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

December 21, 2012 updated by: A.A.Voors, University Medical Center Groningen
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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Groningen, Netherlands, 9700 RB
        • Recruiting
        • University Medical Centre Groningen
        • Contact:
        • Principal Investigator:
          • Adriaan A Voors, MD/PhD
        • Principal Investigator:
          • Gert-Jan Luijckx, MD/PhD
        • Sub-Investigator:
          • Vincent M van Deursen, MD/PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of cognitive impairment
Time Frame: Baseline
Prevalence of cognitive impairment in patients with heart failure
Baseline
Relation of cognitive impairment with local perfusion
Time Frame: Baseline
Relation of cognitive impairment with perfusion of carotid artery territory and basilar artery territory
Baseline
Relation of cognitive impairment with the severity of heart failure
Time Frame: Baseline
Relation of cognitive impairment with the severity of heart failure
Baseline
Relation of cognitive impairment with cardiac output
Time Frame: Baseline
Relation of cognitive impairment with cardiac output
Baseline
Relation of cognitive impairment with the severity of congestion
Time Frame: Baseline
Relation of cognitive impairment with the severity of congestion
Baseline
Relation of cognitive impairment with the decrease in cerebral perfusion
Time Frame: Baseline
Relation of cognitive impairment with the decrease in cerebral perfusion
Baseline
The difference of cognitive domains in above relations
Time Frame: Baseline
The difference of cognitive domains in above relations
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Groningen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

December 19, 2012

First Submitted That Met QC Criteria

December 21, 2012

First Posted (Estimate)

December 24, 2012

Study Record Updates

Last Update Posted (Estimate)

December 24, 2012

Last Update Submitted That Met QC Criteria

December 21, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRAIN-HF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Heart Failure

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Costa Rica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe