Heart failure and co-morbid depression Mental and Behavioural Disorders
Conditions
Interventions
Current interventions as of 15/04/2014:
1. Experimental intervention: nurse support and cardiological care and escitalopram 10 to 20 mg/day orally (p.o.)
2. Control intervention: nurse support and ca
Sponsors
German Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung [BMBF]) (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged more than 18 years 2. Stable systolic chronic heart failure (CHF) (New York Heart Association [NYHA] II to IV) with left ventricular ejection fraction (LVEF) less than 45% 3. Current comorbid episode of major depression confirmed by Structured Clinical Interview for Diagnostic and Statistical Manual for mental disorders - fourth edition (DSM-IV) (SCID) 4. Written informed consent
Exclusion criteria
Exclusion criteria: Current inclusion criteria as of 15/04/2014: 1. Current treatment with a selective serotonin re-uptake inhibitor (SSRI) 2. Previous treatment failure with escitalopram 3. Acute myocardial infarction (less than three months), acute cardiac decompensation, recent (less than three months) or planned (less than 12 months) cardiac surgery 4. Advanced renal failure (Modification of Diet in Renal Disease [MDRD] less than 30 ml/min) 5. Thyreotoxicosis 6. Reduced life expectancy due to other co-morbidity (e.g. malignancy) 7. Moderate or severe hepatic insufficiency (plasma levels of hepatic enzymes more than threefold of the upper level of the normal range) 8. Known evidence of major psychiatric comorbidity: 8.1. Imminent risk for or history of attempted suicide 8.2. Schizophrenia and spectrum disorders 8.3. Bipolar affective disorder 8.4. Current substance disorder 8.5. Moderate and severe Dementia 8.6. Severe depressive episode with psychotic features 9. Other contraindications against therapy with escitalopram (according to product information) 10. Participation in another clinical trial 11. Inability to comply with PHQ-9 and/or SCID testing and/or telephone monitoring for mental or linguistic reasons or lack of access to telephone 12. Pregnancy or nursing period 13. Women with child bearing potential without effective contraception during the conduct of the trial 14. Expected low compliance with the visit schedule or telephone monitoring (e.g., due to comorbidity or travel distance to the trial site) 15. Patients with normal ventricular activation (no bundle branch block (total or incomplete), no other intraventricular conduction delay and no pacemaker) and known QTc* prolongation = 500 ms OR inborn long QT syndrome 16. Patients with current treatment with drugs inducing QT prolongation, such as antiarrhythmic drugs class IA and III, anti-psychotics, tricyclic antidepressants Previous inclusion criteria: 1. Current treatment with a selective serotonin re-uptake inhibitor (SSRI) 2. Previous treatment failure with escitalopram 3. Acute myocardial infarction (less than 3 months), acute cardiac decompensation, recent (less than 3 months) or planned (less than 12 months) cardiac surgery 4. Advanced renal failure (Modification of Diet in Renal Disease [MDRD] less than 30 ml/min) 5. Thyreotoxicosis 6. Reduced life expectancy due to other co-morbidity (e.g. malignancy) 7. Moderate or severe hepatic insufficiency (plasma levels of hepatic enzymes more than threefold of the upper level of the normal range) 8. Known evidence of major psychiatric comorbidity: 8.1. Imminent risk for or history of attempted suicide 8.2. Schizophrenia and spectrum disorders 8.3. Bipolar affective disorder 8.4. Current substance disorder 8.5. Dementia 8.6. Severe depressive episode with psychotic features 8.7. Delirium 9. Other contraindications against therapy with escitalopram (according to product information)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to first event of death or hospitalisation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Major secondary outcome: Reduction of the degree of depression as assessed by the Patient Health Questionnaire (PHQ-9) Scale and the Montgomery Asberg Depression Scale (MADRS) Further secondary outcomes: 1. Days alive out of hospital 2. PHQ-GAD-7 (General Anxiety Disorder) scale 3. Quality of life as assessed by the 36-item Short Form Health Survey (SF-36), and the Kansas City Cardiomyopathy Questionnaire (KCCQ) 4. Cardiovascular mortality 5. Cardiovascular morbidity 6. Health economy 7. Adherence to HF and study medication 8. CHF severity 9. Parameters of inflammation 10. Sympathetic nervous system function 11. Escitalopram plasma levels 12. Platelet function/coagulation (substudy) 13. Vasoreactivity (substudy) | — |
Countries
Germany
Outcome results
None listed