None listed
Conditions
Brief summary
Background: In patients with chronic heart failure (CHF) depression is common, chronic and more severe than in other groups of cardiac patients. Unfortunately, at the present time in this group of patients, depressed mood is rarely screened for, let alone treated. Many patients have a mild form of depression “minor depression” that is debilitating with consequences that are anything but “minor”. We have data that demonstrate that depression (both major and minor) is a marker of a worse future health, including death, in CHF patients. However, these data do not conclusively answer two questions: 1. Does providing antidepressant medication for people with heart failure and depression improve their mood? 2. Does improving mood with antidepressant medication also improve physical functions related to heart health? Aims: This study, therefore, aims to test the hypothesis that treatment with an antidepressant medication (escitalopram) can improve minor and major depression in depressed patients with CHF. The study will also examine whether by reducing depression, other known medical risk factors that are related to both depression and CHF are changed at the same time. A third part of the study will examine whether there are longer term benefits to hospitalizations and longevity, and finally, genetic testing will done to assess the role of certain genes in the response to treatment.
Interventions
Six months of blinded treatment with oral escitalopram titrated from 5 mg to 20mg daily and maintained at maximum tolerated dose. Participants in the treatment group who have improved to remission by 6 months will be provided with open-label maintenance therapy to 12 months.
Sponsors
Austin Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age = 18 years 2. Systolic heart failure with documented left ventricular ejection fraction (LVEF) < 40% (at some stage of their illness but not necessarily recently) by echocardiography, magnetic resonance imaging, contrast ventriculography, perfusion scanning or gated blood pool scanning (RNVG). 3. If current LVEF > or = 45%, with New York Heart Association (NYHA) Class II – IV functional limitation 4. Optimal, stable CHF therapy. Optimal therapy will include a beta-blocker and an angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB), unless not tolerated. Stable therapy is defined as having no new chronic heart failure (CHF) drug class introduced in the 8 weeks prior to randomisation 5. Diagnosis of Major or Minor Depression (confirmed by clinical interview) 6. Able to read English, give informed consent and comply with study procedures.
Exclusion criteria
1. Currently prescribed an anti-depressant, currently being treated by a psychiatrist or receiving any psychological treatment 2. Severe depression (CDS > or = 140 with severity confirmed on interview) 3. Suicidal ideation (> or = 3 on GRID-Hamilton Depression Score (GRID-HAMD) interview or > or = 2 with confirmation by psychiatrist interview ) 4. Other severe psychiatric disorder (including psychosis, bipolar disorder, substance abuse, severe personality disorder) 5. Cognitive impairment (Mini-Mental Status Exam< 24) 6. Estimated glomerular filtration rate (eGFR) < 30 ml.min-1 7. Currently enrolled in, or at least 30 days not yet elapsed since ending another trial 8. Any of the following within the previous 3 months that are likely to require a period of psychological adjustment: heart failure admission or insertion of a cardiac device, major illness or surgery, severe psychosocial stressor (bereavement, separation, job loss) 9. Exposure to a traumatic event (e.g. assault, natural disaster, car accident) 10. Female patients of child bearing potential who are pregnant, breast feeding, or not using adequate contraceptive precautions 11. Currently attending or planning to attend cardiac rehabilitation or exercise program during the treatment phase.
Outcome results
None listed