Pharmacological Restoration of mOod in HEART Failure: PRO-HEART
- Conditions
- DepressionChronic systolic heart failureMental Health - DepressionCardiovascular - Other cardiovascular diseases
- Registration Number
- ACTRN12610000223033
- Lead Sponsor
- Austin Health
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 29
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method