Effects of a Selective Serotonin Reuptake Inhibitor on Morbidity, Mortality and Mood in Patients with Heart Failure and Depression (MOOD-HF-Study) - Project description
Background
Depression und chronic heart failure play very significant roles both clinically and economically. Between 20 and 40 percent of the 4 million people with heart failure in the Federal Republic of Germany also suffer from depression. Heart failure and depression influence each other, with adverse effects on the quality of life, costs, morbidity and mortality. MOOD-HF is the first randomized, controlled trial to study the long-term effect of treatment with a selective serotonin reuptake inhibitor for clinically relevant comorbid depression in patients with heart failure for „hard“ clinical end points. MOOD-HF will thus contribute to the development of evidence-based guidelines.
Objective
The multicentric MOOD-HF study was designed as a two-arm, double-blind and placebo-controlled study to clarify whether treatment with the selective serotonin reuptake inhibitor improves mortality, morbidity, quality of life, psychological well-being and other end points (e.g. health economics, biomarkers, vasoreactivity) in patients with heart failure and clinically relevant comorbid depression, and if so, by what mechanisms. At the same time, the extent to which optimization of the heart failure therapy also leads to improvement in depression will be investigated.
Implementation
Nine German sites are taking part in the study; study management and biometrics are the responsibility of the Coordinating Center for Clinical Trials in Leipzig. The data collection includes the basic record of the Heart Failure Competence Network in a slightly modified form. Seven hundred patients are to be enrolled. The duration of the study for individual patient is a minimum of 12 and a maximum of 24 months. The primary inclusion criterion is a major depression confirmed by a structured clinical interview (SCID). In addition to the study medication, all patients receive optimal treatment for heart failure in accordance with applicable treatment guidelines as well as regular telephone monitoring by nursing staff. The degree of depression, quality of life, anxiety and cognitive functions are monitored throughout the course of the study using standardized and validated psychometric instruments. The follow-up includes meticulous monitoring of patient safety. The study requires close, interdisciplinary cooperation among cardiologists, psychiatrists, psychosomatic specialists and specialized nursing staff and would be impossible without this. A starting event with training and certification of those involved was already held; enrollment of the first patients is scheduled for November 2008.
Added value via networking
A multicenter design is a crucial prerequisite for the implementation of MOOD-HF, as the calculated study power of 700 enrolled patients with heart failure and clinically relevant comorbid depression could not otherwise be achieved within a reasonable period of time. The Heart Failure Competence Network and its affiliated partners offered outstanding conditions for site recruitment. MOOD-HF will enrich the database of the competence network with basic and dynamic process data of patients with systolic heart failure and clinically relevant comorbid depression, thus contributing to the data pool of the network. The data collected here will be made available to network partners for further comparative analyses. Requests can also be sent to the biomaterial bank of the Würzburg study headquarters analogous to the usual procedure in the Heart Failure Competence Network. In addition, the interdisciplinary networking of the study partners provides innovative opportunities for collaboration and new options for improved care of multimorbid patients with heart failure.