Clinical Study Of Eplerenone In Japanese Patients With Chronic Heart Failure (J-EMPHASIS-HF)

Viatris

Status and phase: Completed; Phase 3

Conditions: Heart Failure

Treatments: Drug: Eplerenone; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01115855

A6141114

Details and patient eligibility

About

A study to compare the efficacy and safety of eplerenone in Japanese chronic heart failure patients with placebo.

Full description

The aim of this study was to show consistency with the EMPHASIS-HF trial (NCT00232180), which was defined as a HR of the primary endpoint of below 1.

Enrollment: 221 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Japanese chronic systolic heart failure patients with LVEF =<30% by echocardiography and NYHA II or more
• Patients who receive standard therapy (Angiotensin converting enzyme inhibitors, angiotensin receptor blockers, beta-blocker or diuretic)

Exclusion criteria

• Patients with a myocardial infarction, stroke, cardiac surgery or percutaneous coronary intervention within 30 days prior to randomization.
• Patients with serum potassium >5.0 mmol/L or eGFR <30 ml/min/1.73 m2.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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221 participants in 2 patient groups, including a placebo group

Eplerenone arm

Experimental group

Description:

Add on standard heart failure therapy

Treatment:

Drug: Eplerenone

Placebo arm

Placebo Comparator group

Description:

Add on standard heart failure therapy

Treatment:

Drug: Placebo