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Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000008584
Receipt No. R000010083
Scientific Title Brain Assessment and Investigation in Heart Failure Trial
Date of disclosure of the study information 2012/07/31
Last modified on 2017/02/02

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Basic information
Public title Brain Assessment and Investigation in Heart Failure Trial
Acronym B-HeFT
Scientific Title Brain Assessment and Investigation in Heart Failure Trial
Scientific Title:Acronym B-HeFT
Region
Japan

Condition
Condition Patients with Stage B and C heart failure by ACC-AHA guidelines
Classification by specialty
Medicine in general Cardiology Neurology
Psychosomatic Internal Medicine Geriatrics Psychiatry
Radiology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to investigate a possible influence of heart failure on brain functions and structures such as cerebral blood flow (CBF) using brain and cardiac magnetic resonance imaging (MRI).
Basic objectives2 Others
Basic objectives -Others Cerebral blood flow (CBF) is measured by arterial spin labeling (ALS) perfusion imaging.
Analysis of CBF is performed using the statistical parametric mapping software (SPM8, the Wellcome Trust Centre for Neuroimaging, London, UK) implemented in MATLAB (Mathworks Inc, Natick, MA, USA).
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes (1) Cerebral blood flow (CBF)
Comparison between Stage B patients and Stage C patients.
Key secondary outcomes (2) CBF
It is analyzed whether CBF is associated with cardiac index (CI), total brain volume (TBV), grey matter (GM), white matter (WM), white matter hyperintensities (WMI) and/or intima media thickness (IMT).

(3) TBV, GM and WM
It is analyzed whether TBV, GM and/or WM are associated with CI, WMH and/or IMT.

(4) WMH
It is analyzed whether WMH is associated with CI and/or IMT.

(5) IMT
It is analyzed whether IMT is associated with CI.

(6) Depressive symptoms evaluated by Beck depression Inventory (BDI) and geriatric depression scale (GDS).
(7) Cognitive function and mild cognitive impairment (MCI) evaluated by mini-mental state examination (MMSE), frontal assessment battery (FAB) and Wechsler memory scale-reviced (WMS-R).
(8) Quality of life (QOL) evaluated by Minnesota living with heart failure questionnaire.

In (6)-(8), it is analyzed whether depressive symptoms, cognitive function, MCI and/or QOL are associated with CBF, CI, TBV, GM, WM, WMH and/or IMT.

(9) Blood unsaturated fatty acid (omega-3 fatty acids, omega-6 fatty acids, alpha-linolenic acid, docosahexaenoic acid and eicosapentaenoic acid)
(10) Blood brain derived neurotrophic factor (BDNF)
(11) Blood amyloid beta (A-beta 40 and A-beta 42)

In (9)-(11), it is analyzed whether unsaturated fatty acid, BDNF and/or amyloid beta are associated with CBF, CI, TBV, GM, WM, WMH and/or IMT.

In (2), comparison among Stage B/C patients with ischemic/nonischemic heart diseases, comparison between patients with heart failure with reduced ejection fraction (HFREF) and patients with heart failure with preserved ejection fraction (HFPEF) and comparison among NYHA classes are analyzed.

In (3)-(11), comparison between Stage B patients and Stage C patients, comparison among Stage B/C patients with ischemic/nonischemic heart diseases, comparison between patients with HFREF and patients with HFPEF and comparison among NYHA classes are analyzed.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
45 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria Patients with Stage B and C heart failure by ACC-AHA guidelines with a written informed consent.
Key exclusion criteria (1) Contraindication of MRI:
Cardiac devices or claustrophobia.

(2) Unstable cardiac function:
Patients who had uncontrolled heart failure or required intravenous inotropes.

Patients receiving stent implantation for acute myocardial infarction
within 3 months.

(3) Past history significantly affecting cerebral blood flow and/or brain structure:
MMSE < 24, mental retardation, neurodegenerative disease, psychiatric disorder, epilepsy, symptomatic stroke, symptomatic carotid stenosis with or without stenting or endarterectomy, head trauma, hydrocephalus, intracranial mass, alcohol/drug addiction, hypo/hyperthyroidism, aortic stenosis proximal to left cervical artery and/or severe aortic valve stenosis.

(4) Difficulty in evaluating brain and/or cardiac MRI:
Artifacts of movements or other causes.

Patients with complex congenital heart diseases.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroaki Shimokawa
Organization Tohoku University Hospital
Division name Department of Cardiovascular Medicine
Zip code
Address 1-1, Seiryo, Aoba, Sendai, Japan
TEL +81-22-717-7153
Email hd.suzuki.1870031@cardio.med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hideaki Suzuki
Organization Tohoku University Hospital
Division name Department of Cardiovascular Medicine
Zip code
Address 1-1, Seiryo, Aoba, Sendai
TEL +81-22-717-7153
Homepage URL
Email hd.suzuki.1870031@cardio.med.tohoku.ac.jp

Sponsor
Institute Department of Cardiovascular Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Tohoku University Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2012 Year 07 Month 31 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/27295999
Number of participants that the trial has enrolled
Results
1. Reduction in hippocampus blood flow is associated with depressive symptoms and cognitive impairment in chronic heart failure patients.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2012 Year 06 Month 26 Day
Date of IRB
Anticipated trial start date
2012 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Patients' information is blinded to a person analyzing data of brain and cardiac MRI

Management information
Registered date
2012 Year 07 Month 31 Day
Last modified on
2017 Year 02 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010083


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