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Cognitive Function, Depression, Anxiety, and Quality of Life in Chronic Heart Failure Patients with Iron Deficiency with and without Anaemia: Effects of Intravenous Iron (Ferric Derisomaltose) CogFer-HF Study

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515046-17-00
Acronym
Kognition
Enrollment
40
Registered
2024-08-20
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, Iron deficiency (ID), Mild Cognitive Impairment

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

Universitaetsmedizin Goettingen
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026