UMIN-CTR Clinical Trial

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.

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

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 Hideaki Middle name Last name Suzuki
Organization	Tohoku University Hospital
Division name	Department of Cardiovascular Medicine
Zip code	980-8574
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 Hideaki Middle name Last name Suzuki
Organization	Tohoku University Hospital
Division name	Department of Cardiovascular Medicine
Zip code	980-8574
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

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	Ethics Committee Tohoku University Hospital
Address	1-1, Seiryo, Aoba, Sendai, Japan
Tel	+81-22-717-3964
Email	ec@rinri.hosp.tohoku.ac.jp

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	https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&recptno=R000010083&ty
Publication of results	Published

Result
URL related to results and publications	http://www.ncbi.nlm.nih.gov/pubmed/27295999
Number of participants that the trial has enrolled	80
Results	1. Reduction in hippocampus blood flow is associated with depressive symptoms and cognitive impairment in chronic heart failure patients.
Results date posted	2021 Year 08 Month 15 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Stage B and C heart failure patients (N=40) with 65.0+-10.9 (men) and 66.8+-8.9 (women) years of age.
Participant flow	We initially enrolled a total of 116 patients, including 56 with　asymptomatic Stage B and 60 with symptomatic Stage C chronic heart failure from August 2012 to April 2013. Of these, 18 patients withheld consent and 18 patients had ineligible or incomplete exams. Finally, 40 Stage B and 40 Stage C heart failure patients were analyzed.
Adverse events	No adverse events.
Outcome measures	Cerebral blood flow and brain grey and white matter volume or concentration
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2012 Year 06 Month 26 Day
Date of IRB	2012 Year 06 Month 15 Day
Anticipated trial start date	2012 Year 08 Month 01 Day
Last follow-up date	2013 Year 12 Month 31 Day
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	2021 Year 08 Month 15 Day

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