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Clinical Trials/ISRCTN33128015
ISRCTN33128015
Completed
Phase 4

Effects of selective serotonin re-uptake inhibition on MOrbidity, mOrtality and mood in Depressed Heart Failure patients

German Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung [BMBF]) (Germany)0 sites414 target enrollmentMay 10, 2007
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ConditionsHeart failure and co-morbid depressionMental and Behavioural Disorders

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Heart failure and co-morbid depression
Sponsor
German Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung [BMBF]) (Germany)
Enrollment
414
Status
Completed
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 10, 2007
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
German Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung [BMBF]) (Germany)

Eligibility 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

  • •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

Outcomes

Primary Outcomes

Not specified

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