Emperor Heart Failure Study

Emperor Heart Failure Studies

What is a clinical research study?

A clinical research study is a scientific way to answer specific questions such as how safe or effective a potential new medication is in treating a certain condition. Clinical research studies have to be done before a new medication can be approved for use in patients. Without clinical research studies, new medications would not become available and medical advances are less likely to happen.

Emperor Heart Failure Studies
Emperor Heart Failure Studies 1

What is chronic heart failure?

Chronic heart failure is a condition where the heart cannot pump blood as efficiently as it should. Blood pumped out by the heart contains a lot of oxygen, which your body needs to function properly. There are two types of chronic heart failure – preserved ejection fraction and reduced ejection fraction. In patients with reduced ejection fraction, the heart does not use enough force to pump blood out of the heart. In patients with preserved ejection fraction, the heart is still able to pump most of the blood out, but the heart muscles do not relax enough to let blood in during filling. In both types of heart failure, the condition worsens over time. Current medications for heart failure do not always effectively keep people out of the hospital or help them to live longer. New treatment options are needed to give patients with heart failure more time before their condition worsens.

About the EMPEROR Studies

The EMPEROR Studies are looking at how effective and safe an investigational medication is in treating patients with chronic heart failure. In the EMPEROR Studies the investigational medication will be compared with placebo (something that looks the same as the investigational medication but has no active ingredients). 

The EMPEROR studies will include up to 10,000 patients. 

Everyone who takes part in the studies will also continue to receive routine care for heart failure.

What is the investigational medication?

The investigational medication in this study is already approved in a number of countries for patients with type 2 diabetes. It reduces the amount of glucose (sugar) in the blood by increasing the amount of glucose that is passed in the urine. It is thought that the investigational medication may be able to help patients with heart failure. 

What will happen during the EMPEROR Studies?

Your participation in the study could last for about 3 years, but it could be longer or shorter. The studies will continue until they have obtained enough information on the  study medication. The studies will involve the following periods:   

Screening Period
(up to 4 weeks)

To find out if the study is right for you, the study doctor will ask some questions and perform some tests.

Treatment Period
(about 3 years)

You will visit the study center 5 times in the first year. After this, you will visit once every 6 months and the study doctor or member of the study team will contact you by telephone 3 months after each clinic visit. You will take the study medication (investigational medication or placebo) as a tablet once daily, in the morning.

Follow-up period
(up to 1 month)

You will visit the study center twice: once when you stop taking the study medication, and once about 30 days after your last dose. The study doctor will check your health and ask you questions about how you are feeling.

Before some of your study visits, you will need to fast (no food or drink) for 10‒16 hours before your study visit.

Which tests and assessments will be performed?

Physical Examination

A general health assessment, including measurements of your height and weight.

Vital Signs

Your heart rate, body temperature, and blood pressure will be checked.

Electrocardiogram (ECG)

A check of the health and rhythm of your heart.

Emperor Heart Study Laboratory tests

Laboratory Tests

The study doctor will take blood and urine samples for a variety of tests.

Emperor Heart Study Questionnaires

Questionnaires

During most study visits, you will be asked some questions about how heart failure affects you, such as its effect on your daily activities and quality of life.

Emperor Heart Study Questions

Questions about your health and medications

You will be asked how you have been feeling, if you have had any health problems, about any medications you have taken recently, including new medication and dose changes, and about any additional visits to your doctor or hospitalizations.


Who Can Take Part?

You may be able to join if you:

Emperor Heart Failure Studies 2

If you want to participate in an Emperor Heart Study, please fill out the Emperor Study Participation Form Below.

I want to participate in an Emperor study.

Emperor Heart Failure Studies
Boehringer Ingelheim International GmbH
Lilly

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