UMIN-CTR Clinical Trial

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

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

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

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.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Department of Cardiovascular Medicine

Institute

Department

Personal name

Organization

Tohoku University Hospital

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2012

Year

07

Month

31

Day

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

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

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 related information

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

Registered date

2012

Year

07

Month

31

Day

Last modified on

2021

Year

08

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010083