Brain Function and Perfusion in Patients With Heart Failure (BRAIN-HF)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by University Medical Centre Groningen
Sponsor:
Information provided by (Responsible Party):
A.A.Voors, University Medical Centre Groningen
ClinicalTrials.gov Identifier:
NCT01756014
First received: December 19, 2012
Last updated: December 21, 2012
Last verified: December 2012
  Purpose

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.


Condition
Heart Failure
Dilated Cardiomyopathy
Perfusion
Cognitive Impairment
Cerebral Hypoperfusion

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Brain Function and Perfusion in Patients With Heart Failure

Resource links provided by NLM:


Further study details as provided by University Medical Centre Groningen:

Primary Outcome Measures:
  • Determinants of cerebral impairment [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Determinants of cerebral impairment in patients with heart failure compared to controls, where cerebral impairment is defined as decreased cognitive function and cerebral hypoperfusion


Secondary Outcome Measures:
  • Prevalence of cognitive impairment [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Prevalence of cognitive impairment in patients with heart failure

  • Relation of cognitive impairment with local perfusion [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Relation of cognitive impairment with perfusion of carotid artery territory and basilar artery territory

  • Relation of cognitive impairment with the severity of heart failure [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Relation of cognitive impairment with the severity of heart failure

  • Relation of cognitive impairment with cardiac output [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Relation of cognitive impairment with cardiac output

  • Relation of cognitive impairment with the severity of congestion [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Relation of cognitive impairment with the severity of congestion

  • Relation of cognitive impairment with the decrease in cerebral perfusion [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Relation of cognitive impairment with the decrease in cerebral perfusion

  • The difference of cognitive domains in above relations [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    The difference of cognitive domains in above relations


Estimated Enrollment: 45
Study Start Date: January 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
  • Patients with heart failure due to dilated cardiomyopathy with NYHA II or NYHA II/IV.
  • Healthy patients
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01756014

Contacts
Contact: Adriaan A Voors, MD/PhD +31 50 3612355 a.a.voors@umcg.nl

Locations
Netherlands
University Medical Centre Groningen Recruiting
Groningen, Netherlands, 9700 RB
Contact: Adriaan A Voors, MD/PhD    +31 50 36 12355    a.a.voors@umcg.nl   
Principal Investigator: Adriaan A Voors, MD/PhD         
Principal Investigator: Gert-Jan Luijckx, MD/PhD         
Sub-Investigator: Vincent M van Deursen, MD/PhD         
Sponsors and Collaborators
University Medical Centre Groningen
  More Information

No publications provided

Responsible Party: A.A.Voors, Prof. dr., University Medical Centre Groningen
ClinicalTrials.gov Identifier: NCT01756014     History of Changes
Other Study ID Numbers: BRAIN-HF
Study First Received: December 19, 2012
Last Updated: December 21, 2012
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Cardiomyopathy, Dilated
Heart Failure
Ischemia
Cognition Disorders
Cardiomyopathies
Cardiomegaly
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 21, 2014