Clinical trial NCT01756014: Brain Function and Perfusion in Patients With Heart Failure
Official title: Brain Function and Perfusion in Patients With Heart Failure
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure
Dilated Cardiomyopathy
Perfusion
Cognitive Impairment
Cerebral Hypoperfusion
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2012-12-24
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: * Patients with heart failure due to dilated cardiomyopathy with NYHA II or NYHA II/IV.
* Healthy patients

Brief summary: The investigators will evaluate the determinants of cerebral impairment in patients with non-ischemic heart failure compared to controls, and its relation to cognitive function. They hypothesize that patients with heart failure have impaired brain perfusion and hemodynamic factors are associated with cognitive dysfunction.


Eligibility criteria: Inclusion Criteria Control Group:

* Healthy subject, as assessed by clinician
* Age matched with patient group

Exclusion Criteria Control Group:

* Age \< 18 years
* Carotid artery or intracranial disease, as assessed by echo-doppler (significant stenosis \> 50%)
* Unable or unwilling to undergo MRI
* The presence of ferromagnetic material in or on the body, for example tattoos with ferrous ink or pacemakers or cardiac defibrillators. Also the presence of pregnancy and claustrophobia.
* History of cognitive impairment
* Unable to understand procedures
* Unable or unwilling to provide informed consent

Inclusion Criteria DCM-group:

* Heart failure due to DCM
* 15 patients with NYHA class II
* 15 patients with NYHA class III/IV

Exclusion Criteria DCM-Group:

* Age \< 18 years
* History of myocardial infarction
* History of peripheral artery disease
* History of cerebrovascular disease or
* Carotid artery or intracranial disease, as assessed by echo-doppler (significant stenosis \> 50%)
* History of cognitive impairment
* Unable to undergo MRI (eg pacemaker)
* Unable to understand procedures
* Unable or unwilling to provide informed consent

Primary outcomes:
measure: Determinants of cerebral impairment
timeFrame: Baseline
Secondary outcomes:
measure: Prevalence of cognitive impairment
timeFrame: Baseline
measure: Relation of cognitive impairment with local perfusion
timeFrame: Baseline
measure: Relation of cognitive impairment with the severity of heart failure
timeFrame: Baseline
measure: Relation of cognitive impairment with cardiac output
timeFrame: Baseline
measure: Relation of cognitive impairment with the severity of congestion
timeFrame: Baseline
measure: Relation of cognitive impairment with the decrease in cerebral perfusion
timeFrame: Baseline
measure: The difference of cognitive domains in above relations
timeFrame: Baseline
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Centre Groningen
Study officials:
References:
citation: Erkelens CD, van der Wal HH, de Jong BM, Elting JW, Renken R, Gerritsen M, van Laar PJ, van Deursen VM, van der Meer P, van Veldhuisen DJ, Voors AA, Luijckx GJ. Dynamics of cerebral blood flow in patients with mild non-ischaemic heart failure. Eur J Heart Fail. 2017 Feb;19(2):261-268. doi: 10.1002/ejhf.660. Epub 2016 Nov 14.