Heart FailureBRAIN-HFNCT01756014
Brain Function and Perfusion in Patients With Heart Failure
An observational study of Heart Failure and Dilated Cardiomyopathy, run by University Medical Center Groningen at 1 site in Netherlands.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure, Dilated Cardiomyopathy, Perfusion
- Type of treatment
- Injection or infusion
- How many people
- 45 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2012to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: * Patients with heart failure due to dilated cardiomyopathy with NYHA II or NYHA II/IV. * Healthy patients
Who may be able to join
- Healthy subject, as assessed by clinician
- Age matched with patient group
- Heart failure due to DCM
- 15 patients with NYHA class II
- 15 patients with NYHA class III/IV
Who cannot join
- 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
Show all 16Show fewer
- Unable or unwilling to provide informed consent
- 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 locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Centre Groningen
Groningen, Provincie Groningen, 9700 RB
Adriaan A Voors, MD/PhD, +31 50 36 12355, a.a.voors@umcg.nl
Adriaan A Voors, MD/PhD
About this study
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.
- Conditions
- Heart Failure, Dilated Cardiomyopathy, Perfusion, Cognitive Impairment, Cerebral Hypoperfusion
- Medical subject headings
- Heart Failure, Cardiomyopathy, Dilated, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Secondary outcomes (7)
Prevalence of cognitive impairment
Prevalence of cognitive impairment in patients with heart failure
Measured: Baseline
Relation of cognitive impairment with local perfusion
Relation of cognitive impairment with perfusion of carotid artery territory and basilar artery territory
Measured: Baseline
Relation of cognitive impairment with the severity of heart failure
Relation of cognitive impairment with the severity of heart failure
Measured: Baseline
Relation of cognitive impairment with cardiac output
Relation of cognitive impairment with cardiac output
Measured: Baseline
Relation of cognitive impairment with the severity of congestion
Relation of cognitive impairment with the severity of congestion
Measured: Baseline
Relation of cognitive impairment with the decrease in cerebral perfusion
Relation of cognitive impairment with the decrease in cerebral perfusion
Measured: Baseline
The difference of cognitive domains in above relations
The difference of cognitive domains in above relations
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2012 (estimated)
- Study startJan 2012
- Primary completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, A.A.Voors, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01756014
- Sponsor's protocol ID
- BRAIN-HF
- Acronym
- BRAIN-HF
- Status last verified
- Dec 2012
- First submitted
- 19 Dec 2012
- Last updated
- 24 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 27862767
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Function and Perfusion in Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT01756014
- Acronym / sponsor ID
- BRAIN-HF / BRAIN-HF
- Conditions
- Heart Failure, Dilated Cardiomyopathy, Perfusion, Cognitive Impairment, Cerebral Hypoperfusion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2012 (estimated)
- First posted
- 24 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * Patients with heart failure due to dilated cardiomyopathy with NYHA II or NYHA II/IV. * Healthy patients
Key inclusion criteria (5 listed)
- Healthy subject, as assessed by clinician
- Age matched with patient group
- Heart failure due to DCM
- 15 patients with NYHA class II
- 15 patients with NYHA class III/IV
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
7 secondary outcomes
Prevalence of cognitive impairment
Time frame: Baseline
Relation of cognitive impairment with local perfusion
Time frame: Baseline
Relation of cognitive impairment with the severity of heart failure
Time frame: Baseline
Relation of cognitive impairment with cardiac output
Time frame: Baseline
Relation of cognitive impairment with the severity of congestion
Time frame: Baseline
Relation of cognitive impairment with the decrease in cerebral perfusion
Time frame: Baseline
The difference of cognitive domains in above relations
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2012.
- Derived from this study: PubMed 27862767Erkelens 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Dilated Cardiomyopathy, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adriaan A Voors, MD/PhD (+31 50 3612355, a.a.voors@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determinants of cerebral impairment (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01756014, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2012.