Exercise and Pharmacotherapy for Anxiety in Cardiac Patients

Completed · Not applicable · Has a placebo group

Conditions studied: Anxiety, Cardiovascular Disease

In brief

Coronary heart disease (CHD) is the leading cause of death in the United States; more than 600,000 Americans suffer a fatal cardiac event each year. Traditional CHD risk factors such as high blood pressure, smoking, and elevated cholesterol do not fully account for the timing and occurrence of CHD events and individuals with elevated levels of anxiety appear to have a greater risk of cardiovascular events. The present study will examine the impact of aerobic exercise and Lexapro in the treatment of anxiety and cardiovascular biomarkers among individuals with CHD.

Key facts

Study ID

NCT02516332

Run by

Duke University

People needed

128

Starts

2015-12-01

Expected to finish

2021-05-01

Last updated by the study team

2021-06-11

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men and women with documented CHD (i.e., a prior MI, coronary revascularization procedure, or >70% stenosis in at least one coronary artery)
• Age > 39 years
• Patients also will have an anxiety symptom severity score of at least 8 on the Hospital Anxiety and Depression-Anxiety scale (HADS-A) or a DSM-5 diagnosis of an Anxiety Disorder, such as General Anxiety, Social Anxiety, or Panic Disorder.
• The study team plans to actively recruit women and minorities, with at least 50% women and 25% minorities.

You may not qualify if…

• An MI or coronary revascularization procedure (i.e., CABG or percutaneous coronary intervention) within the last 3 months
• Unstable angina
• Severe left ventricular dysfunction (ejection fraction <30%) or decompensated heart failure
• Unrevascularized left main coronary artery stenosis >50%
• Complete Pacemaker dependence
• Resting BP >200/120 mm Hg
• Conditions that would preclude randomization to either the drug (e.g., prolonged QT interval, known allergy to or intolerance of escitalopram) or exercise (e.g., musculoskeletal problems or abnormal cardiac response to exercise)
• Patients with a primary psychiatric diagnosis other than Anxiety Disorder will be excluded, including patients with PTSD, OCD, or any of the following DSM-5 diagnoses:
• Dementia, delirium;
• Schizophrenia, Schizoaffective, or other psychotic disorder;
• Psychotic features including any delusions or hallucinations; or
• Current alcohol or other substance abuse disorder.
• Similarly, patients who pose an acute suicide or homicide risk or who, during the course of the study, would likely require treatment with additional psychopharmacologic agents will not be enrolled.
• Patients will also be excluded if they are taking other medications that would preclude assignment to either drug or exercise conditions (e.g., clonidine, dicumarol, anticonvulsants, and MAO inhibitors) or are taking herbal supplements with purported mood effects (e.g., St. John's Wort, valerian, ginkgo).
• Patients already engaged in regular exercise (at least 30 minutes >1x/week) will not be enrolled.
• Finally, pregnant women will be excluded from participation.

Where it is running

• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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