Beyond Heart Attacks and Stroke – Can Jardiance Also Protect Against Heart Failure?

By Jeemin Kwon

Two new studies will investigate whether SGLT-2 inhibitor Jardiance impacts heart failure in people with and without diabetes. Jardiance is already approved to lower A1C and reduce the risk of heart-related death

Clinical Trials Identifier: NCT03057977 and NCT03057951

Trial names:

Empagliflozin Outcome Trial in Patients With Chronic Heart Failure with Reduced Ejection Fraction (EMPEROR-Reduced)

and

Empagliflozin Outcome Trial in Patients With Chronic Heart Failure with Preserved Ejection Fraction (EMPEROR-Preserved)

Diabetes type: Anyone, including people without diabetes

What the trial is testing: These studies will compare the effects of Jardiance, an SGLT-2 inhibitor, to a placebo (a “nothing” pill) on heart failure in people with diabetes. Jardiance, which can lower A1C and help with weight loss, is already approved for people with type 2 diabetes. Notably, following a major clinical study, Jardiance became the first diabetes drug to be approved to reduce the risk of heart-related death, including from events like heart attacks and strokes. This new trial is specifically examining heart failure, a chronic condition.

Researchers are recruiting individuals, with or without diabetes and prediabetes, who have one of two types of chronic heart failure:

• The EMPEROR-Preserved study seeks individuals with “heart failure with preserved ejection fraction” – in other words, the heart still has some (still less than a healthy heart) preserved ability to pump blood out.

• The EMPEROR-Reduced study seeks individuals with the type of heart failure which has significantly reduced ability to pump blood out of the heart: “heart failure with reduced ejection fraction.”

What the trials are measuring: Both the EMPEROR-Preserved study and the EMPEROR-Reduced study will record the time until a person is first hospitalized for heart failure or heart-related death. For participants who do not have diabetes at the start of the trial, researchers will also measure time to onset of type 2 diabetes. The studies will also assess quality of life using a questionnaire.

Why is this new/important?: Heart failure is different from heart attacks or sudden cardiac arrest. It occurs when the heart cannot circulate enough blood to the body, either because it can’t pump out enough blood on each beat or because it can’t adequately refill with new blood between beats. Like other heart problems, such as heart attacks and strokes, people with type 2 diabetes are more likely to develop heart failure than people without diabetes. By some estimates, the risk of heart failure for people with diabetes is more than doubled.

These two studies are the first to look at the effect of Jardiance on both varieties of heart failure. Although Jardiance is already known to reduce risk of heart-related death, information about impact on heart failure will provide further support for healthcare providers in deciding what to prescribe. It may also reduce the number of daily pills needed for people with both diabetes and heart conditions. 

Trial length: Both trials may include follow-up with participants for up to 3 years

Trial locations: EMPEROR-Preserved will enroll over 4,000 participants at over 400 participating locations; click here for the full list. EMPEROR-Reduced will enroll about 3,000 participants from diverse locations as well.

Do you qualify?

Eligibility criteria for the EMPEROR-Preserved study include:

• At least 18 years of age

• Diagnosed with heart failure with ejection fraction greater than 40%

• No heart attack, stroke, major heart surgery in the 90 days prior to start of study

• Cannot currently be taking, or have previously taken, an SGLT-2 inhibitor (Jardiance, Farxiga, Invokana, etc.)

• Cannot be on dialysis

• See full list of criteria here

Eligibility criteria for the EMPEROR-Reduced study include:

• At least 18 years of age

• Diagnosed with heart failure with ejection fraction less than 40%

• No heart attack, stroke, major heart surgery in the 90 days prior to start of study

• Cannot currently be taking, or have previously taken, an SGLT-2 inhibitor (Jardiance, Farxiga, Invokana, etc.)

• Cannot be on dialysis

• See full list of criteria here

Where to get more information: For both studies, contact the Boehringer-Ingelheim Call Center at 1-800-243-0127, or at clintriage.rdg@boehringer-ingelheim.com