Can Farxiga Protect Against Heart Failure in Addition to Lowering Blood Glucose?

By Emma Ryan and Ben Pallant

Two new studies will investigate whether SGLT-2 inhibitor Farxiga impacts heart failure in people with type 2 diabetes and prediabetes

Clinical Trials Identifier: NCT03030235 and NCT03036124

Trial names: Dapagliflozin in Type 2 Diabetes or Prediabetes, and PRESERVED Ejection Fraction Heart Failure (PRESERVED-HF)

AND

Study to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients With Chronic Heart Failure (Dapa-HF)

Diabetes type:

• PRESERVED-HF: Type 2 and prediabetes (for background on prediabetes, see here)
• DAPA-HF: Type 2, prediabetes, and people without diabetes 

What the trial is testing: These studies are testing the effects of Farxiga, an SGLT-2 inhibitor, compared to a placebo (a “nothing” pill) on heart failure in people with diabetes. Farxiga, which can lower A1C and help with weight-loss, is approved for people with type 2 diabetes. It is currently under review in Europe for people with type 1 diabetes. Researchers are recruiting individuals who have type 2 diabetes or prediabetes and one of two types of chronic heart failure:

• The PRESERVED-HF study seeks individuals with the type of heart failure with relatively preserved ability to pump blood out of the heart (called “heart failure with preserved ejection fraction”)

• The Dapa-HF study seeks individuals with the type of heart failure which has significantly reduced ability to pump blood out of the heart (called “heart failure with reduced ejection fraction”).

What the trials are measuring: The shorter PRESERVED-HF study will measure an indicator of heart failure as the primary outcome. Researchers will also look at A1C, weight, blood pressure, ability to exercise, and quality of life.

In the longer Dapa-HF trial researchers will focus on rates of hospitalization, death, or urgent medical visits related to heart failure. The study will also use a questionnaire to measure quality of life changes during the first 8 months.

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 for people with diabetes is more than doubled.

These two studies are the first to look at the effect of Farxiga on both varieties of heart failure. It’s important to know if a drug already approved for diabetes management improves heart-related outcomes, since this type of data gives healthcare providers useful information on what to prescribe. It may also reduce the number of daily pills in those with both diabetes and heart conditions.  

Other SGLT-2 inhibitors are understood to improve heart health: Jardiance is FDA approved to reduce the risk of heart attack and stroke in type 2 diabetes, and research shows that Invokana provides a similar benefit.

Trial length: Three months for PRESERVED-HF, up to three years for Dapa-HF

Trial locations: The PRESERVED-HF study will enroll 320 people with type 2 diabetes or prediabetes in 17 states including California, Florida, Massachusetts, New York, and Texas. All participating locations are listed here.

The Dapa-HF study will enroll 4,500 people at over 500 study locations in more than 30 states as well as more than 20 other countries.

Do you qualify?

Eligibility criteria for the PRESERVED-HF study include:

• At least 19 years of age

• Diagnosed with type 2 diabetes or prediabetes

• If type 2 and not on diabetes medications, A1C between 6.0-6.9%

• If type 2 and on metformin, A1C between 6-11%

• If type 2 and on a blood sugar-lowering medication that is not metformin (such as Jardiance, Invokana, insulin, Victoza, glimepiride, glyburide, etc), A1C between 6.5-11%

• If you have prediabetes, A1C between 5.7-6.5%

• Ejection fraction (EF), a measure of the heart’s ability to pump out blood, of at least 45%

• Taking treatment for heart failure for the past 30 days

• No history of diabetic ketoacidosis (DKA)

• See full list of criteria here

Eligibility for the Dapa-HF study include:

• At least 18 years of age

• Diagnosed with symptomatic heart failure with reduced ejection fraction for at least 2 months.

• Ejection fraction (EF), a measure of the heart’s ability to pump out blood, of less than 40%

• Not on an SGLT-2 inhibitor within the 8 weeks prior to the study, and no previous intolerance of an SGLT-2 inhibitor

• No history of heart attack, stroke, or coronary bypass surgery within the 12 weeks prior to the study.

• See full list of criteria here

Where to get more information:

• For the PRESERVED-HF study, contact Sheryl Windsor at 816-932-9858 or PRESERVED-HF@saint-lukes.org
• For the Dapa-HF study, contact the AstraZeneca Clinical Study Information Center at 1-877-240-9479 or information.center@astrazeneca.com