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Rationale and design of a randomised, controlled, multicenter trial investigating the effects of selective serotonin re‐uptake inhibition on morbidity, mortality and mood in depressed heart failure patients (MOOD‐HF)
Author(s) -
Angermann Christiane E.,
Gelbrich Götz,
Störk Stefan,
Fallgatter Andreas,
Deckert Jürgen,
Faller Hermann,
Ertl Georg
Publication year - 2007
Publication title -
european journal of heart failure
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 5.149
H-Index - 133
eISSN - 1879-0844
pISSN - 1388-9842
DOI - 10.1016/j.ejheart.2007.10.005
Subject(s) - medicine , escitalopram , heart failure , mood , context (archaeology) , depression (economics) , pharmacotherapy , randomized controlled trial , quality of life (healthcare) , antidepressant , clinical endpoint , intensive care medicine , placebo , physical therapy , anxiety , psychiatry , paleontology , alternative medicine , nursing , macroeconomics , pathology , biology , economics
Background Depression and chronic heart failure (CHF) are common conditions, both of which are clinically and economically highly relevant. Major depression affects 20–40% of CHF patients and predicts adverse outcomes in terms of quality of life, morbidity and mortality as well as health care expenditure, independent of other factors of prognostic relevance. Aims The purpose of the MOOD‐HF trial is to clarify whether antidepressant pharmacotherapy improves outcome in CHF patients, and if so by which mechanism(s). Methods MOOD‐HF is a prospective, randomised, double‐blind, placebo‐controlled, 2‐armed, parallel‐group multicenter trial investigating the effects of the serotonin re‐uptake inhibitor (SSRI) escitalopram on morbidity and mortality (primary endpoint), severity of depression, anxiety, cognitive function, quality of life and health care expenditure in 700 patients with symptomatic systolic CHF and major depression diagnosed by structured clinical interview. All patients will receive optimised pharmacotherapy for CHF. Duration of follow‐up, including close safety monitoring, is 12–24 months from randomisation. Perspective MOOD‐HF is the first prospective randomised controlled trial to assess the effects of antidepressant pharmacotherapy on hard somatic endpoints, the mechanism(s) of action of SSRI treatment, as well as safety in New York Heart Association functional class II‐IV CHF patients. The results are expected to promote the development of evidence‐based recommendations for managing depression in the context of CHF. Trial registration ISRCTN.org . Identifier: ISRCTN33128015