Brain Function and Perfusion in Patients With Heart Failure

NCT ID: NCT01756014

Last Updated: 2012-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Failure Dilated Cardiomyopathy Perfusion Cognitive Impairment Cerebral Hypoperfusion

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Controls

Age matched healthy subjects

No interventions assigned to this group

Mild DCM

Heart failure patients with dilated cardiomyopathy (DCM) with NYHA-functional class II

No interventions assigned to this group

Severe DCM

Heart failure patients with dilated cardiomyopathy (DCM) with NYHA-functional class III/IV

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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


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

Exclusion Criteria

* 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


* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Medical Center Groningen

OTHER

Sponsor Role lead

Responsible Party

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A.A.Voors

Prof. dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Medical Centre Groningen

Groningen, Provincie Groningen, Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Adriaan A Voors, MD/PhD

Role: CONTACT

Phone: +31 50 3612355

Email: [email protected]

Facility Contacts

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Adriaan A Voors, MD/PhD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 27862767 (View on PubMed)

Other Identifiers

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BRAIN-HF

Identifier Type: -

Identifier Source: org_study_id