Oral Nitrite for Pulmonary Hypertension + Heart Failure

STUDY BASICS

Have you been told by your doctor that you have heart failure? If so, you may be able to participate in a research study to find out if oral nitrite supplements can lower blood pressure in the lungs and improve the ability to move and/or exercise. Compensation provided.

STUDY PURPOSE

Heart failure with preserved ejection fraction, or diastolic heart failure, is a condition in which the heart muscle is stiff and causes pressure to build up in the blood vessels of the lungs. The high blood pressure in the lungs, or pulmonary hypertension, can make it hard to breathe, particularly with exertion or exercise, and can lead to worsening heart function.

The purpose of this study is to help researchers find out if daily oral nitrite supplements can lower blood pressure in the lungs and improve the ability to move and/or exercise in people who have pulmonary hypertension and heart failure. Nitrites come from a variety of foods we eat and play an important role in regulating blood flow.

COULD THIS STUDY BE RIGHT FOR YOU?

• Ages 18 and up
• Diagnosed with heart failure
• Do not smoke
• Not pregnant or breastfeeding

WHAT PARTICIPANTS CAN EXPECT

Study participation involves up to 14 visits over about 7 months. It is important to know that participants in this study will be randomly assigned (like the flip of a coin) to receive 10 weeks of either nitrite capsules or placebo. The placebo looks and tastes like the nitrite capsules, but does not contain any nitrite.

After you have completed 10 weeks of either the nitrite capsules or the placebo, you will stop taking the study drug for 2 weeks. Following this 2 week break, people who were assigned to receive nitrite will be given the placebo, and people who were assigned to receive placebo will receive nitrite. You will then take the new pills for an additional 10 weeks. During study visits, participants will have a number of tests and assessments, including blood draws, echocardiogram, heart catheterizations, physical exams, exercise tests, breathing tests, and others.