Trying to level the score against Heart Failure with Pulmonary Hypertension?

You are not alone. Learn about a clinical study in people with Heart Failure with Pulmonary Hypertension.

Life with PH-HFpEF can feel like a constant struggle. The physical limitations and stress on you and your loved ones can feel debilitating, and symptoms can often be mistaken for other diseases, making diagnosis a frustrating process.  Plus, there is no approved treatment.

The LEVEL-2 Study hopes to change that.

About the Study

The LEVEL-2 Study is testing whether a study medication relieves  pressure in the heart and lungs in people with PH-HFpEF.

The study medication is an oral capsule containing a medicine called levosimendan. Levosimendan is used in many countries to treat advanced Heart Failure. However, it is not currently approved for PH-HFpEF, which is why it is considered investigational.

The LEVEL-2 Study consists of a treatment period ranging from 26–52 weeks, followed by an open-label extension period where all participants can receive levosimendan for up to 1 year (52 weeks). There are approximately 16 clinic visits and 14 phone calls for participants who complete the entire study. All clinic visits will involve assessments of participants’ exercise capacity, heart health, and other tests.

During the blinded treatment period (“blinded” means neither you nor the study staff will know which study treatment you are receiving), participants will receive either the study medication or a placebo, which looks like the study medication but does not contain active medication. Participants have a 66% chance of receiving the study medication or a 33% chance of receiving the placebo.

After the blinded treatment period, participants have the option to enter the 1-year extension phase, where all participants receive the study medication.

You may be eligible if you

Have Heart Failure and experience these symptoms:

Shortness of breath
Swollen ankles
Walking slower
Other symptoms of PH-HFpEF

Other requirements apply.

What happens if I participate?

If you qualify and decide to participate

A study doctor will closely monitor you, your symptoms, and overall health
All study-related procedures and study medication will be provided at no cost
Transportation may be provided if you need assistance
You may be able to continue your current medication regimen
You may have the opportunity to help advance scientific knowledge about PH-HFpEF

Your safety is the highest priority while participating

If you have questions or concerns at any point throughout the study, please speak to a study staff member.

Your participation in the LEVEL-2 Study is completely voluntary, and you are free to withdraw at any time, for any reason, without penalty or effect on your medical care. Talk to your doctor if you have any questions about  PH-HFpEF, its symptoms, or study participation.

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About PH-HFpEF

Pulmonary Hypertension (PH) with Heart Failure with Preserved Ejection Fraction (HFpEF) is a debilitating, often fatal disease. Approximately 2 million people in the United States have PH-HFpEF, though numbers could be higher, as the condition is significantly underdiagnosed.

Having PH-HFpEF means your heart struggles to fill with enough blood. This causes pressure and congestion of blood in the veins connected to your heart and lungs – kind of like a traffic jam in the veins.

PH-HFpEF makes people feel out of breath even from light physical activity, such as walking. Other symptoms include swelling in your legs, difficulty breathing, and a rapid, pounding heartbeat.

The LEVEL-2 Study is evaluating whether a study medication relieves pressure in the heart and lungs in people with PH-HFpEF.

LEVEL-2 includes a Screening Period, a Treatment Period, a Safety Period, an Optional Extension Period, and a Follow-up Period.

Screening Period (up to 45 days): At least one clinic visit for assessments to confirm if you qualify. This may require a right heart catheterization (RHC) and other procedures. (Ask your doctor for more information about RHC)
Treatment and Safety Period (26–52 weeks): Daily doses of either the study medication or a placebo, up to 8 clinic visits and up to 7 phone calls
Optional Extension Period (about 1 year): Daily doses of the study medication with about 7 clinic visits and 5 phone calls
Follow-up Period (about 2 weeks): Two phone calls to check your symptoms after you stop taking the study medication

A study medication is a drug that is not approved for use by doctors for the condition being studied. Study medications are tested during clinical studies to see if they are safe and effective for a specific medical condition and/or group of people. Study medications are not approved by a health authority for use, as safety and effectiveness have not been established.

To help you decide whether to participate, the study team will explain the details of the study and provide you with an Informed Consent Form (ICF) that includes study specifics, such as its purpose, length, required procedures, potential benefits, and risks of participation. You will have the opportunity to ask questions and decide if participation is right for you. If you decide to join the study, you will be asked to sign the ICF.