N/A
N=128
Exercise and Pharmacotherapy for Anxiety in Cardiac Patients
Anxiety · Cardiovascular Disease
Bottom Line
View on ClinicalTrials.gov: NCT02516332 ↗Enrolled (actual)
128
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcome: Primary: Change in Hospital Anxiety and Depression Scale (HADS), Anxiety — -3.9; -5.7; -3.5 score on a scale — p=0.038
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Lexapro (Drug); Placebo (Drug); Supervised Aerobic Exercise (Behavioral)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- May 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Hospital Anxiety and Depression Scale (HADS), Anxiety |
-3.9; -5.7; -3.5 | 0.038 sig |
| SECONDARY Change in Heart Rate Variability, SDNN (Msec) |
-0.3; -8.7; -1.1 | — |
| SECONDARY Change in Baroreflex Sensitivity, ms/mm Hg |
1.2; 1.3; 1.5 | — |
| SECONDARY Change in Vascular Endothelial Function, Percentage of Dilation |
0.7; 0.5; 0.5 | — |
| SECONDARY Change in Inflammation (C-Reactive Protein, ug/ml) |
-0.2; 0.1; -0.3 | — |
| SECONDARY Change in Urinary Catecholamines (Epinephrine and Norepinephrine, Unit-weighted Z-score) |
0.05; -0.24; 0.36 | 0.011 sig |
| SECONDARY Change in Lipids - Total Cholesterol, LDL (Low-density Lipoprotein), and HDL (High-density Lipoprotein); mg/dL |
-28.2; -15.3; -31.6; -18.6; -9.8; -19.3 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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 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.
Data sourced from ClinicalTrials.gov (NCT02516332). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.