Completed

ARTS-HFSafety and Efficacy Evaluation of BAY94-8862 in Patients with Worsening Chronic Heart Failure, Type 2 Diabetes, and Chronic Kidney Disease

Study Aim

This study aims to evaluate the safety and effectiveness of BAY94-8862 in patients with worsening chronic heart failure, type 2 diabetes, and chronic kidney disease, by measuring the percentage of participants with a significant decrease in NT-proBNP, a heart failure indicator, after 90 days of treatment.

What is being tested

Finerenone (BAY94-8862)

+ Placebo

+ Finerenone (BAY94-8862)

Drug

Who is being recruted

Cardiovascular Diseases

+ Heart Diseases

+ Heart Failure

Over 18 Years

+15 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2

Interventional

Study Start: June 2013

See protocol details

Summary

Principal SponsorBayer

Last updated: July 6, 2021

Sourced from a government-validated database.Claim as a partner

Study start date: June 17, 2013

Actual date on which the first participant was enrolled.

This study focuses on a new drug called BAY94-8862, which is taken orally. The main goal is to see if it's safe and effective for people who are hospitalized due to worsening chronic heart failure. This condition is accompanied by either type 2 diabetes with or without chronic kidney disease, or chronic kidney disease alone. The study compares BAY94-8862 to another drug already in use for heart failure treatment, called eplerenone. The hope is that this new drug could offer improved care for those dealing with these complex health issues. During the study, participants receive different doses of BAY94-8862. The researchers then measure the levels of a specific substance in the blood, known as N-terminal pro-B type natriuretic peptide (NT-proBNP). This substance is a common indicator of heart failure. By checking the decrease in NT-proBNP levels after 90 days, the study aims to understand how well the drug works. This could help determine if BAY94-8862 is a promising treatment option for those with chronic heart failure and related conditions.

NCT01807221

Principal SponsorBayer

Last updated: July 6, 2021

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

1066 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesHeart DiseasesHeart Failure

Criteria

9 inclusion criteria required to participate

Blood potassium <= 5.0 mmol/L at screening

Left ventricular ejection fraction (LVEF) <= 40%

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

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

Show More Criteria

6 exclusion criteria prevent from participating

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

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

Cardiogenic shock

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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

6 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Oral - 2.5mg once daily (OD) for 30 days. Potential up-titration to 5mg OD after 30 days or 60 days. Treatment duration 90 days. Placebo OD for 90 days.

Group II

Experimental

Oral - 5mg OD for 30 days. Potential up-titration to 10 mg OD after 30 days or 60 days. Treatment duration 90 days. Placebo OD for 90 days.

Group III

Experimental

Oral - 7.5mg OD for 30 days. Potential up-titration to 15 mg OD after 30 days or 60 days. Treatment duration 90 days. Placebo OD for 90 days.

Group IV

Experimental

Oral - 10mg OD for 30 days. Potential up-titration to 20 mg OD after 30 days or 60 days. Treatment duration 90 days. Placebo OD for 90 days.

Group 5

Experimental

Oral - 15mg OD for 30 days. Potential up-titration to 20 mg OD after 30 days or 60 days. Treatment duration 90 days. Placebo OD for 90 days.

Group 6

Active Comparator

Oral - 25mg every other day (EOD). Potential up-titration to 25mg OD after 30 days and 50mg OD after 60 days.Placebo OD for 90 days.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 172 locations

Birmingham, United StatesOpen in Google Maps

La Jolla, United States

Los Angeles, United States

Jacksonville, United States

Completed172 Study Centers