Cognitive function in patients with heart failure or aortic valve stenosis

Not yet recruiting

Conditions: I50
I35
F03
I21
Heart failure
Nonrheumatic aortic valve disorders
Unspecified dementia
Acute myocardial infarction

Registration Number: DRKS00034648

Lead Sponsor: niversitätsmedizin Göttingen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 270

Inclusion Criteria

Patient has signed the informed consent form for participation in the study

Exclusion Criteria

Surgery or catheter-based procedures (e.g. PCI, transcatheter edge-to-edge mitral or tricuspid valve repair) planned in the next 3 months after study inclusion. PCI may be performed immediately prior to study inclusion and prior to TAVI.
Women of childbearing age (pregnancy and breastfeeding)
Known active malignant disease with a life expectancy < 1 year
Significant hypotension (RR of <90 mmHg systolic and/or <50 mmHg diastolic)
Renal dysfunction of a GFR <15 ml/min/1.73m2 cu.m.
Presence of additional high-grade aortic valve insufficiency or high-grade mitral valve stenosis
Presence of additional myocardial disease, e.g. myocarditis; HOCM
Previously known high-grade dementia (MoCA < 15 points)
Condition after apoplexy with pronounced residual effects (modified Rankin Scale > 3)

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cognitive impairment measured by neuropsychological testing at the following time points:<br>Arm 1: Day 3-5 after acute myocardial infarction, 1 month, 6 months, 12 months.<br>Arm 2: Before TAVI, 1 month, 6 months, 12 months after TAVI<br>Arm 3: Inclusion date, 1 month, 6 months, 12 months<br>Arm 4: Inclusion date, 1 month, 6 months, 12 months<br>Scores:<br>MoCA (Montreal Cognitive Assessment)<br>MMST (Mini Mental Status Examination)<br>CERAD-Testbatterie (mit Wortliste A) <br>RWT (Sportarten-Früchte; G-R)<br>Rey-Figur (Abzeichnen)<br>ZN / ZNR<br>Rey-Figur (GD I) <br>Uhrentest (Shulman)<br>TAP: Alertness, GoNogo Bed. 1; Geteilte Aufmerksamkeit <br>Rey-Figur (GD II) <br>MWT-B (nur bei Einschluss) <br>BDI-II<br>

Secondary Outcome Measures