Trying to level the score against heart failure with pulmonary hypertension?
You are not alone. Learn about a clinical study for 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 Study hopes to change that.
About the Study
The LEVEL Study is testing whether a study medication may relieve pressure in your heart and lungs. This may improve PH-HFpEF symptoms and make it easier to do everyday physical activities.
The study medication is an oral tablet 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 study lasts 12 weeks and has the option of a 2-year extension. There are approximately 13 clinic visits and 9 phone calls in total. All clinic visits will involve assessments of your exercise capacity, heart health, and other tests.
During the first 3 months (12 weeks), participants will receive either the study medication or a placebo, which looks like the study medication but does not contain active medication. Patients have a 50/50 chance of receiving the study medication or placebo.
After 3 months, participants have the option to enter the 2-year extension phase, where all participants receive the study medication.
You may be eligible if you
- Are aged 18 to 85 years
- Have heart failure and experience these symptoms:
- Shortness of breath
- Swollen ankles
- Walking slower
- Feeling faint
Other requirements may apply.
Why 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
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 LEVEL 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 about trial participation.
About PH-HFpEF
Pulmonary hypertension (PH) resulting from 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.