium, Czechia, Denmark, Finland, Germany, Israel, Norway, Poland, Sweden
Outcome results
None listed