Purpose of this Study
We are doing this study to learn more about the effects of exercise and medication on symptoms of worry and stress in adults with heart disease. This study is important because symptoms of worry and stress are risk factors for worsening heart health.
Who Can Participate?
Eligibility
Adults ages 40+ who:<ul>
<li>Have a history of heart disease (e.g., stent, heart attack, bypass graft, or angina) </li>
<li>Have feelings of worry, stress, tension, nervousness, panic, or anxiety</li>
<li>Are not currently taking medicine to enhance mood</li>
<li>Are not currently in a formal exercise program</li></ul>
For more information about who can be in this study, please contact the study team at <a href= "mailto: hillary.hood@duke.edu">hillary.hood@duke.edu.</a>
<li>Have a history of heart disease (e.g., stent, heart attack, bypass graft, or angina) </li>
<li>Have feelings of worry, stress, tension, nervousness, panic, or anxiety</li>
<li>Are not currently taking medicine to enhance mood</li>
<li>Are not currently in a formal exercise program</li></ul>
For more information about who can be in this study, please contact the study team at <a href= "mailto: hillary.hood@duke.edu">hillary.hood@duke.edu.</a>
What is Involved?
If you choose to join this study, you will get a random assignment (fair, equal chance) to 1 of 3 different study groups. Each group will have a different study regimen:<ul>
<li>Group 1: Exercise at a local cardiac rehab facility 3 days/week</li>
<li>Group 2: Medication pill (escitalopram [Lexapro®]) taken daily plus 5 clinic visits</li>
<li>Group 3: Placebo (inactive pill with no medicine) taken daily plus 5 clinic visits</li></ul>
No matter your group assignment, everyone who participates will:<ul>
<li>Do an exercise stress test</li>
<li>Have blood draws</li>
<li>Have an ultrasound (scan) of your blood vessels</li>
<li>Fill out questionnaires</li>
<li>Have one follow-up visit 6 months after the study</li></ul>
<li>Group 1: Exercise at a local cardiac rehab facility 3 days/week</li>
<li>Group 2: Medication pill (escitalopram [Lexapro®]) taken daily plus 5 clinic visits</li>
<li>Group 3: Placebo (inactive pill with no medicine) taken daily plus 5 clinic visits</li></ul>
No matter your group assignment, everyone who participates will:<ul>
<li>Do an exercise stress test</li>
<li>Have blood draws</li>
<li>Have an ultrasound (scan) of your blood vessels</li>
<li>Fill out questionnaires</li>
<li>Have one follow-up visit 6 months after the study</li></ul>
Study Details
Full Title
Thoraflex Hybrid and Relay Extension Post-Approval Study (EXTEND)
Principal Investigator
George
Hughes
Protocol Number
PRO00112349
NCT ID
NCT05639400
Phase
N/A
Enrollment Status
Open to Enrollment