Effects of selective serotonin re-uptake inhibition on MOrbidity, mOrtality and mood in Depressed Heart Failure patients
- Conditions
- Heart failure and co-morbid depressionMental and Behavioural Disorders
- Registration Number
- ISRCTN33128015
- Lead Sponsor
- German Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung [BMBF]) (Germany)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 414
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
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to first event of death or hospitalisation.
- Secondary Outcome Measures
Name Time Method Major secondary outcome: <br>Reduction of the degree of depression as assessed by the Patient Health Questionnaire (PHQ-9) Scale and the Montgomery Asberg Depression Scale (MADRS)<br><br>Further secondary outcomes:<br>1. Days alive out of hospital<br>2. PHQ-GAD-7 (General Anxiety Disorder) scale<br>3. Quality of life as assessed by the 36-item Short Form Health Survey (SF-36), and the Kansas City Cardiomyopathy Questionnaire (KCCQ)<br>4. Cardiovascular mortality<br>5. Cardiovascular morbidity<br>6. Health economy<br>7. Adherence to HF and study medication<br>8. CHF severity<br>9. Parameters of inflammation<br>10. Sympathetic nervous system function<br>11. Escitalopram plasma levels <br>12. Platelet function/coagulation (substudy)<br>13. Vasoreactivity (substudy)