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

U

University Medical Center Groningen (UMCG)

Status

Unknown

Conditions

Cognitive Impairment
Perfusion
Heart Failure
Cerebral Hypoperfusion
Dilated Cardiomyopathy

Study type

Observational

Funder types

Other

Identifiers

NCT01756014
BRAIN-HF

Details and patient eligibility

About

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.

Enrollment

45 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

45 participants in 3 patient groups

Controls
Description:
Age matched healthy subjects
Mild DCM
Description:
Heart failure patients with dilated cardiomyopathy (DCM) with NYHA-functional class II
Severe DCM
Description:
Heart failure patients with dilated cardiomyopathy (DCM) with NYHA-functional class III/IV

Trial contacts and locations

1

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Central trial contact

Adriaan A Voors, MD/PhD

Data sourced from clinicaltrials.gov

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