An In Depth Cardiovascular Study of Lisdexamfetamine (LDX; Vyvanse) in Healthy and Treated Hypertensive Adults With Attention Deficit Hyperactivity Disorder (ADHD)

The purpose of this research study is to learn about the effects of a medication called
Vyvanse on the heart (cardiovascular system). The U.S. Food and Drug Administration (FDA)
has approved Vyvanse for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
People who have ADHD have trouble paying attention, organizing, and planning; these symptoms
can cause problems at work, socially and at home.

Vyvanse (also known as Lisdexamfetamine) is an amphetamine (a stimulant). Amphetamines
increase alertness and activity. They are considered safe and effective for treating ADHD
in children. Less is known about the safety and effectiveness of stimulants when they are
used to treat adults with ADHD. There have been some reports of sudden death in children
and adults treated with stimulants. There is no definite evidence that the deaths were
related to the use of stimulants. However, the deaths have raised questions about the
effects that stimulants might have on such things as blood pressure and heart rate.

The study will involve measuring your blood pressure both at home and in the office as well
as cardiovascular tests at the main campus of MGH. The cardiovascular tests involved in the
study are the echocardiograph (ultrasound of the heart) and cardiopulmonary exercise test
(also called stress test; subjects exercise on a bicycle while measuring their heart
activity and breathing is monitored by cardiologists).

The investigators predict to see changes in blood pressure and heart rate (average increase
of heart rate 3-7 bpm, 1-5 mmHg blood pressure) as shown in other clinical studies. The
investigators predict that cardiovascular tests, such as the stress test, will show higher
resting heart rate and lower heart rate recovery during exercise on LDX in comparison to
exercise off LDX. However, the investigators do not expect to see any changes in heart and
lung functioning on LDX as compared to off LDX.