Thoraflex EXTEND (Stress Management for People with Heart Disease)

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:
  • 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.

What is Involved?

Description

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

George
Hughes

Protocol Number

PRO00112349

NCT ID

NCT05639400

Phase

N/A

Enrollment Status

Open to Enrollment
ClinicalTrials.gov