Research projects

The Melbourne depression in heart failure collaborative – medication trial

Principal researchers

Assoc. Prof David Hare

Institution

University of Melbourne
Austin Hospital

Funding

$409,694 from beyondblue – Total funding $819,389

Co-funded with

Heart Foundation

Award type

Cardiovascular Disease and Depression Strategic Research Program

Project completion year

2014

Project brief

In patients with damaged heart muscle (CHF patients), depression is common. It is more severe and doesn’t improve as easily as in other groups of cardiac patients. Depressed mood is rarely screened for, let alone treated, in this group of patients. Many patients have a milder form, ’minor depression’ that is in itself debilitating, but is not considered a depressive illness and is often not treated either.

The researchers have data which demonstrate that depressed mood is a major marker of a worse future health, including death, in CHF patients. This is for patients with severe or major depression as well as those with milder, or minor, depression. However, there are no large significant studies that demonstrate that the depression in these patients can be improved, let alone impinge on the eventual prognosis of the cardiac condition itself. Even if treating the depression does not prevent death in these patients, the social consequences of the depression are immense – the relief of the suffering associated with depression would be a fantastic outcome in its own right.

This study will test the hypothesis that minor and major depression can be improved in CHF patients with medication. In studies using medications, we know that some people improve when they receive a placebo. In this study, half the patients will receive the active anti-depressant medication and half will receive placebo.

The study will also examine whether, by reducing depression, other known medical risk factors (related to both depression and CHF) are also improved. This can give some indication of how depression might be related to poor cardiac outcomes and if treating depression can reduce hospitalisations and possibly even death.

Specific aims

Primary

1. Compared with placebo, treatment of depressed systolic heart failure patients with escitalopram will result in a significant improvement in symptoms of depression at six months, when measured using the Hamilton Depression Rating Scale.

Secondary

2A. Compared with placebo, treatment of depressed systolic heart failure patients with escitalopram will result in a significant improvement in symptoms of depression at six months, when measured using the Cardiac Depression Scale.

2B. The improvement in depression of heart failure patients treated with escitalopram will parallel improved autonomic function, as principally measured by HRV sympatho-vagal balance in the frequency domain.

2C. The improvement in depression will parallel a reduction in pro-inflammatory cytokines.

2D. The improvement in depression will parallel a reduction in BNP.

2E. Improvement in depression will parallel increased perceived emotional support.

2F. Improvement in depression will be moderated for persons with higher baseline hopelessness.

2G. To allow comparison with previous studies that have used the BDI that, compared with placebo, treatment of depressed systolic heart failure patients with escitalopram will result in a significant improvement in symptoms of depression at six months, when measured using the BDI-II.

Tertiary

At 12 months (six months after completion of the randomised pharmacological study phase):

3A. Mortality will be lower in those originally randomised to escitalopram.*

3B. Total days of hospital admission will be less in those originally randomised to escitalopram.

*Mortality will be assessed using the Australian National Death Registry but the study is not powered for this as an end-point.

The study will inform and shape international management guidelines for heart failure patients with a consequent major impact on the management of depression in these patients. The study will be unique in that it is the only one to address minor as well as major depression.

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