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Brain Assessment and Investigation in Heart Failure Trial 2

Brain Assessment and Investigation in Heart Failure Trial 2 - B-HeFT 2

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000020355
Enrollment
80
Registered
2016-01-01
Start date
2016-01-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with Stage B and C heart failure by ACC-AHA guidelines

Interventions

None listed

Sponsors

Department of Cardiovascular Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
(1) Cerebral blood flow (CBF) Comparison between Stage B patients and Stage C patients.

Secondary

MeasureTime frame
(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 ea

Countries

Japan

Contacts

Public ContactHideaki Suzuki

Tohoku University Hospital Department of Cardiovascular Medicine

hd.suzuki.1870031@cardio.med.tohoku.ac.jp+81-22-717-7153

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026