Metformin for Heart and Lung Health Study

STUDY BASICS

Are you overweight and experiencing shortness of breath or do you have high blood pressure? Or, have you been diagnosed with pulmonary hypertension and heart failure? If so, you may be able to participate in a research study to help find out if the medication metformin can lower blood pressure in the lungs and improve the ability to move and exercise. Compensation provided.

STUDY PURPOSE

Pulmonary hypertension is high blood pressure in the arteries of the lungs. Over time, this type of high blood pressure makes it difficult for the heart to pump blood through the lungs—a condition that can lead to heart failure. Many people with pulmonary hypertension and heart failure are not aware that they have the condition. Common causes of heart failure include being overweight, having high blood pressure, or having heart conditions such as atrial fibrillation or coronary artery disease. People with pulmonary hypertension and heart failure may feel tired or weak, experience shortness of breath during exercise or other activities, and have swelling in the legs and feet. Medications and lifestyle changes improve symptoms for some people, but the condition can be difficult to treat. The purpose of this study is to find out if a medication called metformin can lead to better health outcomes and improve the ability to move and exercise in people who have pulmonary hypertension and heart failure. Metformin is a commonly-used diabetes treatment, but recent research has shown that metformin may also lower blood pressure in the lungs and decrease the workload of the heart. Researchers hope their findings will lead to better ways to treat people with heart disease in the future.

COULD THIS STUDY BE RIGHT FOR YOU?

• Ages 18 and up
• At least one of the following: - Diagnosed with pulmonary hypertension and heart failure - Currently taking medication for high blood pressure - Overweight and experiencing shortness of breath
• Not currently taking the medication metformin
• Do not currently smoke
• Not pregnant or breastfeeding

WHAT PARTICIPANTS CAN EXPECT

Participants will have an initial 2-3 day screening period to confirm their diagnosis and find out if they are eligible for the study. If eligible, participation involves up to 14 visits over about 7 months. Participants will be randomly assigned (like the flip of a coin) to receive 12 weeks of metformin followed by 12 weeks of placebo, or 12 weeks of placebo followed by 12 weeks of metformin. The placebo looks just like the metformin but has no effect. Study-related procedures and assessments include medical history, physical exams, blood draws, pregnancy tests if applicable, walking and exercise tests, stress test, echocardiogram, heart catheterization, muscle biopsy, questionnaires, and other tests as needed.