Heart Failure, Iron deficiency (ID), Mild Cognitive Impairment
Conditions
Brief summary
Changes in cognitive performance at week 12, compared to baseline, as assessed by a global composite score of cognitive function. This score constitutes the average of z-standardized results of the Digit Symbol Substitution Test, Stroop Color Word Interference Task, Trailmaking-Test, CERAD-Wordlist, Digit Span Backwards Test, and Digit Span Forwards Test.
Detailed description
Changes in cognitive performance at week 24, compared to baseline, as assessed by the global composite score of cognitive function (single items for composite score see 3.2.1 Primary Endpoint)., Changes in single measures and domain specific subscores (e.g. frontal executive function, perceptual speed, memory subsystems) of cognitive performance at week 12 and 24 compared to baseline, as assessed by the MoCA Test, Digit Symbol Substitution Test, Stroop Color Word Interference Task, Trailmaking-Test, CERAD- Wordlist, Digit Span Backwards Test, and Digit Span Forwards Test., Reduction in depression from baseline to week 12 and 24, as assessed by HADS, Reduction in general anxiety and heart-focused anxiety from baseline to week 12 and 24, as assessed by HADS and HAF-17., Changes in self-reported quality of life, as assessed by The Kansas City Cardiomyopathy Questionnaire (for HF specific quality of life) and EQ-5D (for general psychological and physical quality of life) from baseline to week 12 and 24.
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in cognitive performance at week 12, compared to baseline, as assessed by a global composite score of cognitive function. This score constitutes the average of z-standardized results of the Digit Symbol Substitution Test, Stroop Color Word Interference Task, Trailmaking-Test, CERAD-Wordlist, Digit Span Backwards Test, and Digit Span Forwards Test. | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in cognitive performance at week 24, compared to baseline, as assessed by the global composite score of cognitive function (single items for composite score see 3.2.1 Primary Endpoint)., Changes in single measures and domain specific subscores (e.g. frontal executive function, perceptual speed, memory subsystems) of cognitive performance at week 12 and 24 compared to baseline, as assessed by the MoCA Test, Digit Symbol Substitution Test, Stroop Color Word Interference Task, Trailmaking-Test, CERAD- Wordlist, Digit Span Backwards Test, and Digit Span Forwards Test., Reduction in depression from baseline to week 12 and 24, as assessed by HADS, Reduction in general anxiety and heart-focused anxiety from baseline to week 12 and 24, as assessed by HADS and HAF-17., Changes in self-reported quality of life, as assessed by The Kansas City Cardiomyopathy Questionnaire (for HF specific quality of life) and EQ-5D (for general psychological and physical quality of life) from baseli | — |
Countries
Germany