Brain Function and Perfusion in Patients With Heart Failure

Heart Failure Clinical Trial

— BRAIN-HF  

Official title:

Brain Function and Perfusion in Patients With Heart Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01756014
• Other study ID #: BRAIN-HF
• Status: Recruiting
• Phase: N/A
• First received: December 19, 2012
• Last updated: December 21, 2012
• Start date: January 2012

Study information

• Verified date: December 2012
• Source: University Medical Center Groningen
• Contact: Adriaan A Voors, MD/PhD
• Phone: +31 50 3612355
• Email: a.a.voors[@]umcg.nl
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Dilated
• Cerebral Hypoperfusion
• Cognition Disorders
• Cognitive Impairment
• Dilated Cardiomyopathy
• Heart Failure
• Perfusion

Locations

Country	Name	City	State
Netherlands	University Medical Centre Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Prevalence of cognitive impairment	Prevalence of cognitive impairment in patients with heart failure	Baseline	No
Secondary	Relation of cognitive impairment with local perfusion	Relation of cognitive impairment with perfusion of carotid artery territory and basilar artery territory	Baseline	No
Secondary	Relation of cognitive impairment with the severity of heart failure	Relation of cognitive impairment with the severity of heart failure	Baseline	No
Secondary	Relation of cognitive impairment with cardiac output	Relation of cognitive impairment with cardiac output	Baseline	No
Secondary	Relation of cognitive impairment with the severity of congestion	Relation of cognitive impairment with the severity of congestion	Baseline	No
Secondary	Relation of cognitive impairment with the decrease in cerebral perfusion	Relation of cognitive impairment with the decrease in cerebral perfusion	Baseline	No
Secondary	The difference of cognitive domains in above relations	The difference of cognitive domains in above relations	Baseline	No