Brain Function and Perfusion in Patients With Heart Failure

NCT01756014 | Unknown

• 1 other identifier: BRAIN-HF
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Dilated Cardiomyopathy; Perfusion; Cognitive Impairment; Cerebral Hypoperfusion

Outcome Measures

Primary Outcomes (1)

• Determinants of cerebral impairment

  Determinants of cerebral impairment in patients with heart failure compared to controls, where cerebral impairment is defined as decreased cognitive function and cerebral hypoperfusion

  Baseline

Secondary Outcomes (7)

• Prevalence of cognitive impairment

  Baseline

• Relation of cognitive impairment with local perfusion

  Baseline

• Relation of cognitive impairment with the severity of heart failure

  Baseline

• Relation of cognitive impairment with cardiac output

  Baseline

• Relation of cognitive impairment with the severity of congestion

  Baseline

Study Arms (3)

Controls

Age matched healthy subjects

Mild DCM

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

Severe DCM

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

* Patients with heart failure due to dilated cardiomyopathy with NYHA II or NYHA II/IV. * Healthy patients

You may qualify if:

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

You may not qualify if:

• 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
• Heart failure due to DCM
• patients with NYHA class II
• patients with NYHA class III/IV
• 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%)

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Centre Groningen

Groningen, Provincie Groningen, 9700 RB, Netherlands

RECRUITING

Related Publications (1)

• 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.

  PMID: 27862767 DERIVED

MeSH Terms

Conditions

Heart Failure; Cardiomyopathy, Dilated; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Cardiomegaly; Cardiomyopathies; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Adriaan A Voors, MD/PhD

CONTACT

+31 50 3612355; a.a.voors@umcg.nl

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr.

Study Record Dates

• First Submitted: December 19, 2012
• First Posted: December 24, 2012
• Study Start: January 1, 2012
• Primary Completion: December 1, 2012
• Last Updated: December 24, 2012

Record last verified: 2012-12

Locations

NL (1)