UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020355 |
|---|---|
| Receipt number | R000023483 |
| Scientific Title | Brain Assessment and Investigation in Heart Failure Trial 2 |
| Date of disclosure of the study information | 2016/01/01 |
| Last modified on | 2024/12/31 23:14:42 |
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Basic information
Public title
Brain Assessment and Investigation in Heart Failure Trial 2
Acronym
B-HeFT 2
Scientific Title
Brain Assessment and Investigation in Heart Failure Trial 2
Scientific Title:Acronym
B-HeFT 2
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 follow-up examination of brain and cardiac magnetic resonance imaging (MRI) in B-HeFT.
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, 12, 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 brain derived neurotrophic factor (BDNF)
In (9), it is analyzed whether BDNF is 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)-(9), 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 (2)-(9), a composite of all-cause death or unplanned hospitalization for worsening heart failure, all-cause death, and unplanned hospitalization for worsening heart failure are analyzed by comparing the group with higher than 50th percentile and the group with lower than 50th percentile (N=20 each) in Stage B or C group.
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, who have already registered in B-HeFT, 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
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
hd.suzuki.1870031@cardio.med.tohoku.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine
Institute
Department
Personal name
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
not aplicable
Address
not aplicable
Tel
not aplicable
not aplicable
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
| 2016 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
https://rctportal.niph.go.jp/detail/um?trial_id=UMIN000020355
Publication of results
Partially published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/31955976/
Number of participants that the trial has enrolled
80
Results
Suzuki H et al. showed that baseline anterior hippocampal cerebral blood flow was negatively correlated with changes in left ventricular posterior wall thickness.
Results date posted
| 2024 | Year | 12 | Month | 31 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We enrolled 40 Stage B and 40 Stage C CHF patients aged 45-90 years from August 2012 to April 2013.
Participant flow
We initially enrolled a total of 116 patients, including 56 with Stage B and 60 with Stage C CHF, aged 45-90 years, from August 2012 to April 2013. Exclusion criteria were as follows: contraindication of cardiac MRI, unstable cardiac function, past history that could have significantly affected CBF and/or brain structure, and difficulties in evaluating the brain and/or MRI. Finally, 40 patients in each group were enrolled.
Adverse events
None
Outcome measures
Cerebral blood flow
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2015 | Year | 12 | Month | 22 | Day |
Date of IRB
| 2015 | Year | 12 | Month | 22 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
B-HeFT 2 is an observational study (cohort study). The study targets are 80 patients who have already recruited in B-HeFT. The patients who have written-informed consent in Tohoku University Hospital between 2016/1/1 and 2016/3/31 will receive brain and cardiac MRI, psychological tests and blood sampling.
Management information
Registered date
| 2015 | Year | 12 | Month | 25 | Day |
Last modified on
| 2024 | Year | 12 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023483
