Thoraflex EXTEND (Stress Management for People with Heart Disease) - Clinical Trial
Email to Participate
hillary.hood@duke.edu
What is the 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.
What is the Condition Being Studied?
Heart Disease, Worry, and Stress
Who Can Participate in the Study?
Adults ages 40+ who:
- Have a history of heart disease (e.g., stent, heart attack, bypass graft, or angina)
- Have feelings of worry, stress, tension, nervousness, panic, or anxiety
- Are not currently taking medicine to enhance mood
- Are not currently in a formal exercise program
For more information about who can be in this study, please contact the study team at hillary.hood@duke.edu.
Age Group
Adults
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:
- Group 1: Exercise at a local cardiac rehab facility 3 days/week
- Group 2: Medication pill (escitalopram [Lexapro®]) taken daily plus 5 clinic visits
- Group 3: Placebo (inactive pill with no medicine) taken daily plus 5 clinic visits
No matter your group assignment, everyone who participates will:
- Do an exercise stress test
- Have blood draws
- Have an ultrasound (scan) of your blood vessels
- Fill out questionnaires
- Have one follow-up visit 6 months after the study
Study Details
Full Title
Thoraflex Hybrid and Relay Extension Post-Approval Study (EXTEND)
Principal Investigator
Heart Surgeon
Protocol Number
IRB:
PRO00112349
NCT:
NCT05639400
Phase
Phase
N/A
ClinicalTrials.gov
View on ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Participate
Email hillary.hood@duke.edu