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

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ClinicalTrials.gov Identifier: NCT01756014
Recruitment Status : Unknown
Verified December 2012 by A.A.Voors, University Medical Center Groningen.
Recruitment status was:  Recruiting
First Posted : December 24, 2012
Last Update Posted : December 24, 2012
Sponsor:
Information provided by (Responsible Party):
A.A.Voors, University Medical Center Groningen

Tracking Information
First Submitted Date December 19, 2012
First Posted Date December 24, 2012
Last Update Posted Date December 24, 2012
Study Start Date January 2012
Estimated Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 21, 2012)
Determinants of cerebral impairment [ Time Frame: Baseline ]
Determinants of cerebral impairment in patients with heart failure compared to controls, where cerebral impairment is defined as decreased cognitive function and cerebral hypoperfusion
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: December 21, 2012)
  • Prevalence of cognitive impairment [ Time Frame: Baseline ]
    Prevalence of cognitive impairment in patients with heart failure
  • Relation of cognitive impairment with local perfusion [ Time Frame: Baseline ]
    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 ]
    Relation of cognitive impairment with the severity of heart failure
  • Relation of cognitive impairment with cardiac output [ Time Frame: Baseline ]
    Relation of cognitive impairment with cardiac output
  • Relation of cognitive impairment with the severity of congestion [ Time Frame: Baseline ]
    Relation of cognitive impairment with the severity of congestion
  • Relation of cognitive impairment with the decrease in cerebral perfusion [ Time Frame: Baseline ]
    Relation of cognitive impairment with the decrease in cerebral perfusion
  • The difference of cognitive domains in above relations [ Time Frame: Baseline ]
    The difference of cognitive domains in above relations
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Brain Function and Perfusion in Patients With Heart Failure
Official Title Brain Function and Perfusion in Patients With Heart Failure
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population
  • Patients with heart failure due to dilated cardiomyopathy with NYHA II or NYHA II/IV.
  • Healthy patients
Condition
  • Heart Failure
  • Dilated Cardiomyopathy
  • Perfusion
  • Cognitive Impairment
  • Cerebral Hypoperfusion
Intervention Not Provided
Study 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
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: December 21, 2012)
45
Original Estimated Enrollment Same as current
Study Completion Date Not Provided
Estimated Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number NCT01756014
Other Study ID Numbers BRAIN-HF
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party A.A.Voors, University Medical Center Groningen
Study Sponsor University Medical Center Groningen
Collaborators Not Provided
Investigators Not Provided
PRS Account University Medical Center Groningen
Verification Date December 2012